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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:
From 17 July to 10 August 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study run to a reliable method but not to GLP and no guideline followed

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The maximisation test comprises 2 procedures. The induction procedure consists of an intradermal injection of the test material followed after 7 days by a topical application. The challenge procedure, which consists of a topical application is carried out 21 days after commencement of the induction procedure.
GLP compliance:
not specified
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Porcellus Animals Limited
- Weight at study initiation: 350-400 g
- Housing: For each of the 3 tests, 25 test group animals were allocated equally into 5 cages, 10 control group animals were allocated equally in 2 cages and 2 dose finding animals were housed in a single cage. The cages had a grid floor beneath which was a peat moss filled tray.
- Diet (e.g. ad libitum): The animals were fed on BP Nutrition FD1 Diet, supplemented with hay. They were allowed food ad libitum.
- Water (e.g. ad libitum): They were allowed water ad libitum.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C (extremes of 18°C-24°C)
- Humidity (%): 63% (extremes of 52%-74%)

No additional data

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: distilled water in induction procedure and paraffin oil in challenge procedure
Concentration / amount:
Injection phase: 6.67% w/v
Topical induction: 60% w/v
Challenge procedure: 60% and 30% w/v
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: distilled water in induction procedure and paraffin oil in challenge procedure
Concentration / amount:
Injection phase: 6.67% w/v
Topical induction: 60% w/v
Challenge procedure: 60% and 30% w/v
No. of animals per dose:
25 guinea pigs
Details on study design:
RANGE FINDING TESTS: A maximum non-irritant concentration of test substance, p-Phenylenediamine and sodium lauryl sulphate was determined each in a pair of guinea pigs, hitherto treated with 2 injections of Freunds Complete Adjuvant only. The test materials were applied at a series of concentrations to the shaved flanks of the guinea pigs under the same occlusive patch system used for the topical induction. The test substance was tested at 60% and 30% w/v in paraffin oil.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Once (injection) and once (topical)
- Exposure period: Single injection and topical 48 hours
- Test groups: 6.67% w/v in distilled water in injection phase, 60% w/v in distilled water in topical induction.
- Control group: Positive control: p-Phenylenediamine 2% w/v in distilled water in injection phase and topical induction. Negative control: Sodium lauryl sulphate 1% w/v in distilled water in injection phase and topical induction.
- Site: Scapular region for injection phase and torso for topical induction.
- Frequency of applications: Topical followed one week after injection
- Duration: 3 weeks
- Concentrations: Injection phase: 6.67% w/v, Topical induction: 60% w/v

B. CHALLENGE EXPOSURE
- No. of exposures: Once
- Day(s) of challenge: Two weeks after the topical induction
- Exposure period: 24 h
- Test groups: 60% w/v in paraffin oil
- Control group: Positive control: p-Phenylenediamine 2% w/v in distilled water. Negative control: Sodium lauryl sulphate 0.5% w/v in distilled water.
- Site: Left flank
- Concentrations: 60% w/v
- Evaluation (hr after challenge): 24 hours

No additional data
Challenge controls:
The control guinea pigs which were pre-treated with Adjuvant only at the injection phase, were included to check on the irritancy of the test materials at the challenge concentration.
Positive control substance(s):
yes
Remarks:
p-Phenylenediamine

Results and discussion

Positive control results:
After being challenged with p-Phenylenediamine at a concentration of 2% w/v in distilled water, 24/25 test group animals showed moderate and confluent erythema while 1/25 test group animals showed slight erythema.
None of the control group animals showed erythema when challenged with p-Phenylenediamine at a concentration of 2% w/v in distilled water, so supporting the dose ranging results that at that concentration the test material would be non-irritant.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
60% w/v
No. with + reactions:
0
Total no. in group:
25
Clinical observations:
None
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 60% w/v. No with. + reactions: 0.0. Total no. in groups: 25.0. Clinical observations: None.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
2% w/v
No. with + reactions:
25
Total no. in group:
25
Clinical observations:
None
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 2% w/v. No with. + reactions: 25.0. Total no. in groups: 25.0. Clinical observations: None.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.5% w/v
No. with + reactions:
0
Total no. in group:
25
Clinical observations:
None
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.5% w/v. No with. + reactions: 0.0. Total no. in groups: 25.0. Clinical observations: None.

Any other information on results incl. tables

Preliminary tests indicated that the test substance should be non-irritant at a concentration of 60% w/v in paraffin oil on adjuvant pre-treated guinea pigs when applied to the shaved flank under occlusion.

The test substance did not elicit positive responses in the test group after challenge of the 25 guinea pigs by topical application.

The test substance was tested at the challenge phase on 10 guinea pigs which were Adjuvant pre-treated only.

None of these irritancy control group animals reacted positively to this topical application, so supporting the dose ranging results that at a concentration of 60% w/v in paraffin oil this test material would be non-irritant.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
There was no evidence from the Magnusson-Kligman Maximisation test to suggest that the test substance is a sensitiser in guinea pigs.