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Diss Factsheets

Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Documentation insufficient for assessment.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1982

Materials and methods

Test guideline
Qualifier:
no guideline available
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
2,4-dichloro-5-sulphamoylbenzoic acid
EC Number:
220-358-3
EC Name:
2,4-dichloro-5-sulphamoylbenzoic acid
Cas Number:
2736-23-4
Molecular formula:
C7H5Cl2NO4S
IUPAC Name:
2,4-dichloro-5-sulphamoylbenzoic acid
Test material form:
solid - liquid: suspension
Details on test material:
M12325 was supplied by Hodogaya ChemicalCo., Ltd. (Tokyo, Japan).
State: water-soluble white powder
Melting point of 232 to 233.5°C.

Test animals

Species:
mouse
Strain:
ICR
Sex:
female
Details on test animals or test system and environmental conditions:
Female weight at study initiation: 16 to 18 g

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
water
Remarks:
Distilled water
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
14 days
Frequency of treatment:
Twice daily doses
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
300 mg/kg bw
Basis:
no data
Remarks:
Doses / Concentrations:
1000 mg/kg bw
Basis:
no data
No. of animals per sex per dose:
10 female/dose

Examinations

Statistics:
The significance of differences in survival rate was evaluated by the Fisher exact test.

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
not examined
Food efficiency:
not examined
Water consumption and compound intake (if drinking water study):
not examined
Ophthalmological findings:
not examined
Haematological findings:
not examined
Clinical biochemistry findings:
not examined
Urinalysis findings:
not examined
Behaviour (functional findings):
no effects observed
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
not examined
Histopathological findings: non-neoplastic:
not examined
Histopathological findings: neoplastic:
not examined
Details on results:
The substance at multiple doses up to 1000 mg/kg was neither lethal nor productive of significant behavioral, neurological, or autonomic nervous system abnormalities throughout the experimental period of 14 days.

Effect levels

Dose descriptor:
NOAEL
Effect level:
> 1 000 mg/kg bw/day (nominal)
Sex:
female
Remarks on result:
not determinable
Remarks:
no NOAEL identified

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The substance at multiple doses up to 1000 mg/kg was well tolerated throughout the experimental period of 14 days in mice.