Registration Dossier

Administrative data

Endpoint:
sub-chronic toxicity: other route
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only short abstract available

Data source

Reference
Title:
No information
Author:
Knapp, W.K. et al. (1971): Toxicol. Appl. Pharmacol. 19, 393

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Monochlorobenzene has been administered by oral route once a day (via capsule) to dogs 5 days per week over a 93-day period. Clinical and gross and/or microscopic examinations have been performed.
GLP compliance:
not specified
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
IUCLID4 Test substance: no data

Test animals

Species:
dog

Administration / exposure

Route of administration:
other: oral administration via capsule
Duration of treatment / exposure:
93 d
Frequency of treatment:
1 x/d, 5 d/w
Doses / concentrations
Remarks:
Doses / Concentrations:
27.25, 54.5 or 272.5 mg/kg bw/d
Details on study design:
Post-exposure period: no

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Mortality:
mortality observed, treatment-related
Body weight and weight changes:
effects observed, treatment-related
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
effects observed, treatment-related
Clinical biochemistry findings:
effects observed, treatment-related
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
not specified
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified

Effect levels

Dose descriptor:
NOAEL
Effect level:
54.5 mg/kg bw/day
Sex:
not specified

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

Year: 1971 (unclear if "Year of test guideline" or "Year of study completion".)

RM-Freetext:
Mortality: 4 out of 8 of the high dose after 14 - 21 daily
doses; clinical studies prior to death revealed an increase
in immature leucocytes, low blood sugar, elevated serum
glutamic-pyruvic transaminase and alkaline phosphatase, and
in some dogs, increases in total bilirubin and total
cholesterol. At the high level, there were gross and/or
microscopic pathology in liver, kidney, gastrointestinal
mucosa, and hematopoietic tissue of the dogs which died and,
less extensively, in the dogs which were sacrificed at the
end of the exposure period. No consistent signs of chloro-
benzene effects were evident in the dogs at the intermediate
and low levels.

Applicant's summary and conclusion