Decahydro-2-naphthyl acetate

Endpoint summary

Description of key information

Skin irritation potential was evaluated in the EpiDerm™ Reconstructed Human Epidermis Model (OECD 439). Following 60 minute exposure to the undiluted test item, the mean relative absorbance values indicative of cell viability were unaltered (100.0% viability; threshold for irritancy: ≤ 50%), consequently the test item was not considered irritating to the skin.

Adhering to OECD TG 405 and GLP, an in vivo rabbit eye irritation study demonstrated mean cornea opacity, iris lesion, conjunctiva redness and conjunctiva oedema (chemosis) score of 0.0, 0.0, 1.0 and 0.7, respectively. All signs of irritation were reversed within 7 days and the test substance is not considered to be irritating to the eye

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 of the test item was evaluated with the EpiDerm™ Reconstructed Human Epidermis Model (2016). Cell viability of the multi-layered tissue culture of highly differentiated epidermal keratinocytes topically exposed to the test substance was evaluated using the MTT assay, which measures the conversion of 3-(4,5-dimethylthiazole-2-yl)-2,5-diphenyl-tetrazoliumbromide (MTT) into a blue formazan salt. Undiluted test item was applied to the EpiDerm™ tissue for 60 minutes, alongside a negative and positive control. The mean relative absorbance value of the test item, corresponding to the cell viability did not decrease (100.0%; threshold for irritancy: ≤ 50%), consequently the test item was not irritant to skin. The test item passed the MTT and Colour Interference pre-tests. Conducted according to OECD Test Guideline 439 and GLP, the study is considered to be reliable without restriction (Klimisch 1) and sufficient to fulfil the REACH Annex VII information requirement.

Eye irritation of the test item was tested in four female albino rabbits. An undiluted volume (0.1 mL) of the test item was administered to one eye, whilst the other eye served as a control (2000). Effects on the cornea, iris and conjunctiva were recorded at 1, 24, 48 and 72 hours and 7 days after application. The mean scores of cornea opacity, iris lesion, conjunctiva redness and conjunctiva oedema (chemosis) were 0.0, 0.0, 1.0 and 0.7, respectively. All animals were free of any signs of eye irritation after 7 days. According to the directive of the EEC commission 93/21/EEC (4 May 1993), the test item should not be classified as eye irritating. Conducted according to OECD Guideline 405 and EU Method B.5 and GLP, the study was considered to be reliable without restriction (Klimisch 1).

Justification for classification or non-classification

Two reliable (Klimisch 1) and GLP compliant studies are available to inform the irritation / corrosion classification of Decahydro-2-naphthyl acetate (2000; 2016). In the eye irritation study, effects of the test item on 4 rabbits were reversible within 7 days. Individual mean scores were not ≥ 1 for corneal opacity and iritis and not ≥ 2 for conjunctival redness and oedema in at least 3 of 4 animals. Thus, according to the "Guidance on the Application of the CLP Criteria" (ECHA 2015), the test item should not be classified as an eye irritant. 

According to UN GHS and EU CLP Category 2, a substance is considered to be irritant to skin if the tissue viability after exposure and post-treatment incubation is ≤ 50%. In the EpiDerm skin irritation study, the mean relative absorbance value of the test item, corresponding to the cell viability, was 100%. Therefore, test item should not be classified as a skin irritant.