Registration Dossier
Registration Dossier
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EC number: 221-221-0 | CAS number: 3033-77-0
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:
In a dermal sensitization study, equivalent to a OECD 406 guideline, EPTAC was tested in guinea-pigs using the Maximisation Test method (20 animals treated and 20 controls).
EPTAC diluted at 5% in vaseline was administered by intradermal injection. Topical induction was performed with EPTAC diluted at 5% in vaseline. EPTAC was tested at 2.5% for the challenge.
In the topical induction phase, there was slight erythema noted after 24 hours.
Dermal reactions were observed in 14 of the 20 guinea-pigs treated and no reactions have been observed in the control animals. More than 30% of the animal tested showed positive reactions.
Moreover, human data are available and are in accordance with animals conclusions.
Actually, in several cases of workers who developped skin disease caused by exposure to epoxy compounds, patch tests have been perfomed. Several dilutions of EPTAC have been applied in the back of patients with an application time of 24h in general. The results were read 24, 48 and 72h after removal and dermatologist scored the skin reactions.
Positive test results showed that EPTAC is considered as a skin sensitizer.
Therefore, regarding the data available both in animals and humans, EPTAC is classified as a skin sensitizer according to criteria of the Annex VI to the CLP Regulation (EC) N° 1272/2008 and to the criteria of the Annex VI to the Directive 67/548/EEC.
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Migrated from Short description of key information:
Study in animals: In a dermal sensitization study, OECD 406 guideline, more than 30% of the animal tested showed positive reactions.
Human data: Patch tests in patients suffering from skin diseases showed positive results.
Justification for classification or non-classification
Harmonised classification:
EPTAC is classified as Skin Sens. 1 (H317: May cause an allergic skin reaction) ) in the Annex VI, Table 3.1 of the CLP regulation (No 1272/2008) and as Xi R43 (May cause sensitisation by skin contact) in the Annex VI, Table 3.2 of the CLP regulation (1272/2008).
No additional self-classification is proposed.
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