Registration Dossier

Toxicological information

Repeated dose toxicity: oral

Currently viewing:

Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Other substances present in the test material might have contributed to the observed effects

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 407 (Repeated Dose 28-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
Details on test material:
Purity: 97.0%
1.5% Talgfett-propylendiamin (CAS# 61791-55-7 ???)
1.5% Dimethylcocosfettaminoxyd (CAS# ?)

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: feed
Duration of treatment / exposure:
32 days
Frequency of treatment:
daily in diet
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
0.2% (w/w) = 2,000ppm
Basis:
nominal in diet
Remarks:
Doses / Concentrations:
1.0% (w/w) = 10,000 ppm
Basis:
nominal in diet
Remarks:
Doses / Concentrations:
2.5% (w/w) = 25,000ppm
Basis:
nominal in diet
No. of animals per sex per dose:
10
Control animals:
yes, plain diet

Results and discussion

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
<= 10 000 mg/kg diet
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: Overall behavior and body weight
Dose descriptor:
NOAEL
Effect level:
< 2 000 mg/kg diet
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: Changes in blood samples
Remarks on result:
not determinable
Remarks:
no NOAEL identified

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Executive summary:

Ten male and ten female SPF-Wistar rats per group were exposed to C.I. Pigment Orange 5 in the diet for 32 days at three concentrations of 2.5%, 1% and 0.2%.

 

At the highest test concentration (2.5%) 7 male and 3 female rats died with the signs of severe weight loss. The general behavior of rats at 1 and 0.2% was not affected. The body weight gain was linked with a dose-dependence to the test substance. Only female rats at 0.2% concentration of test substance in the diet was not affected.

 

Tests of blood samples showed lower hemoglobin level, decrease in erythrocyte and leukocyte increase at all three test concentrations compared with the control group. The urine examination revealed no pathological findings.

 

The histological examination of the organs did not show any clear signs of changes related to the experiment. Only the iron content in the spleen appears to be slightly elevated in all experimental groups compared to the control group. The effect was not dose related.

Infiltrates of lymphocytes in liver and kidney are to be interpreted as non-specific response to unspecified identifiable stimulus and was not dose related.

The macroscopic and microscopic examination of the organs of the rats showed a remarkable weight loss of the animals at the highest test exposure concentration (2.5%) and a small increase of the iron content in the spleen of all animals.