Registration Dossier
Registration Dossier
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EC number: 262-992-3 | CAS number: 61788-64-5
Toxicity to microorganisms
Administrative data
Link to relevant study record(s)
Description of key information
EC 50 = 10000 mg/L
Key value for chemical safety assessment
- EC50 for microorganisms:
- 10 000 mg/L
Additional information
This highly insoluble substance makes aquatic toxicity testing impractical. A data waiver is specified.
According to the REACH Regulation, annex VIII, section 9.1.4, Column 2 “Specific rules for adaptation from Column 1”the study does not need to be conducted if:
1. there is no emission to a sewage treatment plant; or
2. there are mitigating factors indicating that microbial toxicity is unlikely to occur, for instance the substance is highly insoluble in water; or
3. the substance is found to be readily biodegradable and the applied test concentrations are in the range of concentrations that can be expected in the influent of a sewage treatment plant.
Regarding point 2, the substance is technically highly insoluble in water, with a water solubility < 0.6 mg/l, but the substance also exhibits significant surface active properties and it forms very fine and stable dispersions. In this respect the substance is in a certain extent available into the water compartment, therefore the specific mitigating effect do not completely apply.
On the other side, according to the estimation and weight of evidence, the substance can be considered as readily biodegradable and the estimated PEC, according to the Exposure scenarios, are in the range of 2.77x10-4-3.82x10-6mg/l, well below the applied test concentrations.
ES 1: Manufacturing |
Local PEC:5.84E-5 mg/L |
RCR = 0.014 |
ES 2: Cosmetics-Formulation or re-packing |
Local PEC: 2.77E-4 mg/L |
RCR = 0.064 |
ES 3: Cosmetics- Consumer use |
Local PEC: 3.76E-6 mg/L |
RCR < 0.01 |
ES 4: Leather - Formulation |
Local PEC: 5.84E-5 mg/L |
RCR = 0.014 |
ES 5: Leather – Use at industrial site |
Local PEC: 5.84E-5 mg/L |
RCR = 0.014 |
ES 6: Textile - Formulation |
Local PEC: 5.84E-5 mg/L |
RCR = 0.014 |
ES 7: Textile – Use at industrial site |
Local PEC: 5.84E-5 mg/L |
RCR = 0.014 |
ES 8: Coatings and Paints - Formulation |
Local PEC: 5.84E-5 mg/L |
RCR = 0.014 |
ES 9: Coatings and Paints – Use at industrial site |
Local PEC: 4.47E-5 mg/L |
RCR = 0.01 |
ES 10: Coatings and Paints – Professional use |
Local PEC: 3.82E-6 mg/L |
RCR < 0.01 |
ES 11: Coatings and Paints – Professional use |
Local PEC: 3.76E-6 mg/L |
RCR < 0.01 |
ES 12: Washing and Cleaning - Formulation |
Local PEC: 9.16E-6 mg/L |
RCR < 0.01 |
ES 13: Washing and Cleaning - Use at industrial site |
Local PEC: 2.77E-4 mg/L |
RCR = 0.064 |
ES 14: Biocides - Formulation |
Local PEC: 3.1E-5 mg/L |
RCR < 0.01 |
ES 15: Biocides - Use at industrial site |
Local PEC: 3.1E-5 mg/L |
RCR < 0.01 |
ES 16: Biocides - Professional use |
Local PEC: 7.46E-6 mg/L |
RCR < 0.01 |
ES 17: Biocides - Consumer use |
Local PEC: 7.46E-6 mg/L |
RCR < 0.01 |
ES 18: Filler and Putties- Formulation |
Local PEC: 5.84E-5 mg/L |
RCR = 0.014 |
ES 19: Filler and Putties - Use at industrial site |
Local PEC: 2.56E-5 mg/L |
RCR < 0.01 |
ES 20: Filler and Putties - Professional use |
Local PEC: 3.82E-6 mg/L |
RCR < 0.01 |
ES 21: Base metal and alloys- Formulation |
Local PEC: 6.43E-6 mg/L |
RCR < 0.01 |
ES 22: Base metal and alloys - Use at industrial site |
Local PEC: 5.06E-6 mg/L |
RCR < 0.01 |
ES 23: Fuels- Formulation |
Local PEC: 3.1E-5 mg/L |
RCR < 0.01 |
ES 24: Flocculants- Formulation |
Local PEC: 1.46E-5 mg/L |
RCR < 0.01 |
ES 25: Flocculants- Use at industrial site |
Local PEC: 9.16E-6 mg/L |
RCR < 0.01 |
ES 26: Polishes and wax blends- Formulation |
Local PEC: 1.46E-5 mg/L |
RCR < 0.01 |
ES 27: Polishes and wax blends- Use at industrial site |
Local PEC: 9.16E-6 mg/L |
RCR < 0.01 |
Based on the article of Dahong Sun 2008 (Sun, Danhong; He, Qiang; Zhang, Wenjun; Xin, Liu; Shi, Bi, Evaluation of environmental impact of typical leather chemicals: Part I biodegrability of fatliquors in activated sludge treatment, Journal of the Society of Leather Technologists and Chemists (2008), 92(1), 14-18. Language: English), sulphated castor oil not only showed a good biodegradability rate, but also no inhibilition of the respiration has been reported at any dose up to 1500 mg/l over 5 days
Read across from a similar substance (rape oil, sulphonated, sodium salt, EC 293-618-7) estimates no effects on the respiration of Psuedomonas putida at loading rates up to 10,000 mg/l (4900 mg/l active substance) (WAF testing approach taken). This result indicates a substance with low aquatic toxicity.
No effect loading = 10,000 mg/L
The substance used in read across is FLL Sample 9
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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