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
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The key study (Monsanto 1985) was the most recent and reliable study available for assessment.
0.3 ml of the test material was applied at induction and challenge as a 100% solution. The test material, Dequest 2046 is known to have 35.7% active salt content at pH 6 -8, 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 salt to acid equivalent for mass for EDTMP-6Na salt is 0.768. Therefore, based on the known active salt proportion of the substance, it is calculated that the at application to animal skin amount of active salt is 400 mg, and active acid 300 mg.
A combined irritation and sensitisation study was also available in man (Monsanto 1981). However, the study report does not explain how the challenge phase was conducted with more than one material tested, each material having been assigned separate, simultaneous contact sites for both the induction and challenge phases. While the method is not acceptable for sensitisation study, the results support the key findings reporting EDTMP sodium salt to be not sensitising. No mention of GLP is included in the study.
Migrated from Short description of key information:
A reliability 2 study in guinea pig reports the test material as not sensitising (Monsanto 1985).
Justification for classification or non-classification
Based on the available information, the sodium salt of EDTMP does not require classification for sensitisation in accordance with current regulation (EC 1272/2008).
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