Registration Dossier

Administrative data

Description of key information

Based on the available data, FAT 41045 is considered to be not irritating to rabbits' skin and eyes.

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

Single dose, in vivo skin irritation (OECD 404) and eye irritation (OECD 405) studies in the rabbit were performed in compliance with GLP with FAT 41030 a structural analogue of FAT 41045. Both substances are very similar in their chemical structure and, as demonstrated, in a number of physicochemical properties. Therefore, the use of these studies for read-across is considered to be appropriate, thus avoiding duplicate tests. In addition, availability of these two in vivo studies facilitated waiving of the respective in vitro corrosion/irritation studies.

 

In vivo skin irritation:

Topical, semi-occlusive 4 hour application of FAT 41030 to intact rabbit skin did not elicit any oedema throughout the 15 day observation period (overall mean score at 24, 48 and 72 hours after patch removal in 3 animals = 0.0). Erythema or other signs of irritation were not evident whenever evaluation of the treated skin was possible. Marked, red staining of the treated skin by the dark red coloured test material prevented erythema reading in all animals at 1 and 24 hours and in 2 animals at 48 hours after patch removal). The red staining had not fully disappeared by the end of the observation period, but a trend to reversibility was evident in all animals.Corrosive effects on the treated skin were not evident throughout the study.

 

In vivo eye irritation

Instillation of FAT 41030 into the conjunctival sac of rabbit eye produced mild, early-onset and transient ocular changes such as slight watery discharge, swelling and reddening of the conjunctivae and sclerae. These effects were reversible and were no longer evident at 48 hours after treatment. In addition, red staining of the treated eyes seen until the 48-hour reading was attributed to the test material. Cornea or iris were unaffected in all animals. Corrosion was not seen at any observation time point. Overall ocular mean scores at 24, 48 and 72 hours after instillation in 3 animals were 0.00 for corneal lesions, 0.00 for iris lesions, 0.33 for conjunctival redness and 0.00 for chemosis. Thus toxicologically significant or irreversible damage to the rabbit eye were not evident.

 

Respiratory irritation

Data on respiratory irritation are unavailable.

Justification for classification or non-classification

FAT 41045 is not subject to classification according to the CLP (Reg. 1272/2008) or DSD (Dir. 67/548/EEC) regulations regarding skin or eye irritation, as skin reactions indicative of irritation or corrosion or ocular findings necessitating classification were not evident in the two in vivo irritation studies with FAT 41030.

 

The finding of staining of the skin by FAT 41030 is considered to be inherent with the nature of the test material being a dye rather than representing a toxicologically relevant effect. In addition, a trend to reversibility of this finding was evident in all animals. The findings of red remnants in or staining of the treated eye in the eye irritation study had fully disappeared in all animals, at the latest, by 72 hours after instillation and therefore, do not pose a finding requiring classification.