Registration Dossier

Administrative data

Description of key information

AHTN does not show neurotoxicity as shown by neuropathological examination of brain, spinal cord, and peripheral nerves.

The EU Risk Assessment Report discussed the neurotoxic potency of AHTN. The report referenced to two subchronic dermal studies that were primarily designed to screen for possible neurotoxicity, because another closely related synthetic musk, Acetyl Ethyl Tetramethyl Tetralin (AETT), appeared to be neurotoxic. Therefore, special neuropathological examination of brain, spinal cord, and peripheral nerves was included for 2 animals per dose group and AETT was included as a positive control.

According to theEU Risk Assessment Report, in these studies, AHTN (Tonalid) was administered to 5 female rats (CRL: COBS CD) in ethanol via the intraperitoneal route at a dose of 36 mg/kg bw/day for a period of 4 days. The purpose of this study was to determine if AHTN caused blue coloration similar to acetyl ethyl tetramethyl tetralin (AETT) a polycyclic musk identified as a neurotoxic ingredient and which induced blue coloration to the internal organs of dosed animals. AHTN did not induce blue coloration of the internal organs in the treated animals. Clear evidence of neurotoxicity, both clinically and pathologically, was seen with the positive control but no such evidence for AHTN was seen in either study at any dose level.

Source:EU Risk Assessment AHTN, European Chemicals Bureau, May 2008

Key value for chemical safety assessment

Effect on neurotoxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no study available

Effect on neurotoxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Effect on neurotoxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Based on the available information classification for neurotoxicity is not warranted in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.