Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
toxicity to reproduction: other studies
Remarks:
reproductive organs in a 3 month study were examined
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: well documented and scientifically acceptable
Cross-reference
Reason / purpose for cross-reference:
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:
no

Test material

1
Chemical structure
Reference substance name:
2-chlorotoluene
EC Number:
202-424-3
EC Name:
2-chlorotoluene
Cas Number:
95-49-8
Molecular formula:
C7H7Cl
IUPAC Name:
1-chloro-2-methylbenzene

Test animals

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

Administration / exposure

Route of administration:
oral: capsule
Vehicle:
other: 5 % aqueous accacia solution
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
3 months (103 - 104 days)
Frequency of treatment:
daily
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 5, 20 or 80 mg/kg bw/d in a 5 % aqueous accacia solution
Basis:
actual ingested
No. of animals per sex per dose:
2 males and 2 females/dose
Control animals:
yes, concurrent vehicle
Details on study design:
Gross and histopathological examination of male and female reproduction organs.

Results and discussion

Effect levels

Dose descriptor:
NOAEL
Effect level:
> 80 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Remarks on result:
other: see 'Remarks'
Remarks:
Gross and microscopic examination of all major organs, including reproductive organs; in male dogs prostate, testis; in female dogs mammary gland, uterus, and ovary revealed no adverse findings.

Observed effects

Gross and microscopic examination of all major organs, including reproductive organs; in male dogs prostate, testis; in female dogs mammary gland, uterus, and ovary revealed no adverse findings.

Any other information on results incl. tables

Gross and microscopic examination of all major organs, including reproductive organs; in male dogs prostate, testis; in female dogs mammary gland, uterus, and ovary revealed no adverse findings. 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.