Registration Dossier

Administrative data

Description of key information

Skin irritation: Not irritating (OECD 404, GLP, Rel.2, K).
Eye irritation: Not irritating (OECD 405, GLP, Rel. 2, K).

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)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

A key study was identified (CIT, 2001, rel. 2). This dermal irritation study was performed according to the OECD Guideline No. 404, and in compliance with GLP.

A very slight erythema was noted in all animals on Day 1; it persisted up to Day 2 in one animal and up to Day 3 in another one. No other cutaneous reactions were observed.

The individual scores for each animal within 3 scoring times (24, 48 and 72 h) were 0.7 / 0.0 / 0.3 for erythema and 0.0 / 0.0 / 0.0 for oedema

 

Eye irritation:

A key study was identified (CIT, 2002, Rel. 2). This eye irritation study was performed according to the OECD Guideline No. 405, and in compliance with GLP.

No corneal or iridial effects were noted during the study. Conjunctivae redness (grade 1) was noted in all animals at 1 hour after exposure; completely reversible within 24 hours. No other ocular reactions were observed.

Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 0.0 / 0.0 / 0.0 for cornea score; 0.0 / 0.0 / 0.0 for iris score; 0.0 / 0.0 / 0.0 for conjunctivae score and 0.0 / 0.0 / 0.0 for chemosis score.

Justification for classification or non-classification

Harmonized classification:

The substance has no harmonized classification for irritation or corrosion according to the Regulation (EC) No. 1272/2008.

Self classification:

Based on the available data no additional self-classification is proposed regarding both skin and eye irritation according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.

No data was available regarding respiratory irritation, however the substance not being classified for skin and eye irritation, no classification is expected for respiratory irritation.