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Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
toxicity to reproduction
Remarks:
other: reproductive organs in a 3 month study were examined
Type of information:
other: reproductive organs in a 3 month study were examined
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: well documented and scientifically acceptable
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974

Materials and methods

Principles of method if other than guideline:
4 dogs/group were given daily oral doses of 5, 20, or 80 mg/kg of o-chlorotoluene (OCT). The control group was given 5% aqueous acacia solution, 0.5 ml/kg. Daily doses were administered for 3 month by capsule.
At the end all animals were killed and necropsied; gross and microscopic examination of all major organs, including reproductive organs; in male dogs prostatate, testis; in female dogs mammary gland, uterus, and ovary.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
purity: 96.4%

Test animals

Species:
other: dog
Strain:
other: Beagle
Sex:
male/female

Administration / exposure

Route of administration:
oral: capsule
Vehicle:
other: 5 % aqueous accacia solution
Details on mating procedure:
not applicable - reproduction organs were examined
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
3 month
Frequency of treatment:
daily
Details on study schedule:
not applicable - reproduction organs were examined
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 5, 20, or 80 mg/kg
Basis:
nominal conc.
No. of animals per sex per dose:
2 males and 2 females/dose
Control animals:
yes, concurrent vehicle

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Dose descriptor:
NOAEL
Effect level:
> 80 mg/kg bw/day
Sex:
male/female
Basis for effect level:
other: 80 mg kg bw/d had no changes towards hematological, pathological-anatomic, or histological parameters

Overall reproductive toxicity

Reproductive effects observed:
not specified

Any other information on results incl. tables

80 mg/kg bw/d administered daily for 3 month had no adverse effects on the reproductive organs on male and female rats

Applicant's summary and conclusion

Executive summary:

4 dogs/group were given daily oral doses of 5, 20, or 80 mg/kg of o-chlorotoluene (OCT). The control group was given 5% aqueous acacia solution, 0.5 ml/kg. Daily doses were administered for 3 month by capsule.

At the end all animals were killed and necropsied; gross and microscopic examination of all major organs, including reproductive organs; in male dogs prostatate, testis; in female dogs mammary gland, uterus, and ovary.

NOAEL = 80 mg/kg bw/d (male and female dogs); the pathological examination revealed no difference between the dosed and control groups