Registration Dossier
Registration Dossier
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EC number: 485-350-6 | CAS number: 405095-33-2
Skin sensitisation
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:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- 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 substance name:
- -
- EC Number:
- 485-350-6
- EC Name:
- -
- Cas Number:
- 405095-33-2
- Molecular formula:
- C15H20N6O3
- IUPAC Name:
- Carbonic acid - 1-phenylguanidine (1:2)
- Test material form:
- solid: bulk
Constituent 1
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 chemical
- 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 chemical
- 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.
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