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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: well documented and scientifically acceptable

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1974
Reference Type:
secondary source
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. A general observation, body weight changes, hematology, clinical biochemistry, and urinalysis were performed. Organ weights, bone marrrow and hepatic microsomal activity was examined and pathological findings were evaluated.
GLP compliance:
no

Test material

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

Test animals

Species:
dog
Strain:
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
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

Results and discussion

Effect levels

Dose descriptor:
NOEL
Effect level:
20 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

all dose groups: no effects on behaviour, survival, eyes,
haematology, clinical chemistry, bone marrow;
no findings in the histopathological examinations
attributable to treatment
80 mg/kg bw/d: 1/4 females vomited 3 times between test day
10 and 17 and during the 3rd treatment week, red blood was
observed in this animal feces (no further information)

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. A general observation, body weight changes, hematology, clinical biochemistry, and urinalysis were performed. Organ weights, bone marrrow and hepatic microsomal activity was examined and pathological findings were evaluated.

NOEL = 20 mg/kg bw/d; dogs which received daily oral doses of 5, 20, or 80 mg o-chlorotoluene were similar in all respects to the controls. The save level was 20 mg/kg.