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Toxicological information

Carcinogenicity

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Description of key information

As no studies were available for TEPA, TETA was used for read across. TETA was not locally or systemically carcinogenic when applied to the skin of mice up to a level of 5%.

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:
no adverse effect observed

Additional information

TETA was not locally or systemically carcinogenic when applied to the skin of mice up to a level of 5%.

No local effects were seen in a 2-year dermal study (application 3 times/week) in mice using a 5% solution in water (1.25 mg/mouse), estimated to be applied at 25 ul/0.25 cm2 which corresponds to 1.25 mg/0.25 cm2, or 5 mg/cm2.

No local effects were seen in another 2-year dermal study in mice (application 3 times/week) using a 2% solution in ethanol (0.5 mg/mouse), estimated to be applied at 25 ul/0.25 cm2 which corresponds to 0.5 mg/0.25 cm2, or 2 mg/cm2.


Justification for selection of carcinogenicity via oral route endpoint:
TEPA is not classified as mutagen and there is no evidence from repeated dose studies that TEPA (also based on data from TETA) is able to induce hyperplasia and/or pre-neoplastic lesions.

Justification for selection of carcinogenicity via inhalation route endpoint:
TEPA is not classified as mutagen and there is no evidence from repeated dose studies that TEPA (also based on data from TETA) is able to induce hyperplasia and/or pre-neoplastic lesions.

Justification for selection of carcinogenicity via dermal route endpoint:
No study was selected because more than study was used to get to this conclusion.

Justification for classification or non-classification

Based on read across with TETA, TEPA was not considered a carcinogenic compound, and as such no classification is needed.