Registration Dossier
Registration Dossier
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EC number: 244-742-5 | CAS number: 22036-77-7
Endpoint summary
Administrative data
Description of key information
The key study for skin irritation found the test material to be a non-irritant in man (Monsanto 1981). The test substance was applied undiluted, for 24 hours at a time, repeatedly on human skin over a 4 week period under occlusive dressing.
The key study for eye irritation found no evidence of ocular irritation after a single instillation of the test material into rabbit eye (Safepharm 1982). All irritation scores were 0 at 24, 48 and 72 hours in all animals.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
The most recent and reliable available studies were selected as key. However, several reliable supporting studies were also available for skin irritation (Env. Health. Laboratories 1979, Hazleton Labs 1979, Biodynamics 1985, Safepharm 1982) and eye irritation (Monsanto 1981, Hazleton Labs 1980). The results of the supporting studies were in full agreement with the key findings, reporting only slight irritation at most, insufficient for classification.
In the key study for skin irritation (Monsanto 1981), 0.2 ml of the test material was applied on skin undiluted.
In the key study for eye irritation (Monsanto 1985), 0.1 ml of the test material was applied in the eyes of the animals. The test material, Briquest 422-25S has 25% active acid content and a specific gravity of 1.3 -1.36 g/ cm3.
The pKa of the salt at pH 7.3 is estimated to be 6. The conversion factor to determine the acid to salt equivalent for mass for EDTMP-6Na salt is 1.30241. The estimated active salt content is 32%.
Justification for classification or non-classification
Based on the available studies on EDTMP sodium salt, no classification is applied for skin or eye irritation. The salts tested were in the pH range of 7 -10.5. Only a low degree of irritation is seen which is well below the threshold for classification. However, a set of pKa values exist which allow extrapolation of pHs: at x≤1 is pH≤3; x=8 is pH>10. Therefore, for EDTMP salts where x=1, classification for skin irritation in Category 2 is appropriate, and where x=8 classification for skin irritation in Category 1 is appropriate. In turn, for or eye irritation, where x=1 or 8, classification in Category 1 is applied.
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