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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Effects on fertility

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
Additional information

No animal studies were conducted with the test substance to investigate possible substance-related effects on the reproductive performance. In a subchronic oral feeding study conducted in male and female CD rats after exposure to 700, 2000, 6000 ppm (corresponding to 40, 122, 376 mg/kg bw/day in males and 48, 136, 420 mg/kg bw/day in females) no findings of pathological significance were noted in testes and epididymis of males as well as in uterus and ovaries of females in comparison with untreated control animals (Huntingdon, 1979). Similarly, in a subchronic oral feeding study conducted in Beagle dogs after exposure to 200, 600, 2000 ppm (corresponding to 8.5, 24.7, 84.1 mg/kg bw/day for males and 9.2, 28.3, 90.2 mg/kg bw/day for female) no findings of pathological significance were noted in testes and epididymis of males as well as in uterus and ovaries of females in comparison with untreated control animals (Life Science Research, 1980).


Short description of key information:
In two subchronic oral feeding study conducted in rats and dogs, no effects on reproductive organs have been observed.

Effects on developmental toxicity

Description of key information
In a prenatal developmental toxicity study (Ciba-Geigy, 1983, OECD 414) 25 pregnant Tif:RAIf (SPF) rats per dose were treated daily by gavage with 400, 1200 and 2400 mg test substance per kg bodyweight from day 6 to 15 of gestation. No adverse effects have been observed. Based on the findings a NOEL of 2400 mg/kg bw (highest dose tested) was deduced for developmental toxicity.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
2 400 mg/kg bw/day
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
Additional information

In a prenatal developmental toxicity study following OECD guideline 414, 25 pregnant Sprague-Dawley derived Tif:RAIf (SPF) rats per dose group were treated daily with the test article by gavage at 400, 1200, 2400 mg/kg body weight from day 6 to 15 of gestation. Dams were killed on day 21 and fetuses removed by Caesarian section. Body-weight gain was comparable for the dams of all groups. Food consumption of the experimental groups, however, showed some reduction during the treatment period (from day 6 of pregnancy) in comparison with the vehicle control. One female of the low dose group died due to an intubation error.

The rates of implantation sites per female were comparable for all groups. No differences between control and test groups were reported regarding fetal death (resorption), male to female ratio of fetuses and average fetal body weight. A slight but significant increase was noted for the live fetuses of the intermediate and, at a lower extent, of the high-dose group. This finding, however, is not assumed to be of a biological relevance.

Some instances of anomalies and/or malformations were recorded for the dose groups as well as for the vehicle control: two fetuses from one litter of the low dose displayed subpleural haemorrhage; mandibular aplasia and partial aplasia of the lungs, respectively, were found in one fetus each of the intermediate dose, omphalocele occurred in one fetus of the high dose and anasarca in one fetus of the vehicle control group. These findings are considered to be of a spontaneous origin and not related to the treatment. The incidences of mandibular aplasia, omphalocele and anasarca were found to be 0.05%, 0.04% and 0.12%, respectively, in the historical control population of the breed of rats used for the present experiment. Likewise, the occurrence of sternebral anomalies in all groups was not assumed to be of an experimental significance, the overall incidence of sternebral anomalies being 0.37% in the historical control. Concerning the status of skeletal maturation of the fetuses, no delay of ossification could be found for the experimental groups in comparison with the vehicle control. Based on the findings a NOAEL of 2400 mg/kg body weight (highest dose tested) was derived for maternal and developmental toxicity.


Justification for selection of Effect on developmental toxicity: via oral route:
Guideline study

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

-No classification required for toxicity to reproduction.

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008:

-No classification required for toxicity to reproduction.

Additional information