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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1984/1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP guideline study with some deviations from current guideline

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Contact allergy to chlorocresol, formaldehyde and other biocides.
Author:
Andersen, K.E.
Year:
1986
Bibliographic source:
Acta Dermato-Verereologica, Supplementum 125, pp. 2-21.
Reference Type:
publication
Title:
Unnamed
Year:
1984
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
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
some reporting deficits, no appropriate positive control
GLP compliance:
no
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: granules
Details on test material:
- Name of test material (as cited in study report): Preventol o extra, Dowicide I, o-phenylphenol
- Physical state: white granules
- Analytical purity: > 99.5%
- Other: information presented is as given from supplier

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: outbred albino guinea pigs (Ssc: Al)
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Statens Seruminstitute
- Weight at study initiation: 350-450 g
- Housing: in plastic cages
- Diet: standard diet, ad libitum
- Water: with vitamin C enriched, ad libitum
- Acclimation period: 1 week

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: propylene glycol (PG) for the intradermal induction; for induction and challenge patch tests yellow petroleum was used
Concentration / amount:
1st application: Induction 0.5 or 5 % intradermal injection
2nd application: Induction 25 % occlusive epicutaneous
3rd application: Challenge 5 % occlusive epicutaneous
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: propylene glycol (PG) for the intradermal induction; for induction and challenge patch tests yellow petroleum was used
Concentration / amount:
1st application: Induction 0.5 or 5 % intradermal injection
2nd application: Induction 25 % occlusive epicutaneous
3rd application: Challenge 5 % occlusive epicutaneous
No. of animals per dose:
20 for both control and test groups
Details on study design:
RANGE FINDING TESTS:
The concentration used for induction and challenge were determined in a minimum of 4 guinea pigs. For these one application irritancy tests animals were treated with FCA/vehicle (1:1) intradermal injections in the postnuchal area 3-5 weeks prior to the irritancy test. For intradermal and topical induction, a moderately irritant concentration was chosen. For challenge a non-irritant concentration and dilutions thereof were used.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous)
- Test groups:
Intradermal injection: FCA was emulsified with vehicle or test material (1:1 v/v) (not further specified)
Epicutaneous induction: 0.5 mL test material on filter paper mounted on Leucoflex sealed with Acrylastic
- Control group:
The control animals were treated as the test animals but with the vehicle only (not further specified)
- Concentrations: 0.5 or 5% intradermal injections; 25% epicutaneous

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 21
- Exposure period: 48 h
- Test groups: 0.5 mL test material in Finn Chambers on Scanpor sealed with Acrylastic.
- Control group: The control animals were treated as the test animals (not further specified)
- Site: flanks
- Concentrations: 5%
- Evaluation (hr after challenge): 48 h

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
other: test group induced with 0.5% intradermal injection annd 25% epicutaneous application
Dose level:
5%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: other: test group induced with 0.5% intradermal injection annd 25% epicutaneous application. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
48
Group:
other: test group induced with 5% intradermal injection annd 25% epicutaneous application
Dose level:
5%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: other: test group induced with 5% intradermal injection annd 25% epicutaneous application. Dose level: 5% . No with. + reactions: 0.0. Total no. in groups: 20.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified