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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:
November 1992 - January 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
This study has been performed in compliance with Good Laboratory Practice (GLP) in Switzerland, Procedures and Principles, March 1986, issued by the Federal Department of the Interior and the Intercantonal Office for the Control of Medicaments, Switzerlan
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Test was performed befor LLNA became the first joice test.

Test material

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

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male/female

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Concentration / amount:
Intradermal Induction: 0.1 mL per injection - concentration: 1% in physiological saline
Epidermal Applications:
Epidermal induction: 0.4g paste per patch - concentration: 50% in vaseline
Epidermal challenge: 0.2g paste per patch - concentration: 50% in vaseline
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Concentration / amount:
Intradermal Induction: 0.1 mL per injection - concentration: 1% in physiological saline
Epidermal Applications:
Epidermal induction: 0.4g paste per patch - concentration: 50% in vaseline
Epidermal challenge: 0.2g paste per patch - concentration: 50% in vaseline
No. of animals per dose:
Test group: 20 animals (10male, 10 female)
Control group:10 animals (5 male/5 femlae)

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
test group
Dose level:
0.2 g
No. with + reactions:
7
Total no. in group:
20
Clinical observations:
slight to well defined erythema, very slight edema
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 0.2 g. No with. + reactions: 7.0. Total no. in groups: 20.0. Clinical observations: slight to well defined erythema, very slight edema.
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
test group
Dose level:
0.2 g
No. with + reactions:
11
Total no. in group:
20
Clinical observations:
slight to well defined erythema, very slight edema
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 0.2 g. No with. + reactions: 11.0. Total no. in groups: 20.0. Clinical observations: slight to well defined erythema, very slight edema.
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
rechallenge
Hours after challenge:
24
Group:
positive control
Dose level:
1% in vaseline
No. with + reactions:
9
Total no. in group:
10
Clinical observations:
well defined erythema, slight edema
Reading:
rechallenge
Hours after challenge:
48
Group:
positive control
Dose level:
1% in vaseline
No. with + reactions:
9
Total no. in group:
10
Clinical observations:
well defined erythema, slight edema

Any other information on results incl. tables

Observations and records

Induction reactions

After the intradermal and the epidermal induction application irritant reactions are normally induced by the adjuvant, the high test article concentration, ort he sodium lauryl sulfate pretreatment. Because most of the reactions are treatment related and not compound related, the reactions are only related and not compound related, the reactions are only described in special cases in the section of results.

Challenge reactions

Twenty four and forty eight hours after removing the dressings, the challenge reactions were graded according to the Draize scoring scale.

General

The sensitising potential of CA 1139 A was classified according to the grading of Magnussen and Kligman.

The body weight was recorded at start and end of the test.

Remarks on results

Under the experimental conditions employed, 35 and 55% of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings, respectively.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
Under the experimental conditions employed, 35 and 55% of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings, respectively. CA 1139 A is, therefore, classified as a moderate sensitiser in albino guinea pigs to the grading of Magnussen and Kligman.
Executive summary:

The study was cariied under the rules of GLP.

This skin sensitisation test in the guinea pig test was conducted according to the OECD Guideline No. 406, adopted on May 12, 1981, adapted July 17, 1992, by the OECD council, and on Annex V, Part B of Council Directive 79/831/EEC (Commission Directive 84/449/EEC od April 25, 1984). Under the experimental conditions employed, 35 and 55% of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings, respectively. According to the maximisation grading CA 1139 A showed a moderate grade of skin-sensitising (contact allergenic) potential in abino guinea pigs.

CA 1139 A is, therefore, classified as a moderate sensitiser in albino guinea pigs to the grading of Magnussen and Kligman.