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Administrative data

Description of key information

Distillate aromatic extract was found to have carcinogenic potential when applied repeatedly to the clipped skin of mice.

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
Study duration:

Justification for classification or non-classification

Based on the incidence of cancer after dermal exposure, distillate aromatic extracts are classified as Carcinogenic, Category 1B (H350) according to the EU CLP Regulation (EC No. 1272/2008).

Additional information

Four well conducted skin painting studies in mice were identified. In the key study, 50 uL aliquots of material were applied twice / week for 2 years to the clipped skin of mice. Following treatment there was an increased incidence of skin tumours compared to controls, Thirty one of 42 mice showed tumours, with an average latency period of 52 weeks.

In further study (Gradiski, 1983) mice were treated with 0.05 millilitres of undiluted test material three times weekly for the first month and twice weekly for the next 11 months to the shorn dorsal lumbar skin of a group of 30 mice. A group of 60 female mice shaved once weekly served as untreated controls.

At study termination, depilation and cutaneous atrophy was noted and attributed to skin irritation or repeated scratching. Eight-three percent of animals treated with distillate aromatic extract developed one or more skin tumours; 33% benign, 17% malignant and 33% benign and malignant. Observed malignant tumours included squamous cell carcinomas and sarcomas. By comparison, no skin tumours or cutaneous lesions were observed in any of the white oil or untreated control animals.

The authors concluded that dermal exposure to the tested distillate aromatic extract, in addition to causing skin irritation, resulted in skin cancer in the mouse. It was observed that general mortality decreases as the refinement of the oil increases.  Distillate aromatic extract, which contains polycyclic aromatic hydrocarbon substances, produced a significant biological response and was found to be carcinogenic.

Justification for selection of carcinogenicity via dermal route endpoint:

Well conducted 2 yr skin painting study. One of 4 studies showing similar results

Carcinogenicity: via dermal route (target organ): other: skin