Registration Dossier
Registration Dossier
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EC number: 413-550-5 | CAS number: 142068-96-0 H112339
Endpoint summary
Administrative data
Description of key information
Summary of irritation data
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin irritation / Corrosion.
A single study was evaluated on this endpoint. Three female rabbits each received a single four hour application of the test sample to the shorn flank. The animals were assessed for any signs of irritation for up to 3 days after application. The test sample stained the application sites of all animals and prevented assessment of erythema. On day 3 of the study, animals were humanely killed and samples of skin were taken and examined histopathologically for signs of skin irritation. Two of the three test sections showed slight multifocal or diffuse acanthosis, slight or moderate multifocal or diffuse inflammatory cell infiltration and slight multifocal parakeratosis/surface debris. Minimal focal epithelial necrosis was also present in one test site. The skin section from the remaining test site showed minimal multifocal inflammatory cell infiltration. Control sections from all animals showed minimal multifocal inflammatory-cell infiltration.
The histopathological findings indicate an irritant effect of slight to moderate intensity in two animals, There was no evidence, of widespread necrosis, therefore it is likely that the effects were reversible.
Substance HI 12339 was a moderate irritant to rabbit skin following a single four hour application.
Eye irritation.
A single study was evaluated on this endpoint.Application of the test sample into the conjunctival sac of three rabbits caused slight initial pain. The test sample stained the tissues of the eye red and prevented a complete assessment of ocular irritation. Corneal and iridial effects were completely obscured in one animal throughout the study and in the remaining two animals up to day 3 of the study. From day 4 after application there were no corneal or iridial effects in these two animals.
Due to the red staining, it was not possible to assess conjunctival redness in any animal during the study. However, slight to mild chemosis and slight to severe discharge were observed in all animals up to day 3 of the study. Additional signs of ocular irritation included dried secretions of the periorbital skin in 1 animal and slight to moderate Harderian discharge in 2 of the rabbits. Following instillation of fluorescein stain, up to one quarter of the cornea of one rabbit became stained, indicating possible corneal damage. This animal showed no reaction to fluorescein stain from day four of the study. None of these additional signs of ocular irritation were evident in any animal from day 4 after application of the test sample.
On the basis of the available scores, Substance H112339 was at least a mild irritant (class 4 on a 1-8 scale) to the rabbit eye. The test sample is unlikely to be a severe ocular irritant since no signs of irritation were evident from day 4 after dosing.
As a dye substance, the test material is not considered to cause discoloration of the cornea at the 21-day observation point as specified in the regulation, and hence is not considered to fulfil the criteria for classification as a Category 1 eye irritant. No classification is therefore required.
Respiratory irritation
Respiratory irritation was not assessed; however no effects on the animals were noted in any associated studies.
The following information is taken into account for any hazard / risk assessment:
Skin and eye irritation are discussed.
Value used for CSA:
- Skin irritation / corrosion: Irritating (Skin Irrit. 2 - H315)
- Eye irritation: Moderately irritating (classification not applicable)
Effects on skin irritation/corrosion: moderately irritating
Effects on eye irritation: moderately irritating
Justification for classification or non-classification
The above studies have all been ranked reliability 1 according to the Klimish et al system. This ranking was deemed appropriate because the studies were conducted to GLP an in compliance with agreed protocols. Sufficient dose ranges and numbers are detailed; hence it is appropriate for use based on reliability and animal welfare grounds.
The above results triggered classification under the Dangerous Substance Directive (67/548/EEC) and the CLP Regulation (EC No 1272/2008) as follow:
Dangerous Substance Directive (67/548/EEC): Xi – R38
CLP Regulation (EC No 1272/2008): Skin Irrit. 2 - H315
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