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Toxicological information

Repeated dose toxicity: dermal

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Administrative data

Endpoint:
short-term repeated dose toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Pre-guideline study with insufficient data to evaluate effects of substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1953
Report Date:
1953

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)
Deviations:
yes
Remarks:
exposure period 6 weeks, 1 rabbit per sex per dose exposed, abdominal area exposed, 2 doses tested, no clinical chemistry or hematology performed, histopathology onlyt performed on applicatino site and nearby tissues.
GLP compliance:
no
Remarks:
Study conducted prior to GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Diphenyl
- Physical state: colorless crystalline solid
- Analytical purity: not specified in the report
- Impurities (identity and concentrations): not specified in the report
- Composition of test material, percentage of components: not specified in the report
- Isomers composition: not specified in the report
- Purity test date: not specified in the report
- Lot/batch No.: not specified in the report
- Expiration date of the lot/batch: not specified in the report
- Stability under test conditions: not specified in the report
- Storage condition of test material: not specified in the report
- Source: Monsanto Chemical Company, St. Louis, MO, USA

Test animals

Species:
rabbit
Strain:
not specified
Sex:
male/female

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
6 weeks
Frequency of treatment:
5 days per week for 8 hours per day.
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
0.6 g/kg body weight
Basis:
nominal per unit body weight
Remarks:
Doses / Concentrations:
2 g/kg body weight
Basis:
nominal per unit body weight
No. of animals per sex per dose:
1 male + 1 female
Control animals:
yes, sham-exposed

Results and discussion

Effect levels

Dose descriptor:
other: insufficient data to establish a NOAEL
Sex:
male/female
Basis for effect level:
other: There were no effects on the body weight nor any evidence of irritation or sensitivity. Histopathological examination of the treated skin areas revealed no abnormalities.
Remarks on result:
not measured/tested
Remarks:
Effect level not specified (migrated information)

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

Body weight (increase) was normal. No signs of irritation or sensitivity.

All tissued appeared normal upon autopsy. Histopathology: no effects in internal organs nor in the treated skin and the tissues immediately beneath application site.

Applicant's summary and conclusion

Conclusions:
The application of diphenyl to the intact skin of adult rabbits for a period of six weeks (30 applications) resulted in no effects on the body weight nor was there any evidence of irritation or sensitivity. Histopathological examination of the treated skin areas revealed no abnormalities.