Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 
in vivo (rabbit): not irritant; OECD Guideline 404, GLP, Safepharm Laboratories Ltd, 1235/004, 1998. 
Eye Irritation: 
in vivo (rabbit): not irritant; OECD Guideline 405, GLP, Safepharm Laboratories Ltd, 1235/005, 1998

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)

Additional information

There are valid in vivo data available for the assessment of the skin and eye irritation potential of the test item.

Skin Irritation / Corrosion

The key study, a primary skin irritation study, was performed according to GLP and OECD Guideline 404 (Acute Dermal Irritation/Corrosion) with 0.5 g of the moistened (distilled water) test item (analytical purity unknown) applied for 4 hours to the clipped skin of each of three 12 to 14 weeks old New Zealand White rabbits under semi-occlusive conditions (Safepharm, 1235/004, 1998). The scoring of skin reactions was performed 1, 24, 48 and 72 hours, as well as 7, 10 and 14 days after removal of the test item according to the Draize classification scheme. No signs of skin irritation or skin corrosion were seen. No other signs of intoxication were observed.  

Conclusion: Under the test conditions chosen, the test item did not induce any irritation or corrosion to the skin and is considered to be not irritating to rabbit skin.

 

Eye Irritation

In the key eye irritation study, conducted according OECD Guideline 405 (Acute Eye Irritation/Corrosion), 0.1 ml of the undiluted test article (analytical purity unknown) was instilled into the non-irrigated eye of each of three 12 to 14 weeks old New Zeeland White rabbits (3 males) (Safepharm, 1235/005, 1998). Eyes were not washed after instillation. Irritation was scored 1, 24, 48 and 72 hours after treatment according to the Draize classification scheme. No signs of eye irritation were seen in treated eyes 24, 48 and 72 hours after treatment. No other signs of intoxication were observed.

Conclusion: Under the test conditions chosen, the test item did not induce significant irritation to the eye and is considered to be not irritating to the rabbit eye.

Respiratory Irritation

There are no data available.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available experimental test data are reliable and suitable for the purpose of classification under Directive 67/548/EEC. Based on the data, classification for skin and eye irritation is not warranted under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.

 

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

The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008. Based on the data, classification for skin and eye irritation is not warranted under Regulation (EC) No.1272/2008.