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Diss Factsheets

Toxicological information

Endpoint summary

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Administrative data

Key value for chemical safety assessment

Toxic effect type:
dose-dependent

Effects on fertility

Description of key information

There were 10 male and 10 female rats in the control group, and 10 male and 10 female rats in the treated group. All animals divided into groups by random. One male to one female mating way was used in this study. The Oestrous cycles of females were monitored in PE, PM until mated successfully, and on the day of euthanasia. The clinical observation were performed once a day in
all periods. Males were weighed on the day of shaving and the dosing day, by weekly and at the D28. And females were weighed on the day of shaving, and PM0, PM7, M0, G0, G7, G14,G20 and PND0, PND4, PND11and PND 13. Food consumption of female rats were measured once a week during pre-mating, gestation and lactation. Food consumption of male rats were measured once a week during pre-mating. On PND0/PND4/PND13, each litter was weighed and the pups of each litter were counted and sexed. On PND4, the litter size was adjusted, the AGD was measured and the blood for measuring T4 of pups was sampling. On PND13, blood for measuring T4 of pups was
sampling, nipple and areolas of each litter were counted and all pups were executed. For all adult male rats, execution was performed on D2 8 , the blood for measuring T4 was sampling and sperm ( sperm motility, sperm count and sperm malformation rate) were observed. For all adult female rats, execution was performed on PND13, the blood for measuring T4 was sampling.
At the end of the exposure, all male and female rats and pups were gross necropsy. For adult female rats, ovaries ( in pairs) , uterus and cervix and thyroid were weighed and reserved. For adult male rats, testes epididymides, prostate, seminal vesicles plus coagulating glands as a whole, thyroid, levator ani plus bulbocavemosus muscle complex Cowper’ s glands, and glands penis were weighed, and testes epididymides, prostate, seminal vesicles plus coagulating glands as a whole and thyroid were reserved. For pups, thyroid (pups of one male and one female from each litter) were weighed and reserved. The testicles (for male), epididymis (for male), ovary (for female)
were histopathological examined.


Based on this study, there was not any clear evidence of toxicity of Diethylhexyl Butamido Triazone
at a dose level of 1000mg/kg body weight on male and female reproductive performance such as gonadal function, mating behaviour, conception, development of the conceptus and parturition .

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 adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the results of REPRODUCTION/DEVELOPMENT TOXICITY SCREENING TEST, the substance was not classified as toxicity to reproduction.

Additional information