Registration Dossier
Registration Dossier
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EC number: 200-539-3 | CAS number: 62-53-3
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Additional information
Aniline caused only slight topical reaction to the skin of rabbits in test for skin corrosion and irritation. An erythema grade 1 was observed in 6/6 rabbits after dermal application of 0.5 ml undiluted aniline. In contrast, during an acute dermal toxicity study dermal exposure to undiluted aniline for supposedly 24 h caused subdermal hemorrhages and severe erythema (Bio-Fax Industrial Bio-Test Laboratories, 1969). Application of undiluted aniline to the skin of 2 rabbits revealed slight erythema, which fully reversed within 8 days after exposure (BASF, 1972). Information from appropriate tests on skin irritation effects in humans is not available. In a study on dermal absoprtion Baranowska-Dutkiewicz (1982) exposed volunteers dermally to 0.25 ml undiluted aniline for 30 min at a relatively low concentration of approximately 0.01 ml/cm2. No dermal reaction in exposed volunteers has been reported.
For the assessment of serious eye damage and eye irritation two animal studies are available. Mean scores of ca. 53/110 for effects on cornea, iris and conjunctivae (moderate to severe effects) were reported within the first 3 days after instillation in one study (Bio-Fax Industrial Bio-Test Laboratories, 1969), whereas in the second study severe conjunctival erythema and edema were observed which did not reverse within a 8 day observation period. Furthermore, pannus formation was observed at the end of the expiration period (BASF, 1972).
Additional information on the eye irritation potential is available from acute inhalation studies in rats exposed head-only to aniline vapor (3mg/l/4h), where mild to severe corneal damage up to corneal clouding was observed until day 14 after exposure had ceased (DuPont de Nemours, 1982).
Justification for classification or non-classification
Appropriate testing of the potential effects of undiluted aniline on the skin showed no signs of corrosivity but only a slight edema. In rabbit eyes, severe effects on the cornea and severe conjunctival irritation were detected; eight days after instillation of the substance pannus formation was detected. According to the criteria in Annex VI to 67/548/EEC aniline is classified as "Xi, Irritant". According to the criteria in Annex I of the CLP regulation (EC) 1272/2008 aniline is classified as Category 1 for the hazard category irreversible effects on the eye/serious damage to eyes. Both classification for serious eye damage and non-classification for skin corrosion and irritation are in accordance with the entries in Annex VI to the CLP regulation.
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