Registration Dossier

Administrative data

Description of key information

non-skin irritant

non-eye irritant

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 the test substance was evaluated in the in-vitro EpiDerm™ reconstituted human epidermis, according to the OECD Guideline 439. EpiDerm™ tissues were exposed in triplicate to the test substance for 60 min. A positive (5 % SLS) and a negative (CMF-DPBS) control were also exposed in triplicate for 60 min. After the exposure period, the tissues were subjected to a post-treatment expression incubation at standard culture conditions for 42 hours. The cell viability after the post-exposure incubation was measured.

The mean % viability for the test substance was established to be 98.6 %. Based on the OECD 439 classification criteria the test substance can be considered as non-irritating.

Eye irritation

The potential of the test substance to induce opacity and permeability to fluorescein in an isolated bovine cornea was evaluated in the in vitro BCOP test according to the OECD Guideline 437. Bovine corneas were mounted in special holders and exposed to the test substance. Positive and negative controls run in parallel. The test and positive control corneas were exposed at 32 ± 1 °C for 10 min instead the negative control corneas for 30 min, after which the control or test treatments were removed and the corneas were rinsed and the opacity measurement was performed. The corneas were returned to the incubator for approximately 2 hrs after which a final measure of opacity was obtained. The posterior chamber was filled with fresh Complete MEM and 1 ml of 4 mg/ml fluorescein solution was added to the anterior chamber. The corneas were then incubated for 90 min at 32 ± 1 °C, after which aliquots were placed into their wells on a 96 -well plate and the optical density was determined at 490 nm (OD490).

The mean IVIS for the test substance was -1.2. Based on the classification criteria, the test substance is considered to be non-irritating to eyes.

Justification for classification or non-classification

The substance was assessed for its skin and eye irritation potential in two in-vitro studies.

Skin irritation

The substance did not induce a significant decrease in cell viability (quantified by formazan production). The cell viability was found to be 98.6 % after 60 min of exposure and 42 hours post-exposure. This value lays above the thresholds of irritation, i.e. < 50 % of negative control.

According to the CLP Regulation guidance, the classification criteria for the in-vitro skin corrosion/irritation studies are mentioned in the corresponding OECD test guideline. Based on the results of the in-vitro study and the recommendations of the OECD Guideline 439, no classification for skin irritation is proposed according to the CLP Regulation (EC) No.1272/2008.

Eye irritation

The substance has a mean in vitro irritation score (IVIS) of -1.2. Two classification systems proposed in two articles (Sina et al. 1995 and Vanparys et al. 1993) are reported in the study and suggest that the substance is not an eye irritant since it is lower even from the lowest score for classification (0 -25:mild irritant or 0 -3: non irritant). According to the CLP Regulation, negative results in the BCOP study can be used for classification purposes and no further testing is necessary. Based on the results of the in-vitro study no classification for serious eye damage/eye irritation according to the CLP Regulation (EC) No.1272/2008 is proposed.