Registration Dossier

Administrative data

Description of key information

One key read-across skin irritation study was identified for C-6 normal and iso paraffins (hexanes) and naphthenes (methyl-cyclohexane, dimethylcyclohexane), 25-35% n-hexane   (Hine, 1970; Klimisch score =2) and one key read-across eye irritation study for C-6 normal and iso paraffins (hexanes) and naphthenes (methyl-cyclohexane, dimethylcyclohexane), 25-35% n-hexane  (Hine, 1970; Klimisch score =2).

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)

Additional information

In a key read-across skin irritation study of C-6 normal and iso paraffins (hexanes) and naphthenes (methyl-cyclohexane, dimethylcyclohexane), 25-35% n-hexane  (Hine, 1970; Klimisch score=2), test material was applied to both intact and abraded skin of 6 male rabbits. The test area was covered with gauze for 24 hrs. After the exposure period, the animals were scored for irritation at 24 and 72 hrs after start of exposure. The primary dermal irritation index (PDII) was 1.92 which is calculated from the average erythema score and the average oedema score. 

In a key read-across eye irritation study of C-6 normal and iso paraffins (hexanes) and naphthenes (methyl-cyclohexane, dimethylcyclohexane), 25-35% n-hexane (Hine, 1970; Klimisch score=2), the potential of hexane to cause irritation to eyes was examined. Approximately 0.1 ml of test substance was placed in the eyes of six male rabbits. The rabbits were examined for signs of irritation at 24, 48, and 72 hrs after start of exposure. Only 1 animal showed signs of irritation (score of 1) at 24 hrs. The mean conjunctivae, chemosis, iris, and cornea scores were 0.33, 0.0, 0.0, and 0.0 respectively. 

Justification for classification or non-classification

 n-Hexane is classified in EU EU67/548/EEC Annex 1as a Category 2 skin irritant.