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Description of key information

All available studies on skin and eye irritation showed no irritating potential of the category members.
Studies on acute skin irritation were available for (CAS No.) 3687-46-5.
Key, Dufour, 1994, Stearinerie, rabbit, RL2 - not irritating.
Study on acute skin irritation was available for (CAS No.) 95912-88-2.
key, Kästner, 1987, Cognis, skin, RL2 - not irritating.
Study on acute eye irritation was available for (CAS No.) 95912-88-2.
Key, Kastner, 1987, Cognis, rabbit, RL2 – 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)

Additional information

All available experimental data on skin and eye irritation indicate that the members of this category are not irritant or corrosive.

Skin Irritation:

In a reliable study Decyl oleate (CAS No. 3687-46-5) was tested for its skin irritation potential according to OECD Guideline 404 (Dufour, 1994). The shaved skin of three malerabbits was exposed to unchanged test material for 4 hours under semi-occlusive conditions. The rabbits were observed for 5 days. Skin reactions were assessed according to Directive 67/548/CEE approx. 1, 24, 48 and 72 hours as well as 5 days after removal of the test substance.The exposure period of 4 hours caused only slight erythema in all animals, however this was fully reversed within day 5. Also a slight edema was seen in one of the animals which were fully reversed within day 5.

Fatty acids, C16-18, C12-18-alkyl esters (CAS No.95912-87-1) was tested for its skin irritation potential according to OECD Guideline 404 (Kästner, 1987). The shaved skin of 5 rabbits (Kleinrusse, Chbb: HM) was exposed to 0.5mL of unchanged test material for 4 hours under occlusive conditions. The rabbits were observed for 7 days. Skin reactions were assessed according to Directive 67/548/CEE approx. 1, 24, 48 and 72 hours as well as 7 days after removal of the test substance.The exposure period of 4 hours caused only slight erythema in the 4 animals tested, however this was fully reversed within day 7. Also a slight edema was seen in two of the animals which were fully reversed within day 7.

Decyl oleate (CAS No. 3687-46-5) was patch tested in rabbit using a test plaster, which was applied to the back of the animals for 6 hour exposure (Potokar, 1970). After removing the plaster, a slight redness was seen at the application site, the effect was fully reversible within 48 hours. This study was disregarded as only a short abstract on method and results was available.

The undiluted test substance (Decyl oleate (CAS No. 3687-46-5)) in olive oil was applied to the back skin of New-Zealand rabbits every 30 seconds for 30 minutes(Potokar, 1970).The test material was gently rubbed into the skin using glass-rod. No signs of irritation were seen. This study was disregarded as only a short abstract on method and results was available.

The undiluted test substance (Decyl oleate (CAS No. 3687-46-5)) and a 50% solution of the test material in olive oil was analysed for its skin irritation potential, in 5 male Wistar rats by daily application of small amounts onto the shaved back skin for a duration of 14 days.(Potokar, 1970). The undiluted test material caused slight eschar formation at the treated sites of the animals after 5 applications, whereas the 50% dilution did not cause any signs of irritation. This study was disregarded as only a short abstract on method and results was available.

To evaluate the skin irritation potential of Decyl oleate (CAS No. 3687 -46 -5) a 50% solution of the test material in olive oil was applied daily during a 14 day period onto the skin of five nude mice. During treatment and thereafter no signs of irritation were seen (Potokar, 1970).This study was disregarded as only a short abstract on method and results was available.

Eye Irritation:

Fatty acids, C16-18, isotridecyl esters (CAS No. 95912-88-2) was examined for its eye irritation potential in a study performed equivalent to OECD Guideline 405 (Kästner, 1987).0.1 mL undiluted test substance was instilled to the right eye of 4 rabbits (Kleinrusse, Chbb: HM). 1, 6, 24, 48 and 72 hours after instillation examination of the treated eyes revealed no ocular lesions. Thus, based on the study results, the test substance showed no eye irritating potential.

Decyl octadec-9-enoate (CAS No. 3687-46-5) was examined for its eye irritation potential in a study performed equivalent to OECD Guideline 405 (Potokar, 1970). 50% solution test substance in 50% olive oil was instilled to the right eye of 3 rabbits (New Zealand). 2, 6, 24, 48 hours after instillation examination of the treated eyes revealed no ocular lesions. Thus, based on the study results, the test substance showed no eye irritating potential.

Respiratory Irritation:

No data was available to access the respiratory irritation potential of the LCAEs.

Justification for classification or non-classification

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

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