Biphenyl

Repeated dose toxicity: dermal

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

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

Test material information

Constituent 1

Reference substance name:

Biphenyl

EC Number:

202-163-5

EC Name:

Biphenyl

Cas Number:

92-52-4

Molecular formula:

C12H10

IUPAC Name:

1,1'-biphenyl

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 / concentrations

Doses / concentrations 1

Remarks:

Doses / Concentrations:
0.6 g/kg body weight
Basis:
nominal per unit body weight

Doses / concentrations 2

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.