Registration Dossier

Administrative data

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

The skin irritation potential of 1,2,3-propanetriyl triisooctadecanoate was investigated in a GLP-conform study performed according to OECD 404 (Saboureau, 1989). The 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, 6, 7 and 8 days after removal of the dressing. Very slight erythema was observed in 2/3 animals 1 h after patch removal, which persisted until Day 5 and 6, respectively. No edema was noted in any animal at any reading time point. Very slight loss of skin elasticity and dryness were observed. No signs of systemic toxicity were seen during the study. The individual mean erythema scores over the 24, 48 and 72 h reading time points were 1, 1, 0, and the edema scores were 0 for 3/3 animals. Therefore, the test substance is considered to be non-irritating to the skin.

A study assessing the skin irritation potential of 1,2,3-propanetriyl triisooctadecanoate was performed according to OECD guideline 404 under GLP-conditions (Jones, 1987). 0.5 mL of the test substance was applied for 4 h to the shaved skin of 6 New Zealand White rabbits under semiocclusive conditions. The untreated skin site of the animals served as the control. The skin reactions (erythema and oedema) were scored 1, 24, 48 and 72 h after treatment ended. One hour after treatment ended, well-defined erythema (score 2) and very slight oedema (score 1) were observed in 1/6 animals. Very slight erythema was observed in 5/6 rabbits; out of these, 3 also showed very slight oedema. In 2/6 rabbits, the dermal reactions extended 3-4 cm beyond the test sites at the 1-hour reading time point. 1/6 animals exhibited very slight erythema at the 24-hour reading time point, which had cleared completely within 48 hours after patch removal. For the remaining 5 animals, the effects had reversed completely by the 24-hour reading time point. The individual mean erythema scores over 24, 48 and 72 h after exposure ended were 0.33,0,0,0,0,0 and the edema scores were 0 for 6/6 animals. In conclusion, the test substance is considered to be non-irritating to the skin.

The skin irritation potential of 1,2,3-propanetriyl triisooctadecanoate was investigated in a GLP-conform study according to OECD guideline 404 (Bouffechoux, 1996). Only a short summary of the results was available. An unknown amount of test substance was applied for an undefined length of time to the skin of 3 male 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, and 7 days after removal of the dressing. Well-defined erythema was observed in 3/3 animals at 1 and 24 h post-application, and slight erythema persisted in 2/3 animals until the 48 h-reading time point. The erythema had cleared completely by the 72 -hour reading time point. No oedema was observed in any animal at any time point. The test substance is considered to be non-irritating to the skin.

 

Eye irritation

An eye irritation study was performed with 1,2,3-propanetriyl triisooctadecanoate according to OECD guideline 405 and under conditions of GLP (Saboureau, 1989). The undiluted test substance (0.1 mL) was instilled into one eye of 3 New Zealand White rabbits each. 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 application. Slight redness (enanthema ) together with lacrimation was observed in all animals at 1 hour post-instillation. The redness persisted in all animals at the 24-hour reading time point, but was fully reversible within 48 h. Only one animal showed slight chemosis at the 1 -hour 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, respectively. The mean score for conjunctivae over 24, 48, and 72 h was 0.33, 0.33, 0.33 for the 3 animals.In conclusion, the test substance was not considered as eye irritant.

The eye irritation potential of 1,2,3-propanetriyl triisooctadecanoate was investigated in a GLP-conform study according to OECD guideline 405 (Jones, 1987). The undiluted test substance (0.1 mL) was instilled into one eye of 6 New Zealand White rabbits each. 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 application. One hour after treatment, minimal to slight conjunctival irritation (score 1-2) was observed in the treated eyes of all animals. Only a single animal showed minimal inflammation of the conjunctivae after 24 h. The treated eyes of all other animals remained without conjunctival reactions at the same time point. No effects on conjunctivae were noted at the 48 - and 72 -hour reading time points. No corneal damage or iridial effects were noted in any animal during the study period.The test substance was not considered to be eye irritant.

The eye irritation potential of 1,2,3-propanetriyl triisooctadecanoate was investigated in a GLP-conform study according to OECD guideline 405 (Bouffechoux, 1996). Only a short summary of the results was available. The undiluted test substance (unknown amount) was instilled into one eye of 3 New Zealand White rabbits each. 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 application. 1 hour post-installation, 2/3 animals had a conjunctivae score of 3, indicating diffuse beefy redness, while 1/3 animals had a conjunctivae score of 2 (diffuse, crimson colour). No separate chemosis scores were given, however, it is assumed that only redness was scored. 1/3 animals had a conjunctivae score of 1 at the 24-hour reading time point, which had cleared within 48 hours after instillation. No effects on cornea or iris were noted in any animals at any time point.The test substance was considered not to be eye irritant.


Justification for selection of skin irritation / corrosion endpoint:
The selected study is the most adequate and reliable study based on overall quality assessment (refer to the endpoint discussion for further details).

Justification for selection of eye irritation endpoint:
The selected study is the most adequate and reliable study based on overall quality assessment (refer to the endpoint discussion for further details).

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.