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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
repeated dose toxicity: oral
Remarks:
other: not reported
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
review article or handbook
Title:
The effect of carbon black ingestion on 1,2-dimethylhydrazine- induced colon carcinogenesis in rats and mice.
Author:
Pence, B.C. & Buddingh, F.
Year:
1985
Bibliographic source:
The effect of carbon black ingestion on 1,2-dimethylhydrazine- induced colon carcinogenesis in rats and mice. Toxicol. Lett., 25, 273-277

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 452 (Chronic Toxicity Studies)
Deviations:
not specified
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: pellets

Test animals

Species:
mouse
Strain:
not specified
Sex:
female

Administration / exposure

Route of administration:
oral: feed
Duration of treatment / exposure:
2 years
No. of animals per sex per dose:
31 and 28 animals with doses 0 and 2.05 g/kg diet

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
Details on results:
Survival was not affected.

No increase in tumour incidence was observed

Effect levels

open allclose all
Key result
Dose descriptor:
dose level: 2.05 g/kg
Effect level:
>= 2 050 - <= 2 050 mg/kg diet
Based on:
test mat.
Sex:
female
Basis for effect level:
clinical signs
Remarks on result:
not determinable due to absence of adverse toxic effects
Key result
Dose descriptor:
dose level: 2.05 G/kg diet
Effect level:
>= 2 050 - <= 2 050 mg/kg diet
Based on:
test mat.
Sex:
female
Basis for effect level:
mortality
Remarks on result:
not determinable due to absence of adverse toxic effects

Target system / organ toxicity

Key result
Critical effects observed:
no
System:
gastrointestinal tract

Any other information on results incl. tables

Survival was not affected. No increase in tumour incidence was observed

Applicant's summary and conclusion

Conclusions:
Carbon black is not classified as target organ toxicant via oral exposure route.
Executive summary:

Survival of mices is not affected by repeated oral absorption of carbon black.

No tumour incidence.