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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.