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Key value for chemical safety assessment

Effects on fertility

Description of key information
no data
Effect on fertility: via oral route
Dose descriptor:
NOAEL
80 mg/kg bw/day
Additional information

There are no reliable fertility studies available. However, no treatment related changes regarding gross examination on reproductive organs were observed in the capsule study for 95-96 days in dogs. Also in this study the histological examination of the testis, ovaries, prostatate, uterus showed no pathological alteration.

In a not assignable oral acute toxicity study male rats revealed microscopically a reduction in spermatogenesis when given one dose of 10.8, 5.42 or 2.7 g/kg bw by stomach tube and the survivors observed for 7 days when they were killed for pathological examination.

Due to the low number of animals and the insufficient documentation the results seems not relevant for the evaluation of fertility.


Short description of key information:
There was no fertility study with 2-chlorotoluene available. No effects on reproductive organs were observed in a 3 month oral capsule study in dogs. The pathologic evaluation consisted of gross and microscopic examination of reproductive organs, in male dogs, prostate and testis ; in the female dogs, mammary gland, uterus, and ovary. No treatment-related changes were observed for any reproductive organ investigated during macroscopic and microscopic examination of all major organs (NOAEL > 80 mg/kg bw/day (dogs, male + female)

Effects on developmental toxicity

Description of key information
The developmental toxicity was examined in CrL:COBS CD (SD)BR rats  using inhalational exposure.
Effect on developmental toxicity: via inhalation route
Dose descriptor:
NOAEC
1.1 mg/m³
Additional information
Rats inhaled analyzed o-chlorotoluene concnetrations of 0, 1,100, 3,100, or 9,000 mg/m³ for 6 hours/day from days 6 to 19 of pregnancy. Animals in the 3,100 mg/m³ group exhibited slight ataxia during exposure. Animals in the 9,000 mg/m³ group displayed ataxia, lacrimation and/or salivation as well as a brownish discoloration of the fur. Beginning at 3,100 mg/m³, a dose-dependent reduction in feed intake and body weight gain was observed, as well as a dose-dependent increase in drinking water consumption. No treatment-related effects were seen for animals in the 1,100 mg/m³ group. The off-spring of the 1,100 and 3,100 mg/m³ groups did not exhibit treatment-related effects. In the 9,000 mg/m³ group, a reduction in fetal and litter weights was observed. The incidence of fetal malformations was increased by 6 fetuses(distributed among 4 litters), which each exhibited brachdactylia on one of its fore or hind paws. 5 of these 6 fetuses simultaneously displayed terminal hemorrhaging in the affected paw. Incorrelation to the reduced mean fetal weight, delayed ossification led to an increased occurence of skeletal variations. The incidence of visceral anomalies was unchanged, however. 
    
A NOAEC of 1.1 mg/l for maternal toxicity and 3.1 mg/l for foetal toxicity was found.

Toxicity to reproduction: other studies

Additional information

no data

Justification for classification or non-classification

From the histopathological examinations of the reproductive organs no adverse effects on fertility are expected. Developmental toxic effects in rats and rabbits occur mostly in the presence of maternal toxicity and without a clear dose-relationship, however as a specific

malformation, brachydactyly. Therefore a classification as Xn, R 63 (Possible risk of harm to the unborn child); GHS: Repr. 2, H361) has to be considered.