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Administrative data

Description of key information

SKIN IRRITATION:
The irritation to the skin caused by exposure to 1-bromohexadecane was determined to be moderately irritating in a key study which was performed in line with OECD guideline 404 and EU Method B.4.
EYE IRRITATION:
The irritation to the eyes caused by exposure to 1-bromohexadecane was determined to be non-irritating in a key study which was performed in line with OECD guideline 405 and EU Method B.5.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin Irritation

A robust GLP compliant study has been used to address the skin irritation caused by exposure to the test material. Brunt (2003c) was performed in accordance with OECD guideline 404 and EU Method B.4. Three rabbits were exposed to 0.5 ml of the test material for 4 hours; the site was them observed at intervals over a period of 14 days. The test material was determined to be moderately irritating, scoring a PDII of 3.2 out of 8. All observed effects were fully reversible, and skin appeared normal by day 14. The study was performed to standardised guidelines and performed to a good standard; the study was assigned a reliability score of 1 using the principles for assessing data quality as set out in Klimisch (1977).

Eye Irritation

A robust GLP compliant study has been used to address the eye irritation caused by exposure to the test material. Brunt (2003d) was performed in accordance with OECD guideline 405 and EU Method B.5. Three New Zealand White rabbits were exposed to 0.1 ml of the test material and observed over a 72 hour period. The test material caused sufficient pain when administered that a local anaesthetic was used. Under the conditions of the test moderate conjunctiva irritation was observed at 1 hour being scored 8 out of 20 according to the Draize scale (1977). This was fully reversible within 24 hours. No other ocular effects were noted over the 72 hour observation period. The study was performed to standardised guidelines and performed to a good standard; the study was assigned a reliability score of 1 using the principles for assessing data quality as set out in Klimisch (1977).


Effects on skin irritation/corrosion: moderately irritating

Justification for classification or non-classification

Skin Irritation

Under Regulation 1272/2008 the test material is classified as a should be classed as "Skin Irrit. 2" with assigned the hazard phrase "H315: Causes Irritation to the Skin" and signal word "Warning".

Eye Irritation

The eye irritation study indicates that the test material has no effect which requires classification. Therefore the material does not require classification in line with Regulation 1272/2008.

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