Registration Dossier

Administrative data

Description of key information

Skin irritation (OECD 404): not irritating
Eye irritation (OECD 405) 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 of potential of 1,2,3-Propanetriol, homopolymer, diisooctadecanoate (CAS# 63705-03-3) was investigate according to OECD Guideline 404 (Kaestner, 1998). The dorsal area of the trunk of three male Kleinrussen rabbits was exposed to unchanged test material for 4 hours. Skin reactions were assessed using the Draize scheme approx. 1, 24, 48, 72 hours and 7 days after removal of the test substance. The dermal application of the test substance did not result in edema in any of the animals tested at any observation time point. Very slight to slight erythema formation was observed in 3/4 animals at the 24 and 48 h reading time points. At the 72 h reading time point, slight and moderate erythema formation was observed in 2/4 animals. The effects were reversible in all animals within 7 days after the application of the test substance. The slight irritating effects seen in skin are below the hazard classification limit and therefore the substance is assumed as not irritating to skin.

 

Human Data      

A human patch test is available to evaluate the skin sensitising potential of 1,2,3-Propanetriol, homopolymer, diisooctadecanoate (CAS# 63705-03-3) was conducted according to Guidelines for the Assessment of Skin Tolerance of Potentially Irritant Cosmetic Ingredients (COLIPA, 1997) und under GCP conditions. 20 volunteers (females and males) with intact and healthy skin were included in the study (Krächter, 1997). Patches soaked with 70 µL of 20% test material were applied under occlusive conditions on the backs of the volunteers for 24 h. The reading time points were 6, 24, 48 and 72 h after removal of the test substance. Exposure to the test substance (20% AS) leads to slight erythema in 3/20 volunteers and slight scaling in 2/20 volunteers. The mean scores after 6, 24, 48 and 72 h were 0.15 for erythema and 0.25 for erythema, edema, scaling and fissure. The skin compatibility of the test substance in comparison to 1% Texapon N25 and 0.5% SDS was good. 

After 24 h exposure, the test substance (20% AS) was not irritating to human skin.

Under the experimental conditions described, it was concluded, that no evidence of skin irritation properties were seen after treatment with 1,2,3-Propanetriol, homopolymer, diisooctadecanoate (CAS# 63705-03-3).

 

Eye irritation

An acute eye irritation study was performed with 1,2,3-Propanetriol, homopolymer, diisooctadecanoate (CAS# 63705-03-3) according to OECD Guideline 405 (Kaestner, 1988).

0.1 mL of test substance was instilled in the conjuctival sac of one eye of 3 Kleinrussen rabbits. The animals were observed over 3 days. Eye irritation was scored by mean of the Draize scoring system at the following reading time points: 1, 6, 24, 48 and 72 h. The application of the test substance to one eye of each animal did not result in corneal opacity, iritis or swelling of the conjunctivae at any observation time point. Very slight redness of the conjunctivae was observed in 1/4 animals at the 24 h reading time point. The effect was reversible within 48 h after the application of the test substance. As the slight irritating effects are below the hazard classification limit, the substance is assumed as not irritating to the eye.

Under the experimental conditions described, it was concluded, that no evidence of eye irritation properties were seen after treatment with 1,2,3-Propanetriol, homopolymer, diisooctadecanoate (CAS# 63705-03-3).

Conclusions

Based on the available data there is no indication for skin irritation/corrosion of 1,2,3-Propanetriol, homopolymer, diisooctadecanoate (CAS# 63705-03-3).

Results of an eye irritation studies conducted with 1, 2,3-Propanetriol, homopolymer, diisooctadecanoate (CAS# 63705-03-3) did not show evidence of reversible eye irritation properties.


Justification for selection of skin irritation / corrosion endpoint:
There is only one study available.

Justification for selection of eye irritation endpoint:
There is only one study available.

Justification for classification or non-classification

The available data on skin/eye irritation potential 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.