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Administrative data

Description of key information

Studies on skin irritation/corrosion were available for the following category members (CAS No.): 31566-31-1, 67701-26-2, 67701-33-1, 73398-61-5, 85251-77-0, 91052-54-9, 91744-13-7. No skin irritation potential was observed in any of these studies. 
Studies on eye irritation were available for the following category members (CAS No.): 67701-26-2, 67701-33-1, 73398-61-5, 8001-78-3, 85251-77-0, 91744-13-7. No eye irritation potential was observed in any of these studies.

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:

Stearic acid, monoester with glycerol (CAS No. 31566-31-1) was tested for its skin irritation potential according to OECD Guideline 404 (Dufour, 1993): Three New Zealand White rabbits were exposed to 0.5 mL (5 g of the solid test substance was mixed with 3.2 mL vaseline to a final volume of 6.7 mL) test material (concentration of 75%) for 4 hours under semi-occlusive conditions. The rabbits were observed for 72 hours. Skin reactions were assessed using the Draize scheme 24, 48 and 72 hours after removal of the test substance. No erythema and no oedema occurred in any of the tested animals at any observation interval.

 

C12-C18 trialkyl glyceride (CAS No. 67701-26-2) was tested for its skin irritation potential according to EPA OPP 81-5 (Guest, 1988): Six New Zealand White rabbits were exposed to 0.5 mL of the waxy solid test material (warmed to approx. 40 ºC and applied as a liquid to the skin) for 4 hours under semi-occlusive conditions. The rabbits were observed for 72 hours. Skin reactions were assessed using the Draize scheme 24, 48 and 72 hours after removal of the test substance. Slight erythema was observed in 3 out of 6 animals 24 and 48 hours after patch removal, which was fully reversible within 72 hours. In the other animals no erythema was observed. No oedema occurred in any of the tested animals.

 

Glycerides, C14-18 mono- and di- (CAS No. 67701-33-1) was tested for its skin irritation potential according to OECD Guideline 404 (Gomond, 2000): Three New Zealand White rabbits were exposed to 0.5 g of the crunched test substance in mineral oil for 4 hours under semi-occlusive conditions. The rabbits were observed for 72 hours. Skin reactions were assessed using the Draize scheme 24, 48 and 72 hours after removal of the test substance. Slight erythema was observed in two animals 24 and 48 hours after patch removal, which was fully reversible within 72 hours. In the third animal no erythema was observed. No oedema occurred in any of the tested animals.

 

Glycerides, mixed decanoyl and octanoyl (CAS No. 73398-61-5) was tested for its skin irritation potential according to EPA OPP 81 -5 (Jones, 1988): Six New Zealand White rabbits were exposed to 0.5 mL of the liquid test substance for 4 hours under semi-occlusive conditions. The rabbits were observed for 72 hours. Skin reactions were assessed using the Draize scheme 24, 48 and 72 hours after removal of the test substance. No erythema and no oedema occurred in any of the tested animals at any observation interval.

 

Glycerides, C16-18 mono- and di- (CAS No. 85251-77-0) was tested for its skin irritation potential according to OECD Guideline 404 (Ruat, 1999): Six New Zealand White rabbits were exposed for 4 hours to 0.5 g of the solid test substance using liquid paraffin as vehicle to form a paste for skin exposure under semi-occlusive conditions. The rabbits were observed for 7 days. Skin reactions were assessed using the Draize scheme 24, 48 and 72 hours after removal of the test substance. Slight erythema occurred in 4 out of 6 animals 24, 48 and 72 hours after patch removal, which was fully reversible within 7 days. In the other two animals no erythema occurred. No oedema occurred in any of the tested animals at any observation time point.

 

Glycerides, C16-18 mono-, di- and tri- (CAS No. 91052-54-9) was tested for its skin irritation potential according to EPA OPP 81-5 (Jones, 1988): Six New Zealand White rabbits were exposed to 0.5 g of the solid test substance moistened with 0.5 mL of distilled water for 4 hours under semi-occlusive conditions. The rabbits were observed for 72 hours. Skin reactions were assessed using the Draize scheme 24, 48 and 72 hours after removal of the test substance. No erythema and no oedema occurred in any of the tested animals at any observation time point.

