Registration Dossier
Registration Dossier
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EC number: 407-240-9 | CAS number: 159604-94-1 BLUE 10 25 964
Endpoint summary
Administrative data
Description of key information
Not skin irritant
Eye Irrit. 2, H319
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:
- adverse effect observed (irritating)
Additional information
Skin irritation/corrosion:
The purpose of this study was to assess the possible irritation or corrosion potential of the test item when a single dose was placed on the skin of rabbits.
This study was carried out in accordance with OECD Guideline No. 404, "Acute Dermal Irritation / Corrosion' and EEC Directive 84/449/EEC, Part B. 4, "Acute Toxicity - Skin Irritation".
The test item was applied on the shaved skin using semi-occlusive dressings for 4 hours, followed by four observations at approximately 1, 24, 48 and 72 hours after removal of the dressings and the remaining test substance.
Under the conditions of this study, the test item resulted in very slight erythema in all three animals. The erythema was reversible within 24 hours after exposure in all three animals.
In the area of application, blue staining of the treated skin by the test substance was observed.
No corrosive effect occurred on the skin in any of the rabbits.
No signs of systemic intoxication were observed during the study period.
The test item resulted in a primary irritation index of 0 (non irritating) when applied to the intact rabbit skin.
Eye irritation/corrosion:
The purpose of this study was to assess the possible irritation or corrosion potential when a single dose of the test item was placed in the conjunctiva) sac of a rabbit eye.
This study was carried out in accordance with OECD Guideline No. 405, "Acute Eye Irritation / Corrosion" and EEC Directive 84/449/EEC, Part Be 5, "Acute Toxicity - Eye Irritation' ,
The test item was instilled in one of the eyes of each of the three animals, followed by six observations at approximately 1, 24, 48 and 72 hours and 7 and 14 after test article administration.
Under the conditions of this study, the test item resulted in adverse effects of the cornea and iris in one animal and in adverse effects of the conjunctivae in all three animals.
The opacity of the cornea was reversible within 7 days and the injection of the iris was reversible within 48 hours in the one animal .
The irritation of the conjunctivae was reversible within 14 days in all three animals.
No ocular corrosion was observed in any of the animals.
No signs of systemic intoxication were observed during the study period.
Justification for classification or non-classification
Based on the information available for skin and eye irritation and according to the CLP Regulation n.1272/2008, table 3.2.2 "Skin irritation category", the substance is not classified as skin irritant.
A classification as eye irritant applies, according to table 3.3.1 "Serious eye damage", as two animals out of three showed a positive response to conjuctivae redness (score ≥ 2).
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