Registration Dossier
Registration Dossier
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EC number: 478-130-6 | CAS number: 50940-49-3
Endpoint summary
Administrative data
Description of key information
The corrosive potential to skin and eyes is based on an in-vivo skin-irritation study.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation/corrosion:
Results of an in-vitro study indicated that samples containing different ratio’s of MAHP and MAES were compatible with the Corrositex system and were classified as Category 2 material. The results obtained from the evaluation of three different samples with four replicates per sample were highly reproducible, demonstrating that mean time of > 60 minutes was required to destroy the synthetic biobarriers. These findings lead to the designation of these samples as a non-corrosive. To confirm the non-corrosivity, an additional in-vivo test was performed.
An in-vivo study was performed on the skin of the New Zealand White rabbit. The method was designed to meet the requirements of the following guidelines:
- OECD Guidelines for the Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion" (adopted 24 April 2002)
- Method B4 Acute Toxicity (Skin Irritation) of Commission Directive 2004/73/EC
A single 4-hour, semi-occluded application of the test material to the intact skin of one rabbit produced corrosive effects. Moderate to severe erythema, severe oedema, crust formation, reduced regrowth of fur, glossy skin and areas of scar tissue (up to 5 mm x 5 mm), scattered over and around edges of the treatment site, were also noted. The erythematous reaction extended approximately 5 cm beyond the treatment site and the oedema extended ventrally approximately 5 cm below the treatment site. Semi-occluded applications for 3 minutes or 1 hour to the intact skin of one rabbit produced no corrosive effects.
Eye Irritation:
This study was deemed inappropriate in accordance with Column 2 Adaptation, Annex VII (8.5.2) of REACH Regulation 1272/2008, which state that an eye irritation study does not need to be conducted if the substance is classified as corrosive to the skin and provided that the registrant classified the substance as irritant. The submission substance has been classified as corrosive to the skin with risk of serious damage to the eyes (corrosive) because according to REACH Regulation (EC) 1272/2008 skin corrosive substances shall be considered automatically as leading to serious damage to the eyes (Category 1).
Justification for classification or non-classification
Based on corrosivity at exposure for > 1 hour and ≤ 4 hours, and irreversible effects during ≤ 14 days, MAES is classified as Skin corrosive cat. 1C.
According to REACH Regulation (EC) 1272/2008 skin corrosive substances are considered as leading to serious damage to the eyes as well (Category 1).
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