Isooctadecanoic acid, monoester with glycerol

Endpoint summary

Description of key information

Skin, rabbit: not irritating
Eye, rabbit: not irritating

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

CAS No. 66085-00-5

A skin irritation study was conducted with Glycerol monoisostearate according to OECD guideline 404 and in compliance with GLP (Saboureau, 1989). The undiluted test substance (0.5 mL) was applied for 4 h to the shaved skin of 3 New Zealand White rabbits under semiocclusive conditions. The untreated site of the animals served as control. The scoring of skin reactions (erythema and edema) was performed 1, 24, 48 and 72 h as well as 5 days after removal of the dressing. Slight erythema was observed in 2/3 animals at 1, 24 and 48 h after patch removal, which was fully reversible within 72 h. In one of these animals, very slight edema was observed at the 1 h reading only. Well-defined erythema was observed in the third animal at 1, 24 and 48 h post-application, which decreased to slight erythema at 72 h reading and was fully reversible within the 5-day observation period. In the same animal, very slight edema was seen at the 1, 24 and 48 h reading time points, which was fully reversible within 72 h. Slight changes in cutaneous structure were also observed, which were only slowly reversible. During the study period, no signs of systemic toxicity were observed in the animals. The mean erythema and edema scores over 24, 48 and 72 h were 0.7/1.7/0.7 and 0/0.7/0 for the 3 individual animals, respectively. Therefore, the test substance was considered to be non-irritating to the skin.

In a study performed according to the guideline ‘Journal Officiel de la République Francaise 21/4/71 and 5/6/73’, 0.5 mL of a 50% solution of the test substance in lanoline was applied to the shaved skin of 6 New Zealand rabbits (Guillot, 1977). The treated site was covered with an occlusive patch for 23 hours. The scoring of skin reactions (erythema and edema) was performed 24 and 72 h after removal of the dressing. Very slight erythema was noted in 1/6 animals at the 24-hour reading time point, which had cleared within 72 hours. The mean erythema scores over 24 and 72 h were 0.67/0/0/0/0/0 for the 6 individual animals, respectively. Therefore, the test substance was considered to be non-irritating to the skin.

Eye irritation

CAS No. 66085-00-5

An eye irritation study was performed with Glycerol monoisostearate according to OECD guideline 405 and under GLP-conditions (Saboureau, 1989). The undiluted test substance (0.1 mL) was instilled into one eye each of 3 New Zealand White rabbits. The other eye remained untreated and served as control. Examination and scoring of effects on the eyes was performed at intervals of 1, 24, 48 and 72 h after test substance instillation. Slight conjunctival enanthema, slight chemosis and profuse lacrimation were observed in all 3 animals 1 h post-instillation. Slight enanthema was still observed in 2/3 animals at the 24 h reading time point, but was fully reversible within 48 h. Chemosis and lacrimation were no longer observed from the 24 h reading time point. No cornea or iris lesions were observed in any animal at any time point. No further local or systemic toxic effects were observed. The mean cornea, iris and chemosis scores over 24, 48, and 72 h were 0 for all 3 animals. The mean score for conjunctivae over 24, 48, and 72 h was 0.22 for all animals, respectively.Therefore, the test substance was not considered to be an eye irritant.

In a study performed according to the guideline ‘Journal Officiel de la République Francaise 21/4/71 and 5/6/73’ 0.1 mL of the undiluted test substance (0.1 mL) was instilled into one eye each of 6 New Zealand White rabbits (Guillot, 1977). The other eye remained untreated and served as control. Examination and scoring of effects on the eyes was performed at intervals of 1, 24, 48, 72 and 96 h, and 7 days after test substance instillation. At 1 h post-instillation, 4/6 animals had slight (score 1) and 2/6 animals distinct conjunctival redness (score 2), respectively. At the 24-hour reading time point, all 6 animals were scored 2, while at 48 h, 3/6 were scored 1. The conjunctival redness had cleared completely within 72 hours. Chemosis above normal (score 1) was observed in 5/6 animals at 1 h and 24 h post-instillation. The effects had cleared by the 48-hour reading time point. Circumcorneal injection was noted in 1/6 animals at the 24 hour reading time point only.The test substance was not considered to be an eye irritant. 

Justification for selection of skin irritation / corrosion endpoint:
The key study was selected.

Justification for selection of eye irritation endpoint:
The key study was selected.

Justification for classification or non-classification

The available data on skin and eye irritation do not meet the classification criteria according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.