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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
other: read across from similar substance
Adequacy of study:
key study
Study period:
1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 14 days oral exposure
Deviations:
not specified
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 2-anilino-5-(2,4-dinitroanilino)benzenesulphonate
EC Number:
228-921-5
EC Name:
Sodium 2-anilino-5-(2,4-dinitroanilino)benzenesulphonate
Cas Number:
6373-74-6
Molecular formula:
C18H14N4O7S.Na
IUPAC Name:
sodium 2-anilino-5-(2,4-dinitroanilino)benzenesulphonate

Test animals

Species:
mouse
Strain:
B6C3F1
Sex:
male/female
Details on test animals or test system and environmental conditions:
No data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: water
Duration of treatment / exposure:
14 days
Frequency of treatment:
daily
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:62 mg/kg bwBasis:nominal in diet
Remarks:
Doses / Concentrations:125 mg/kg bwBasis:nominal in diet
Remarks:
Doses / Concentrations:250 mg/kg bwBasis:nominal in diet
Remarks:
Doses / Concentrations:500 mg/kg bwBasis:nominal in diet
Remarks:
Doses / Concentrations:1000 mg/kg bwBasis:nominal in diet
No. of animals per sex per dose:
5 male and 5 females for each concentration
Control animals:
yes, concurrent no treatment

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Description (incidence and severity):
No mortality and no clinical signs were observed.
Mortality:
mortality observed, treatment-related
Description (incidence):
No mortality and no clinical signs were observed.
Details on results:
None of the mice died before the end of the studies. A malfunction of the watering system during the first week resulted in decreased water availability to male mice that received 500 or 1,000 mg/kg C.I. Acid Orange 3.This probably accounted for initial weight losses and overall decreased weight gains in these groups. Vehicle control female mice lost weight during the first week of the studies. All dosed groups had orange urine. All but two mice that received 1,000 mg/kg were inactive. No compound-related effects were observed at necropsy.

Effect levels

Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
mortality

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The value of NOAEL for repeated dose toxicity was established at 1000 mg/kg bw/day.
Executive summary:

The value of NOAEL for repeated dose toxicity was established at 1000 mg/kg bw/day.

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