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EC number: 219-941-5
CAS number: 2579-20-6
In the examination of offspring, no changes attributed to the test
substance were noted in the number of offspring, live birth index, sex
ratio, viability index on Day 4, external features, clinical signs, body
weights, or necropsy findings.
A combined repeated dose toxicity and reproductive toxicity screening
study was conducted on the test substance
1,3-Bis(aminomethyl)cyclohexane (1,3-BAC). The study
was performed according to OECD test guideline 422, and in compliance
Male and female rats were dosed at levels 0 (vehicle control), 10, 60,
and 300 mg/kg bw/day of 1,3-BAC as a solution in water; males were dosed
for 42 days in total including the mating period, females were dosed
from 14 days before mating until day 4 of lactation. The
clinical and pathological effects on reproduction in both the parental
generation and the offspring were recorded.
The test substance had no effects on the reproductive parameters of the
parental animals, nor on the developmental parameters of the offspring. The
no observed effect level of 1,3-Bis(aminomethyl)cyclohexane for
reproductive / developmental toxicity was considered to be 300 mg/kg/day
in parental animals and offspring.
Short description of key information:
NOEL, rat, reproductive / developmental toxicity screen = 300 mg/kg
bw/day (Parental animals and offspring).
NOAEL, rat, oral developmental toxicity (OECD Guideline 414 (Prenatal
Developmental Toxicity Study)) = 100 mg/kg bw/day (maternal and fetal
Formulation analysis: the stability was confirmed for 1,3-BAC in water
formulations and the mean concentrations of 1,3-BAC in test formulations
analysed for the study were within ±8% of nominal concentrations,
confirming accurate formulation.
The influence of 1.3-BAC on pregnancy, embryo-fetal survival and
development, was assessed when administered to female Sprague-Dawley
rats at doses up to 300 mg/kg/day during the organogenesis phase of
pregnancy (Days 6 to 19 after mating, inclusive) in a Prenatal
Developmental Toxicity Study (OECD 414) and from 14 days before mating
until day 4 of lactation in a combined repeated dose toxicity and
reproductive toxicity screening study.
In the prenatal developmental toxicity study, treatment with 1,3 -BAC at
30,100 and 300 mg/kg/day showed no effects of treatment on embryo-fetal
growth, survival or development however the dose of 300 mg/kg/day was
not well tolerated by pregnant females.
In the reproductive/developmental toxicity screening study, the test
substance had no effects on estrus cycle, copulation index, fertility
index, gestation index, gestation length, numbers of corpora lutea or
implantations, implantation index, delivery index, parturition, or
maternal behaviour at doses of 10, 60, 300 mg/kg/day. As in the prenatal
developmental toxicity study, treatment at 300mg/kg/day had effects on
the general conditions of some of the animals and macroscopic changes
considered attributed to the test substance were noted in the stomach of
both sexes and in the testes and epididymis of males at 300 mg/kg/day.
Data from both studies concurs with the conclusion that the maternal and
fetal no observed adverse effect level (NOAEL) for developmental
toxicity is 100 mg/kg/day.
No effects on reproductive or developmental parameters were observed at
doses up to 100 mg/kg/day. As there was no evidence for reproductive
toxicity in the screening study conducted or developmental toxicity in
prenatal developmental toxicity study, classification for
reproductive toxicity does not apply according to the CLP Regulation (EC
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