Glycerides, C16-18

Endpoint summary

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Additional information

Skin irritation

A study was conducted to evaluate the skin irritation potential of ‘glycerides, C16-18’ (as fully hydrogenated cottonseed oil) in rabbits. In this study, a single occlusive patch containing 8.97% of the test substance was applied to nine rabbits. Sites were evaluated for erythema and edema at 2 and 24 h after exposure. The maximum possible irritation index (PII) score was 8. The PII of the formulation was found to be 0.06. Under the test conditions, the test substance tested at 8.97% was found to be non-irritating to rabbit skin (CIR, 2001 (1)).

A study was conducted to evaluate the skin irritation potential of ‘glycerides, C16-18’ (as fully hydrogenated cottonseed oil) in rabbits.In this study, a single occlusive patch containing 8% test substance was applied to nine rabbits. Sites were evaluated for erythema and edema at 2 h and 24 h after exposure. The maximum possible irritation index (PII) score was 8. The PII of the formulation was found to be 0. Under the test conditions, the constituent tested at 8% was found to be non-irritating to rabbit skin (CIR, 2001 (2)).

A study was conducted to evaluate the skin irritation potential of the constituent ‘glycerides, C16-18.’ (as fully hydrogenated cottonseed oil) in rabbits. In this study, a single occlusive patch containing 3.4% of the test substance was applied to nine rabbits. Sites were evaluated for erythema and edema at 2 h and 24 h after exposure. The maximum possible irritation index (PII) score was 8. The PII of the formulation was found to be 0.22. Under the test conditions, the test substance at 3.4% was found to be non-irritating to rabbit skin (CIR, 2001 (3)).

A study was conducted to evaluate the irritation potential of the constituent ‘palm oil’ in rabbits. In this study, the undiluted constituent was applied to the skin of 9 rabbits by means of a 24 h single-insult occlusive patch. At 2 h post application, five rabbits had an irritation score of 0 and the remaining four had a score of 0.5. At 24 h post application, one rabbit had a score of 0.5 and the remaining rabbits had a score of 0. The maximum possible irritation index (PII) score was 8. The PII of the test substance was found to be 0.22. Under the test conditions, the test substance was found to be non-irritating to rabbit skin (CTFA, 1978).

A study was conducted to evaluate the skin irritation potential of the constituent ‘glycerides, C8 -18 and C18 -unsatd.’ (as fully hydrogenated coconut oil) in rabbits. In this study, the undiluted substance was applied to the skin of 9 rabbits by means of a 24 h single-insult occlusive patch. No irritation was observed after 24 h of treatment (PII = 0.0). Under the test conditions, the substance was found to be non-irritating to rabbit skin (CIR, 1986 (2)).

A study was conducted to evaluate the skin irritation potential of ‘glycerides, C8-18 and C18-unsatd.’ (as fully hydrogenated coconut oil) in rabbits.

In this study, the undiluted substance was applied to the skin of 9 rabbits by means of a 24 h single-insult occlusive patch. Minimal irritation was observed after 24 h of treatment (PII = 0.11). Under the test conditions, the substance was found to be minimally irritating to rabbit skin (CIR, 1986 (1)).

A study was conducted to evaluate the irritation potential of ‘glycerides, C8-18 and C18-unsatd.’ (as coconut oil) in rabbits. In this study, the undiluted test substance was applied to the skin of 9 rabbits by means of a 24 h single-insult occlusive patch. No irritation was observed after 24 h of treatment (PII = 0).

Under the test conditions, the test substance was found to be non-irritating to rabbit skin (CIR, 1986).

Eye irritation

A study was conducted to determine the eye irritation potential of 3.4 -12.3 of the constituent 'glycerides, C16-18' (as fully hydrogenated cottonseed oil) in six rabbits. Cornea, iris, and conjunctiva were evaluated at Days 1, 2, 3, 4, and 7 after instillation. Under the test conditions, the substance was found to be mildly irritating to rabbit eye (CIR, 2001).

In an ocular irritation test, ‘glycerides, C8-18 and C18-unsatd.’ (as fully hydrogenated coconut oil) was instilled into eyes of six rabbits in a single dose without subsequent eye wash. Mild irritation (score: 6/110) was observed. The eyes appeared normal by the fourth day. Under the test conditions, the test substance was found to be mildly irritating to rabbit eyes (CIR, 1986).

