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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
Study period:
1962
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Unknown purity, old and not very well described method, Not GLP

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1962
Report Date:
1962

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rat
Sex:
male/female

Administration / exposure

Route of administration:
oral: feed
Duration of treatment / exposure:
90 days
Frequency of treatment:
in diet
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:1% Basis:nominal in diet
Remarks:
Doses / Concentrations:5% Basis:nominal in diet
No. of animals per sex per dose:
10 at 1%, 5 at 5%
Control animals:
yes, plain diet

Results and discussion

Effect levels

Dose descriptor:
LOAEL
Effect level:
ca. 10 000 mg/kg diet
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: toxic effect in kidney and spleen

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
LOAEL < 10,000 mg/kg diet
Executive summary:

Ten male and ten female rats per group were exposed to C.I. Pigment Red 4 in the diet for 90 days at two concentrations of 5% and 1%. 

No rats died during the study. The general behavior of rats at 5% and 1% was not affected. The body weight gain was lower in the 5% group compared to controls for male rats. Body weight gain of female rats at 5% concentration of test substance in the diet were not affected.

The histological examination of the organs did show some signs of changes related to the experiment in the kidney and spleen when exposed to 1% of C.I. Pigment Red 4 and more prominently at 5%.