Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Eye irritation: 
- Key: eye damaging category 1 according to EU criteria. 
- Supporting: eye damage category 1 according to EU criteria.

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:
adverse effect observed (irritating)

Additional information

Skin irritation

Please refer to ECHA disseminated dossier.

Eye irritation

Supporting study

Please refer to ECHA disseminated dossier.

Supporting study

ECETOC 1998 (Technical Report No. 48 (2) )

The test item was applied to one white New zealand rabbit and was conducted according to OECD guideline 405. An unchanged application was chosen with a concentration of 100 %. Eye irritation was evaluated according to the criteria of Draize et al. at 1, 24, 48 and 72 h. Corneal, iridal and conjunctival effects were observed and were not reversible. The mean scores at 24/48/72 hours obtained from 1 animals were as following:

Cornea opacity: 4

Iris: 2

Conjunctive redness: 3

Chemosis: 3.67

These range-finding results indicate that the test item is categorized as severely eye damaging. According to the CLP (EC) No 1272/2008 classification criteria the test item has to be classified into cat. 1. According to DSD 67/548/EEC it has to be classified as Xi, R41.

 

 

 

 

 

 


Justification for selection of skin irritation / corrosion endpoint:
Reliable guideline study (OECD 404). No GLP study.

Justification for selection of eye irritation endpoint:
Reliable guideline study (OECD 404). No GLP study.

Effects on eye irritation: corrosive

Justification for classification or non-classification

Skin irritation

 

Dangerous Substance Directive (67/548/EEC)
The available studies are considered reliable and suitable for classification purposes under Directive 67/548/EEC. As a result the substance is not considered to be classified for skin irritation under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EG.

 

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is not considered to be classified for skin irritation under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation (EC) No 605/2014.

 

 

Eye irritation

 

Dangerous Substance Directive (67/548/EEC)
The available study is considered reliable and suitable for classification purposes under Directive 67/548/EEC. As a result the substance is considered to be classified for eye irritation Xi, R41: Risk of serious damage to eyes under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EG.

 

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is considered to be classified for eye irritation cat. 1, H318: Causes serious eye damage under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation (EC) No 605/2014.