A study was conducted to determine the ocular irritation potential of ‘glycerides, C8-18 and C18-unsatd.’ (as fully hydrogenated coconut oil). The substance was instilled into eyes of six rabbits in a single dose without subsequent eye wash. Minimal irritation (score: 1/110) was observed. The eyes appeared normal by the second day. Under the test conditions, the substance was found to be minimally irritating to rabbit eyes (CIR, 1986).

A study was conducted to determine the ocular irritation potential of ‘glycerides, C8-18 and C18 -unsatd.’ (as fully hydrogenated coconut oil). The substance was instilled into eyes of six rabbits in a single dose without subsequent eye wash. Minimal irritation (score: 2/110) was observed. The eyes appeared normal by the third day. Under the test conditions, the substance was found to be minimally irritating to rabbit eyes (CIR, 1986).

In an ocular irritation test, ‘glycerides, C8-18 and C18-unsatd.’ (as fully hydrogenated  coconut oil) was instilled into eyes of six rabbits in a single dose without subsequent eye wash. Minimal irritation (score: 2/110) was observed. The eyes appeared normal by the third day. Under the test conditions, the substance was found to be minimally irritating to rabbit eyes (CIR, 1986).

A study was conducted to determine the eye irritation potential of 'glycerides, C8 -18 and C18 -unsatd.’ (as coconut oil) according to an unspecified method. The substance was instilled into eyes of six rabbits in a single dose without subsequent eye wash. Minimal irritation (score: 2/110) was observed. The eyes appeared normal by the third day. Hence, under the test conditions, the substance was found to be minimally irritating to rabbit eyes (CIR, 1986).

A study was conducted to determine the eye irritation potential of ‘glycerides, C8 -18 and C18 -unsatd.’ (as coconut oil) according to an unspecified method. The undiluted substance was instilled into eyes of six rabbits in a single dose without subsequent eye wash. Minimal irritation (score: 1/110) was observed. The eyes appeared normal by the second day. Under the test conditions, the substance was found to be minimally irritating to rabbit eyes (CIR, 1986).

A study was conducted in rabbits to evaluate the eye irritation potential of ‘glycerides, C16 and C18 -unsatd. and C18 -unsatd. hydroxy’ (as castor oil).

0.5 mL of the undiluted substance was instilled into the eyes of five rabbits. The reactions were scored 18 to 24 h later. An injury grade of 1 (maximum score possible = 20) was reported for castor oil. Under the test conditions, the substance was found to be slightly irritating to rabbit eyes (CIR, 2007).

A study was conducted to determine the irritation potential of ‘glycerides, C16 and C18 -unsatd. and C18-unsatd. hydroxy’ (as castor oil) on the rabbit eyes was assessed according to the official French methods. Following the instillation of undiluted test substance (no ocular rinsing), no corneal involvement was found. However, slight congestion of the iris and conjunctiva was observed. Under test conditions, the substance was found to be slightly irritating to rabbit eyes (CIR, 2007).

A study was conducted to determine the ocular irritation potential of the undiluted  ‘glycerides, C16 -18 and C18 -unsatd.’ (as palm oil). The substance was instilled into eyes of six rabbits in a single dose without subsequent eye wash. Ocular irritation reactions were scored using the Draize scale (0 -110). Total ocular irritation score was 3 on Day 1 post instillation and 1 on Day 2 post instillation. The eyes appeared normal by the third day. Under the test conditions, the undiluted substance was found to be minimally irritating to rabbit eyes (CTFA, 1978).

A study was conducted to determine the ocular irritation potential of 2% of 'glycerides, C16 -18 and C18 -unsatd.’ (as palm oil). The substance was instilled into eyes of six rabbits in a single dose without subsequent eye wash. Ocular irritation reactions were scored using Draize scale (0 -110). Total ocular irritation score was 1 after 24 h of instillation. The eyes appeared normal by the second day. Under the test conditions, 2% of thesubstance was found to be minimally irritating to rabbit eyes (CIR, 2000).

Justification for classification or non-classification

Eye and/or skin irritation studies were conducted with ‘glycerides, C16-18 (SDA Reporting Number: 19-001-00)’ and other structurally similar substances of the same read-across category. Overall, this group of substances is assessed to be not to mildly irritating to skin and eyes, respectively.

Exposure to aerosolised or powder forms of this substance via the inhalation route and consequent respiratory irritation is not expected given the implementation of appropriate risk management measures (e.g. dust filter mask) and its low vapour pressure (< 1.33 x 10^-8Pa at 20°C).

Based on the above information, this substance does not require to be classified for irritation properties according to EU CLP Regulation (EC) 1272/2008.