Registration Dossier
Registration Dossier
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EC number: 203-328-4 | CAS number: 105-76-0
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Dibutyl maleate was positive in a Guinea pig Magnusson-Kligman maximization test, conducted according to OECD Guideline 406 (RL1). Also, unreliable human patch tests have reported positive skin sensitization reactions with dibutyl maleate initiated after
employees developed contact dermatitis.Glue formulations containing 5% and 10% dibutyl maleate were evaluated in twenty and twenty five subjects, respectively in two separate patch tests (RL4) . There was evidence of a positive reaction at 10% after 24 h contact and at 5% after 48, and 96 hours contact.Overall, it can be concluded from the evidence available that dibutyl maleate is a skin sensitizer.
Migrated from Short description of key information:
Animal experiments, case reports and patch testing suggest that dibutyl maleate is a skin sensitizer.
Respiratory sensitisation
Endpoint conclusion
- Additional information:
- Migrated from Short description of key information:
No data available for evaluation
Justification for classification or non-classification
According to Regulation (EC) No 1272/2008, dibutyl maleate is classified as skin sensitizer sub-category 1B.
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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