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Key value for chemical safety assessment

Toxic effect type:
dose-dependent

Effects on fertility

Description of key information

According to a reproductive/developmental toxicity study similar to OECD 414 conducted on an analogue sustance there is no indication that the substance has an effect on fertility. In addition, the available 28-day study (OECD 407) does not indicate adverse effects on reproductive tissues or organs.

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

Effects on developmental toxicity

Description of key information

According to a reproductive/developmental toxicity study similar to OECD 414 conducted on an analogue sustance it is concluded that the substance is not selectively toxic to embryo-fetal development and did not result in teratogenicity, even at a maternally toxic dosage. In addition, the available 28-day study (OECD 407) does not indicate adverse effects on reproductive tissues or organs.

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
160 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Toxicity to reproduction: other studies

Description of key information

There are currently no studies available to assess the reproductive toxicity of 4-tert-butylcyclohexanol.

On the basis of the results of a reproductive/developmental toxicity study similar to OECD 414 conducted on an analogue substance, a maternal NOAEL has been set up to 160 mg/kg bw/d. The only observation associated with treatment with the test material at this dose-level was moderate excess salivation occurring once in each of two rats. This finding is a common response to a strong tasting substance and was therefore not considered as adverse. The 640 mg/kg bw/d dose-level was associated with body weight losses, reduced body weight gains and feed consumption values.

One female in this dose group was sacrificed due to severe adverse clinical observation. It is unclear whether this death, occurring in a single animal, should be considered as an adverse effect of the test substance.

The developmental NOAEL is also 160 mg/kg bw/d. Transient retardations in foetal development associated with 640 mg/kg bw/d dosage included a significant reduction in foetal body weight and associated significant increases in moderate dilation of the renal pelvis and delayed ossification of the caudal vertebrae, fore- and hind-limb phalanges and hind-limb metatarsals.

Based on the results of this study, 4 -tert-butylcyclohexyl is considered to be not selectively toxic to embryo-foetal developmental and did not result in teratogenicity, even at maternally toxic dosage.

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).

Justification for classification or non-classification

Based on the available information, the test material is not classified according to the annex VI of the Regulation (EC) No. 1272/2008 (CLP) and of the Directive 67/548/EEC.