Dioctyl carbonate

Endpoint summary

Description of key information

Skin irritation:
Key study:
The primary skin irritant effect of the test item was investigated in accordance with the OECD Guideline No. 404  and EU method B.4.Very slight skin reactions were observed among the rabbits. These reactions were not complete reversible in one animal 21 days after application of the test article.
Supporting study:
In this study the potential of the test item to induce skin irritations was assessed in vitro using the reconstructed human epidermal model EpiDermTM (EPI-200). The results obtained from the test indicated a mean viability greater than 50 after total 60 min incubation time and thus the test item is considered to be non-irritant.
Study results of skin irritation tests with humans (24 -h patch test) are reported in IUCLID section 7.10.5. The results revealed that the test item showed a good skin compatibility and did not lead to any skin reactions, thus, the test item is considered to be not irritating. Theses human data proved the results obtained from the animal studies.
Eye irritation:
Key study:
The eye irritation properties of the test item were evaluated using an in vivo test in accordance with OECD guideline 405 and EU method B.5. Slight signs of irritation were observed on the treated eyes, but these were not subject for classification.
Supporting study:
The eye irritation properties of the test item were evaluated using an in vitro HET-CAM test. According to this test, it is predicted that the test item does not  cause strong eye irritation.

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:

Key study:

The primary skin irritant effect of the test item was investigated in accordance with the OECD Guideline No. 404 and EU method B.4. Three female albino rabbits were exposed to the test article at two skin sites on the back. After 4 hours of exposure the test article was removed and the skin was examined 1, 24, 48 and 72 hours as well as 7, 14 and 21 days after termination of exposure. Very slight skin reactions were observed among the rabbits. The mean individual erythema scores were 0.17, 1.00, 1.00, respectively. The mean individual oedema scores were 0.00, 0.00, 0.33, respectively.These reactions were not complete reversible in one animal 21 days after application of the test article, but this was not subject for classification.

Supporting study:

The potential of the test item to induce skin irritations was assessed in vitro using the reconstructed human epidermal model EpiDermTM (EPI-200). The results obtained from the test indicated a mean viability greater than 50 after total 60 min incubation time and thus the test item is considered to be non-irritant.

Study results of skin irritation tests with humans (24 -h patch test) are reported in IUCLID section 7.10.5. The results revealed that the test item showed a good skin compatibility and did not lead to any skin reactions, thus, the test item is considered to be not irritating. Theses human data proved the results obtained from the animal studies.

Eye irritation:

Key study:

The eye irritation properties of the test item were evaluated using an in vivo test in accordance with OECD guideline 405 and EU method B.5. Three female albino rabbits were exposed to 0.1 mL of the test article in the left eye. The eyes were examined and the changes were graded according to a numerical scale one hour, 24, 48 and 72 hours after dosing. Slight signs of irritation were observed on the treated eyes. After 24 hours animal no. 1 and no. 2 showed some conjunctival vessels definitely injected. Some conjunctival vessels definitely injected and some swelling above normal was observed in animal no. 3. After 48 hours animal no. 1 showed some conjunctival vessels definitely injected. Animal no. 2 and no. 3 did not show any signs of eye irritation. After 72 hours all animals were free of any signs of eye irritation.

Supporting study:

The eye irritation properties of the test item was investigated in the in vitro HET-CAM test with incubated hen eggs. The HET-CAM Test is an alternative in vitro method for testing of severe eye/mucous membrane damage using the chorionallantoic membrane of fertilized, incubated hen eggs. Due to animal welfare reasons, the potential of severe irritation is determined in the HET-CAM in vitro system before deciding on a possible study in the rabbit as suggested in OECD Guideline 405.

The irritation potential of the undiluted test item is markedly lower than the irritation potential of the reference item Texapon ASV. Therefore the test item is considered to be not severly irritant.

Justification for classification or non-classification

Based on skin irritation data available, the test item is not classified as skin irritating according to Regulation No (EC) 1272/2008 (CLP) and Directive 67/548/EEC (DSD).

Based on eye irritation data available, the test item is not classified as eye irritating according to Regulation No (EC) 1272/2008 (CLP) and Directive 67/548/EEC (DSD).