SECTION 12: Ecological Information
Section 12 of the Safety Data Sheet (SDS) provides crucial information about the environmental impacts of chemicals, helping users understand potential risks to ecosystems and implement appropriate environmental protection measures. This section is essential for environmental risk assessment and compliance with environmental regulations.
Key Components of Section 12
- Toxicity: Information on acute and chronic toxicity to aquatic and terrestrial organisms, including fish, invertebrates, algae, microorganisms, and plants.
- Persistence and Degradability: Data on biodegradation, hydrolysis, photolysis, and other degradation processes that determine how long a substance remains in the environment.
- Bioaccumulative Potential: Assessment of a substance's ability to accumulate in organisms and move up the food chain, typically measured by bioconcentration factors (BCF) and partition coefficients (log Kow).
- Mobility in Soil: Information on how a substance moves through soil and potentially reaches groundwater, including adsorption coefficients and leaching potential.
- PBT and vPvB Assessment: Evaluation of whether the substance meets criteria for persistent, bioaccumulative, and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances.
- Other Adverse Effects: Additional environmental concerns such as ozone depletion potential, photochemical ozone creation potential, or endocrine disrupting properties.
Regulatory Framework
The ecological information requirements are governed by several regulations:
- REACH Regulation (EC) No 1907/2006, Annex II
- CLP Regulation (EC) No 1272/2008
- Regulation (EU) 2020/878 (amending REACH Annex II)
- GHS (Globally Harmonized System)
- National environmental protection regulations
Recent Updates:
The 2020/878 amendment to REACH Annex II introduced new requirements for reporting endocrine disrupting properties and enhanced requirements for PBT/vPvB assessments.
Aquatic Toxicity Classification
Under CLP/GHS, aquatic toxicity is classified as:
| Category | Acute Toxicity | Chronic Toxicity |
|---|---|---|
| Acute 1 | LC₅₀/EC₅₀/ErC₅₀ ≤ 1 mg/L | - |
| Chronic 1 | LC₅₀/EC₅₀/ErC₅₀ ≤ 1 mg/L | NOEC or ECx ≤ 0.1 mg/L |
| Chronic 2 | 1 < LC₅₀/EC₅₀/ErC₅₀ ≤ 10 mg/L | 0.1 < NOEC or ECx ≤ 1 mg/L |
| Chronic 3 | 10 < LC₅₀/EC₅₀/ErC₅₀ ≤ 100 mg/L | 1 < NOEC or ECx ≤ 10 mg/L |
M-Factors
M-factors (multiplication factors) are used for substances that are highly toxic to aquatic organisms at concentrations below 1 mg/L. They increase the weight given to highly toxic components when classifying mixtures.
M-Factor Assignment:
| L(E)C₅₀ Value | M-Factor |
|---|---|
| 0.1 < L(E)C₅₀ ≤ 1 mg/L | 1 |
| 0.01 < L(E)C₅₀ ≤ 0.1 mg/L | 10 |
| 0.001 < L(E)C₅₀ ≤ 0.01 mg/L | 100 |
| 0.0001 < L(E)C₅₀ ≤ 0.001 mg/L | 1000 |
Similar M-factors apply for chronic toxicity based on NOEC values.
Biodegradation Assessment
Biodegradation is a key parameter for assessing environmental persistence:
- Ready biodegradability: ≥ 60% degradation within 28 days (CO₂ evolution) or ≥ 70% (oxygen depletion or DOC removal)
- Inherent biodegradability: > 20% and < 60% degradation within 28 days
- Not biodegradable: < 20% degradation within 28 days
Standard Test Methods:
- OECD 301 A-F: Ready Biodegradability
- OECD 302 A-C: Inherent Biodegradability
- OECD 306: Biodegradability in Seawater
- OECD 309: Aerobic Mineralization in Surface Water
Bioaccumulation Assessment
Bioaccumulation potential is typically assessed using:
- Log Kow (octanol-water partition coefficient):
- Log Kow < 3: Low potential
- 3 ≤ Log Kow < 4: Moderate potential
- Log Kow ≥ 4: High potential
- BCF (bioconcentration factor):
- BCF < 100: Low potential
- 100 ≤ BCF < 2000: Moderate potential
- BCF ≥ 2000: High potential
- BCF ≥ 5000: Very high potential (vB criterion)
For complex substances or when log Kow is not appropriate (e.g., for surfactants, highly adsorptive substances), direct measurement of BCF is preferred.