 

Glycerides, C14-18 and C16-22-unsatd. mono- and di- (CAS No. 91744-13-7) was tested according to OECD Guideline 404 (Steiling, 1990): Three New Zealand White rabbits were exposed to 0.5 mL of the liquid test substance for 4 hours under semi-occlusive conditions. The rabbits were observed for 7 days. Skin reactions were assessed using the Draize scheme 24, 48 and 72 hours after removal of the test substance. Slight erythema occurred in two out of 3 tested animals, which was fully reversible within 7 days. Slight oedema occurred in one out of 3 tested animals, which was fully reversible within 7 days. Based on these study results according to EU classification criteria for skin irritation no classification is required.

 

Eye irritation:

Glycerides, C12-18 (CAS No. 67701-26-2) was tested for its eye irritation potential according to EPA OPP 81-4 (Jones, 1988): 0.1 mL (approx. 97 mg) of the waxy solid test substance was warmed until molten and instilled into the conjunctival sac of one eye of six New Zealand White rabbits. The animals were observed for 72 hours. Irritation was scored 24, 48 and 72 hours after instillation according to the method of Draize. Slight redness of conjunctivae occurred 2 out of 6 tested animals, which was fully reversible within 48 hours.

 

Glycerides, C14-18 mono- and di- (CAS No. 67701 -33 -1) was tested for its eye irritation potential according to OECD Guideline 405 (Gomond, 2000): 0.1 g of the solid test material was ground to a fine dust using a pestle in a mortar and instilled into the conjunctival sac of one eye of three New Zealand White rabbits. The animals were observed for 72 hours. Irritation was scored 24, 48 and 72 hours after instillation according to the method of Draize. Slight redness of conjunctivae occurred in all three tested animals, which was fully reversible within 72 hours. Slight chemosis occurred in 2 out of 3 tested animals, which was fully reversible within 48 hours.

 

Glycerides, mixed decanoyl and octanoyl (CAS No. 73398 -61 -5) was tested for its eye irritation potential according to EPA OPP 81-4 (Sasol, 1988): 0.1 mL of the liquid test material was instilled into the conjunctival sac of one eye of six New Zealand White rabbits. The animals were observed for 72 hours. Irritation was scored 24, 48 and 72 hours after instillation according to the method of Draize. Slight redness of conjunctivae and slight chemosis occurred in one out of six tested animals, which was fully reversible within 48 hours. No other eye irritation was observed in any tested animal at any observation time point.

 

Glycerides, C16-18 mono- and di- (CAS No. 85251-77-0) was tested for its eye irritation potential according to OECD Guideline 405 (Ruat, 1999): 0.1 mL (approx. 54 mg) of the solid test substance was crushed to a fine powder and instilled into the conjunctival sac of one eye of six New Zealand White rabbits. The animals were observed for 72 hours. Irritation was scored 24, 48 and 72 hours after instillation according to the method of Draize.

Slight iritis was observed in one out of six tested animals at 24 and 48 hours after instillation, which was fully reversible within 72 hours. No other eye irritation was observed in any tested animal at any observation time point.

 

Glycerides, C14-18 and C16-22-unsatd. mono- and di- (CAS No. 91744-13-7) was tested for its eye irritation potential according to OECD Guideline 405 (Steiling, 1990): 0.1 mL of the liquid test material was instilled into the conjunctival sac of one eye of three New Zealand White rabbits. 24 hours after instillation the eyes were washed with hand warm water. The animals were observed for 72 hours. Irritation was scored 24, 48 and 72 hours after instillation according to the method of Draize. No eye irritation was observed in any tested animal at any observation time point.

 

Castor oil, hydrogenated (CAS No. 8001 -78 -3) was tested for its eye irritation potential similar to OECD Guideline 405 (Kästner, 1981): 0.1 mL of the test material was instilled into the conjunctival sac of one eye of four New Zealand White rabbits. The animals were observed for 72 hours. Irritation was scored 24, 48 and 72 hours after instillation according to the method of Draize. Slight changes were scored for conjunctivae and chemosis, which were described to be fully reversible within 48 hours.

 

 

Justification for classification or non-classification

According to DSD (67/548/EEC) or CLP (1272/2008/EC) classification criteria for irritation/corrosion, no classification is required.