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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
short-term repeated dose toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reason / purpose for cross-reference:
read-across source
Key result
Dose descriptor:
NOAEL
Effect level:
> 2 680 mg/kg diet
Based on:
other: calculated for target substance to be registered
Sex:
male/female
Basis for effect level:
other: NOAEL = highest dose tested
Key result
Dose descriptor:
NOAEL
Effect level:
> 160 mg/kg bw/day (actual dose received)
Based on:
other: calculated for target substance to be registered
Sex:
male/female
Basis for effect level:
other: NOAEL = highest dose tested
Key result
Critical effects observed:
no

Calculation of the NOAEL for the read-across target substance, i.e. the phosphate salt of cyclohexyldimethylamine, from the result obtained in the OECD 422 study performed with the read-across source substance cyclohexyldimethylamine.

In the OECD 422 study the NOAEL was derived at the level of 1500 ppm cyclohexyldimethylamine in the diet; this was the highest dose tested due to palatability issues. This dietary concentration corresponded to dose levels of 91 – 104 mg/kg body weight/day for males and to 85 – 147 mg/kg body weight/day for females. This is summarised to a NOAEL of cyclohexyldimethylamine of > 90 mg/kg body weight/day for males and females.

This NOAEL is converted to the NOAEL of the read-across target substance, i.e. the phosphate salt of cyclohexyldimethylamine, by multiplication with the factor 1.786 resulting in 2680 ppm in diet and 160 mg/kg body weight/day.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

In the repeated dose oral toxicity study performed with the read-across source substance no effects were observed up to and including the highest dose of 1500 ppm in the diet. This dose level of the r-a source substance corresponds to a dose level of the target substance to be registered of > 160 mg/kg body weight/day for males and females. In the absence of any adverse effects non-classification is justified.