4-chlorotoluene

Toxicity to reproduction: other studies

Administrative data

Endpoint:

toxicity to reproduction: other studies

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: guideline study

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Principles of method if other than guideline:

5 male and female Wistar rats each received for 29 days a dose of 0, 50, 200, or 800 mg/kg bw p-chlorotoluene per gavage. Mortality, clinical signs, body weight, clinical chemistry, hematology and urinalysis were performed including gross pathology and histopathology after the termination of the study.
In this Amendment results of additional histopathlogieal investigations on reproduction organs taken from Wistar rats of a 4-week oral gavage rat study (see Bayer Report No.: 21980 January 21, 1993) are reported.

GLP compliance:

yes

Type of method:

in vivo

Test material

Test material information

Constituent 1

Reference substance name:

4-chlorotoluene

EC Number:

203-397-0

EC Name:

4-chlorotoluene

Cas Number:

106-43-4

Molecular formula:

C7H7Cl

IUPAC Name:

4-chlorotoluene

Details on test material:

p-chlorotoluene - purity: 99.8 %

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Analytical verification of doses or concentrations:

yes

Duration of treatment / exposure:

29 days

Frequency of treatment:

daily: 7d/w

Duration of test:

29 days

Doses / concentrations

Remarks:

Doses / Concentrations:
0, 50, 200 or 800 mg/kg bw/d dissolved in Polyethylenglycol 400
Basis:
nominal conc.

No. of animals per sex per dose:

5 per sex per dose

Control animals:

yes, concurrent vehicle

Details on study design:

Duration of test: 29 d

Results and discussion

Effect levels

Dose descriptor:

NOAEL

Effect level:

800 mg/kg bw/day

Sex:

male/female

Observed effects

see remarks on results including tables and figures

Any other information on results incl. tables

NOAEL (general toxicity): 200 mg/kg bw/d

The histopathological investigations revealed no changes in testes,  
epididymides, prostrate, seminal vesicles, ovaries/oviduct, uterus 
and  vagina which can be attributed to the treatment. Thus, from the 
viewpoint  of pathology and based on the organs investigated and 
reported in this  amendment the NOAEL is 800 mg/kg bw/d for both 
sexes.

Applicant's summary and conclusion

Executive summary:

5 male and female Wistar rats each received for 29 days a dose of 0, 50, 200, or 800 mg/kg bw p-chlorotoluene per gavage. Mortality, clinical signs, body weight, clinical chemistry, hematology and urinalysis were performed including gross pathology and histopathology after the termination of the study.

In this Amendment results of additional histopathlogieal investigations on reproduction organs taken from Wistar rats ofa 4-week oral gavage rat study (see Bayer Report No.: 21980 January 21, 1993) are reported.

The histopathological investigations revealed no changes in testes,epididymides, prostrate, seminal vesicles, ovaries/oviduct, uterusand  vagina which can be attributed to the treatment. Thus, from theviewpoint  of pathology and based on the organs investigated andreported in this  amendment the NOAEL is 800 mg/kg bw/d for bothsexes.