Heptadecanol, branched and linear

Endpoint summary

Description of key information

Skin irritation: EU: R38 (irritating); CLP: not irritating (BASF, 2007)
Eye irritation: EU: not irritating, CLP: not irritating (BASF, 2007)

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

Skin irritation:

The primary skin irritation potential of Heptadecanol N was investigated according to OECD test guideline no. 404 (BASF, 2007). The test item was applied by topical semi-occlusive application of 0.5 mL to the intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours, as weil as 7, 10 and 14 days after removal of the dressing. The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythemaleschar grades and for oedema grades, separately. The mean erythemaleschar score was 2.00 for each of the three animals and the mean oedema score was 1.00 for each of the three animals. The application of Heptadecanol N to the skin resulted in mild to moderate signs of irritation including erythema, oedema and scaling. At the end of the two week observation period, very slight erythema and scaling were still present in two animals, respectively. The test item caused no staining of the treated skin. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed. At the end of the two-week observation period, very slight erythema or scaling was still present in one animal, respectively. Thus, the test item induced moderate skin irritation which was not fully reversible during the observation period.

Eye irritation:

The primary eye irritation potential of Heptadecanol N was investigated according to OECD

test guideline no. 405 (BASF, 2007). The test item was applied by instillation of 0.1 mL into the left eye of

each of three young adult New Zealand White rabbits. Scoring of irritation effects was

performed approximately 1, 24, 48 and 72 hours after test item instillation.

The mean Score was calculated across 3 scoring times (24, 48 and 72 hours after instillation)

for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae,

separately. The individual mean scores for corneal opacity and iris were 0.00 for all three

animals. The individual mean scores for the conjunctivae were 0.00, 0.33 and 0.33 for

reddening, respectively, and 0.00 for chemosis for each of the three animals.

The instillation of Heptadecanol N into the eye resulted in mild, early-onset and transient

ocular changes, such as reddening of the conjunctivae and sclerae, and chemosis. These

effects were reversible and were no longer evident 48 hours after treatment. No abnormal

findings were observed in the Cornea or iris of any animal at any of the examinations. No

corrosion was observed at any of the measuring intervals. No staining of the treated eyes by

the test item was observed and no clinical signs were observed.

Thus, the test item did not induce significant or irreversible damage to the rabbit eye.

Justification for classification or non-classification

The test item showed some irritation to the skin but not to the eye. The skin irritation leads to an R38 classification according to EU Directive 67/548/EC but there is no need to classify for skin irritation according to the CLP Regulation 1272/2008/EC.

Based on the observed effects on the rabbit eye, there is no need for classification according to the EU Directive 67/548/EC and according to the CLP Regulation 1272/2008/EC.