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Toxicological information

Acute Toxicity: dermal

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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

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991
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 guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
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

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
- Name of test material (as cited in study report): Preventol o extra in Schuppen (in scales), 1,1'-Biphenyl-2-ol, o-Phenylphenol, sample number DZA-UER-8910180-A
- Molecular formula: C12H10O
- Molecular weight: 170.2 g/mol
- Physical state: white crystals
- Analytical purity: 99.89%
- Impurities (identity and concentrations): Diphenylether <0.003%, Dibenzofuran <0.005%, 2-Cyclohexylphenol 0.04%, ß-Naphthol <0.003%, -Phenylkresol 0.05%, 4-Phenylphenol 0.005%
- Purity test date: 04 Jul 1989
- Lot/batch No.: Pa. 18
- 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 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:
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 and was more severe on females than on males. On day 10 (males) and 14 (females) skin of all animals was normal.
Body weight:
There were no test material related effects on body weights noted in 5/5 males and 2/5 females throughout the study period. In 3/5 females, a slight decrease in body weights was noted, however, at study termination all animals had surpassed their initial body weights again.
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