Soil Mobility Assessment
Mobility in soil is typically assessed using:
- Koc (organic carbon-water partition coefficient):
- Koc < 50: Very mobile
- 50 ≤ Koc < 150: Mobile
- 150 ≤ Koc < 500: Moderately mobile
- 500 ≤ Koc < 2000: Slightly mobile
- Koc ≥ 2000: Immobile
- Kd (soil-water partition coefficient)
- Henry's Law Constant (for volatility from soil)
Standard Test Methods:
- OECD 106: Adsorption/Desorption
- OECD 121: Estimation of Koc by HPLC
- OECD 312: Leaching in Soil Columns
PBT and vPvB Assessment
Under REACH, substances are assessed against the following criteria:
| Criterion | PBT | vPvB |
|---|---|---|
| Persistence | Half-life: >60 days (marine water) >40 days (fresh water) >180 days (marine sediment) >120 days (freshwater sediment) |
Half-life: >60 days (marine or fresh water) >180 days (marine or freshwater sediment) |
| Bioaccumulation | BCF > 2000 | BCF > 5000 |
| Toxicity | NOEC < 0.01 mg/L or CMR or Endocrine disrupting |
Not applicable |
Subsections of Section 12
Section 12 is divided into the following subsections, each addressing specific aspects of ecological information:
- 12.1 Toxicity - Information on the toxic effects on aquatic and terrestrial organisms
- 12.2 Persistence and degradability - Data on biodegradation and environmental persistence
- 12.3 Bioaccumulative potential - Assessment of bioaccumulation in organisms and food chains
- 12.4 Mobility in soil - Information on movement through soil and potential groundwater contamination
- 12.5 Results of PBT and vPvB assessment - Evaluation against persistent, bioaccumulative, and toxic criteria
- 12.6 Other adverse effects - Additional environmental concerns not covered in other subsections
Critical Requirements
- All ecological data must be consistent with classification and labeling in Section 2
- Information must be provided for each relevant environmental compartment (aquatic, terrestrial, atmospheric)
- M-factors must be specified for substances classified as Aquatic Acute 1 or Aquatic Chronic 1
- Endocrine disrupting properties must be indicated when available
- PBT/vPvB assessment results must be clearly stated
- Environmental fate and behavior information must be included
Environmental Impact Assessment
| Impact Category | Assessment Parameters | Significance |
|---|---|---|
| Aquatic Toxicity | LC50, EC50, NOEC values | Effects on aquatic organisms |
| Terrestrial Toxicity | Soil organism toxicity | Impact on land ecosystems |
| Environmental Fate | Degradation pathways | Long-term environmental presence |
| Bioaccumulation | BCF, log Kow values | Accumulation in food chains |
| Atmospheric Effects | ODP, GWP, POCP | Impact on air quality and climate |
Quality Assurance Checklist
- Verify consistency between ecological data and environmental hazard classification
- Ensure all mandatory subsections are completed with relevant data
- Validate that test methods comply with OECD or equivalent guidelines
- Check that data is species-specific and includes exposure conditions
- Confirm that PBT/vPvB assessment is complete and follows REACH criteria
- Verify that M-factors are provided for highly toxic substances
- Ensure endocrine disrupting properties are addressed
New Requirements (2023)
- Enhanced reporting of endocrine disrupting properties with environmental relevance
- More detailed PBT and vPvB assessment information
- Specific requirements for nanoforms regarding environmental behavior
- Improved alignment with GHS Rev. 8 for aquatic toxicity classification
- Inclusion of long-term aquatic toxicity data when available
- Consideration of terrestrial toxicity for soil-relevant substances
Atmospheric Effects
Air Quality Impacts
- Ozone Depletion Potential (ODP): Ability to destroy stratospheric ozone, relative to CFC-11
- Global Warming Potential (GWP): Ability to trap heat in the atmosphere, relative to CO₂
- Photochemical Ozone Creation Potential (POCP): Ability to create ground-level ozone (smog)
- Atmospheric Half-life: Persistence in the atmosphere
Example: Aquatic Toxicity Data Presentation
| Species | Endpoint | Value | Test Duration |
|---|---|---|---|
| Oncorhynchus mykiss (Rainbow trout) | LC₅₀ | 10 mg/L | 96 hours |
| Daphnia magna (Water flea) | EC₅₀ | 8.5 mg/L | 48 hours |
| Pseudokirchneriella subcapitata (Green algae) | ErC₅₀ | 12 mg/L | 72 hours |
| Pimephales promelas (Fathead minnow) | NOEC | 1.2 mg/L | 28 days |
Based on this data, the substance would be classified as Aquatic Chronic Category 2.