Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

There is currently no data available to assess the reproductive toxicity of 4-tert-butylcyclohexanol.

According to Regulation (EC) No 1907/2006 Annex VIII, Section 8.7.1, Column 2 no screening study for reproductive/developmental toxicity needs to be conducted since an OECD 414 study is proposed. In addition, the available 28-day study does not indicate adverse effects on reproductive tissues or organs.

In a GLP Guideline study according to OECD guideline 407 rats were administered 4-tert-butylcyclohexanol via gavage at concentrations of 50, 100 and 300 mg/kg bw/day for 28 days. Gross pathology and histopathology included the determination of testes and epididymides weight as well as examination of testes, epididymides, seminal vesicles, ovaries, vagina and uterus. No changes in absolute or relative testes weight were noted. The relative epididymides weight was significantly increased at the end of the recovery period. However the absolute epididymides weight was not statistically significant increased and there were no accompanied microscopic findings. No gross and histopathological findings were observed in any of the examined reproductive tissues and organs. Therefore, 4-tert-butylcyclohexanol is considered not to have adverse effect on reproductive tissues or organs at concentrations, where systemic toxic effects were present (e. g. clinical signs, effects on neurobehaviour, motoractivity and body weight) and thus a two-generation study does not need to be proposed.


Short description of key information:
No data available.

Justification for selection of Effect on fertility via oral route:
According to Regulation (EC) No 1907/2006 Annex VIII, Section 8.7.1, Column 2 no screening study for reproductive/developmental toxicity needs to be conducted since an OECD 414 study is proposed. In addition, the available 28-day study (OECD 407) does not indicate adverse effects on reproductive tissues or organs.

Effects on developmental toxicity

Description of key information
No data available.
OECD 414 Guideline study is proposed.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available (further information necessary)
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

There is currently no data available to assess the reproductive toxicity of 4-tert-butylcyclohexanol. However, a study according to OECD Guideline 414 is proposed to assess the potential of the test material to cause developmental toxicity/teratogenicity.

Justification for classification or non-classification

No information on toxicity to reproduction is available.