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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Skin irritation: Not irritating (OECD 404, GLP, Rel.1, K).
Eye irritation: Not irritating (OECD 405, GLP, Rel.1, 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 (Klein, 1994). This dermal irritation study was performed according to the OECD Guideline No. 404, and in compliance with GLP.

1 h after patch removal, very slight erythema (score "1" each) and slight oedema (score "2" each) were observed in 2/3 animals, well-defined erythema (score "2") and moderate pedema (score "3) in the third animal.

At the reading times (24,48 and 72h after patch removal), in all animals very slight erythema (score "1" each) was observed at each reading time. In 1/3 animals slight oedema (score "2") was noted 24h, very slight oedema (score "1") 48h, and a score of "0" 72h after the end of exposure. In other animal, slight oedema was found 24 and 48h, very slight oedema 72h after patch removal. In the third animal, very slight oedema was observed 24h after patch removal, score of "0" at the other reading times. No lesions were observed on Day 6 after the exposure.

The individual scores for each animal within 3 scoring times (24, 48 and 72 h) were 1.0 / 1.0 / 1.0 for erythema and 1.0 / 1.7 / 0.3 for oedema.

A supporting study with a Klimish score of 3 was also identified (Potokar, 1981) and the results are consistent with those of the key study.

Eye irritation:

A key study was identified (Freytag, 1995). This eye irritation study was performed according to the OECD Guideline No. 405, and in compliance with GLP.

1 hour after application, erythema, oedema and discharge was observed in all animals. No reactions of the eyes were observed in any of animals 24 h after application.

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; 0.33 / 0.33 / 0.33 for conjunctivae score and 0.0 / 0.0 / 0.0 for chemosis score. An in vitro supporting study with a Klimisch score of 2 (Steiling, 1995), and an in vivo study with a Klimisch score of 3 (Potokar, 1981) were identified. The results of these studies are consistent with those of the key study.


Justification for selection of skin irritation / corrosion endpoint:
The key study is GLP-compliant and of high quality (Klimisch score = 1).

Justification for selection of eye irritation endpoint:
The key study is GLP-compliant and of high quality (Klimisch score = 1).

Justification for classification or non-classification

Harmonized classification:

The substance has no harmonized classification 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, based on the skin and eye irritation results, respiratory tract irritation is not expected.