Biphenyl-2-ol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27 Nov 1990 - 11 Dec 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Reference 2

Reference Type:

secondary source

Title:

O-Phenylphenol and its Sodium and Potassium Salts: A Toxicological Assessment

Author:

Bomhard, E. M. et al.

Year:

2002

Bibliographic source:

Crit. Rev. Toxicol. 32(6):551-626

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: 84/449/EEC (Gazette of the European Community, No. L 251, p. 103) (1984)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Biphenyl-2-ol

EC Number:

201-993-5

EC Name:

Biphenyl-2-ol

Cas Number:

90-43-7

Molecular formula:

C12H10O

IUPAC Name:

[1,1'-biphenyl]-2-ol

Test material form:

solid: crystalline

Details on test material:

Batch No.: Pa. 18

Specific details on test material used for the study:

- Stability under test conditions: Analytic investigations on the stability of the test compound in the vehicle were not carried out for logistic reasons and since there was only a short period of time between preparation and application.
- Storage condition of test material: at room temperature, dry

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: young adult
- Weight at study initiation:229 g (males) and 191 g (females)
- Fasting period before study: no
- Housing: individually in Makrolon Type-II cages on low-dust wood granules (Ssniff, Soest/Westphalia, Germany)
- Diet: fixed formula standard diet Altromin 1324 Pellets (Altrmin GmbH and Co KG, Lage, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2
- Humidity (%): 50±10
- Air changes (per hr): approximately 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

other: test substance was worked up into a paste using several drops of Cremophor E (non-ionic organic emulgator)

Details on dermal exposure:

TEST SITE
- Area of exposure: back and flanks
- % coverage: approximately 10% of the body surface
- Type of wrap if used: skin plaster (Fermoflexband, Beiersdorf AG, Germany)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with luke-warm water
- Time after start of exposure: 24 h

TEST MATERIAL
- Constant volume or concentration used: no (application volume for each animal was based on its body weight just prior to application)
- For solids, paste formed: yes

VEHICLE
- Amount(s) applied (volume or weight with unit): several drops

Duration of exposure:

24 h

Doses:

2000 mg/kg bw (Limit test)

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: several times on the day of administration, twice daily thereafter (once daily on weekends and holidays)
- Frequency of weighing: directly before administration (day 1), after 1 week and at study termination
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred throughout the study period.

Clinical signs:

other: other: There were no test material related signs of systemic toxicity noted throughout the study period. As a local skin change slight reddening was observed in males and females on the day after application, this redness turned to incrustation on day 5

Gross pathology:

There were no test material related changes noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

DSD: not classified
CLP: not classified