Registration Dossier

Administrative data

Description of key information

SKIN: It can be stated that in this study and under the experimental conditions reported, the test item FAT 40840/A TE is non corrosive to 
skin.
EYE: The test item FAT 40840/A TE caused opacity and permeability of the corneas compared with the results of the negative control. The calculated in vitro score was 11.70 and therefore, the test item was classified as mild eye irritant.
the test item FAT 40840/A TE is considered to be a mild eye irritant.

Key value for chemical safety assessment

Additional information

Skin

In Vitro

After treatment with the test item FAT 40840/A TE the relative absorbance values were

decreased to 86.6% after 3 minutes treatment. After 1 hour treatment relative absorbance

values were reduced to 74.8%. Both values are well above the threshold for corrosivity

(50% for 3 minutes treatment and 15% for 1 hour treatment). Therefore, the test item is

not considered corrosive.

In Vivo

The primary skin irritation potential of FAT 40840/A TE was investigated according to OECD test guideline no. 404 (semi-occlusive application, young adult New Zealand White rabbits). The duration of treatment was four hours, observation period 1h-10d. Marked red staining produced by the test item (red dye) was observed on the skin of all animals one hour after treatment, which persited as slight up to the72-hour reading or up to 7 days after treatment. Due to this staining no assessment of erythema formation could be made 1 hour after the treatment. From 24 hours after the treatment onwards, the intensity of the staining was reduced and a full assessment of skin reactions was possible. Neither erythemas nor any other skin reactions were observed at any of the observation times. Therefore, the individual score for erythema/eschar and oedema for each of the three animals was 0 at any of the time points where an assessment was possible. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed. Thus, the test item did not induce significant or irreversible damage to the skin.

Eye

The test item FAT 40840/A TE caused opacity and permeability of the corneas compared with the results of the negative control. The calculated in vitro score was 11.70 and therefore, the test item was classified as mild eye irritant ( Score 3.1 -25 = mild eye irritant).

In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item FAT 40840/A TE is considered to be a mild eye irritant.

Justification for classification or non-classification

Skin

In vitro

In the present study the test item FAT 40840/A TE was tested for its potential to induce skin corrosion in a human skin model. The test allows the discrimination between corrosive and non-corrosive chemical substances and mixtures. It does not provide information on skin irritation, nor does it allow the subcategorisation of corrosive substances according to GHS.

In Vivo

Based upon the referred classification criteria (Commission Directive 2001/59/EC of August 2001), FAT 40840/A TE is considered to be “not irritating” to rabbit skin.

Eye

FAT 40840/A E is a mild eye irritant but is not classified since the result of the study lies outside the classification criteria