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Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
toxicity to reproduction
Remarks:
other: testicular observation (after ingestion of capsules)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data have been obtained from secondary source.

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
Toxicological Profile for dinitrophenol
Author:
M. Olivia Harris, M.A; James J. Corcoran, Ph.D. (peer rewied by Dr. martin Alexander; Dr.Leon Koller; Dr.Norman Trieff)
Year:
1995
Bibliographic source:
U.S Department of Health and Human Services, Public Health Service Agency for Toxic Substances and Disease Registry
Reference Type:
review article or handbook
Title:
1934b. Di-nitrophenol. Studies of blood, urine, and tissues of dogs on continued medication and after acute fatal poisoning.
Author:
Tainter ML, Cutting WC, Wood DA, et al.
Year:
1934
Bibliographic source:
Arch Pathol 18:881.

Materials and methods

Principles of method if other than guideline:
The method was based on an exposure to dogs via capsules of 2,4-dinitrophenol for six months. No further details were specified.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
other: dog
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
other: capsules
Duration of treatment / exposure:
six months
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
5 mg/kg/day
Basis:
other: in capsules
Remarks:
Doses / Concentrations:
10 mg/Kg/day
Basis:
other: in capsules
No. of animals per sex per dose:
3 per dose group

Results and discussion

Results: P0 (first parental animals)

Effect levels (P0)

Dose descriptor:
NOAEL
Effect level:
10 other: capsules
Sex:
male

Overall reproductive toxicity

Reproductive effects observed:
not specified

Any other information on results incl. tables

No gross histological evidence of treatment-related testicular damage was reported following 2,4-dinitrophenol at 5 or 10 mg/Kg/day.

Applicant's summary and conclusion

Conclusions:
No gross histological evidence of treatment-related testicular damage was reported following 2,4-dinitrophenol at 5 or 10 mg/Kg/day.
Executive summary:

Data have been obtained from secondary source that mentions Tainter ML, Cutting WC, Wood DA, et al. 1934b. Di-nitrophenol. Studies of blood, urine, and tissues of dogs on continued medication and after acute fatal poisoning. Arch Pathol 18:881. The method was based on an exposure to dogs via capsules of 2,4-dinitrophenol for six months. No further details were specified.

Testicular tissue vas histologically analysed after the 2,4 -dinitrophenol exposure and no gross histological evidence of treatment-related testicular damage. No gross histological evidence of treatment-related testicular damage was reported following 2,4-dinitrophenol at 5 or 10 mg/Kg/day.