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EC number: 431-060-1 | CAS number: 153719-38-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September - October 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study; documentation sufficient for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1996
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 was performed in compliance with Good Laboratory Practice (GLP) in Switzerland, Procedures and Principles, March 1986. These procedures are based on the OECD Principles of GLP, adopted May 12, 1981 by Decision of the OECD Council C(81)30(Final)
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- -
- EC Number:
- 431-060-1
- EC Name:
- -
- Cas Number:
- 153719-38-1
- Molecular formula:
- C4H8N4O3
- IUPAC Name:
- 3-methyl-N-nitro-3,6-dihydro-2H-1,3,5-oxadiazin-4-amine
- Details on test material:
- - Name of test material (as cited in study report): CA 2343 A
- Substance type: Intermediate of CGA 293343
- Physical state: fine, white powder
- Analytical purity: 96.7 %
- Lot/batch No.: P.503005
- Storage condition of test material: 0 - 5 °C
- Reanalysis date: August 16, 1995
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Ciba-Geigy Limited, Laboratory Animal Breeding, Pharma Division, 4332 Stein, Switzerland
- Weight at study initiation: 323 - 406 g
- Housing: individually in Macrolon cages (type 3)
- Diet (e.g. ad libitum): ad libitum standard guinea pig pellets from NAFAG 845, NAFAG, Gossau/SG, Switzerland
- Water (e.g. ad libitum): ad libitum, drinking water fulfills th ecritical parameters in the specifications of the "Schweizerisches Lbensmittelbuch" (Edition 1972)
- Acclimation period: September 13, 1995
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 °C +- 3 °C
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12 hrs
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- peanut oil
- Concentration / amount:
- 0.1 ml per injection
Test group:
adjuvant/physiological saline mixture 1:1 (v/v)
1% CA 2343 A in peanut oil
1% CA 2343 A in the adjuuvant/physiological saline mixture 1:1 (w/v)
Control group
adjuvant/physiological saline mixture 1:1 (v/v)
adjuvant/physiological saline mixture 1:1 (v/v)
peanut oil
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- peanut oil
- Concentration / amount:
- 0.1 ml per injection
Test group:
adjuvant/physiological saline mixture 1:1 (v/v)
1% CA 2343 A in peanut oil
1% CA 2343 A in the adjuuvant/physiological saline mixture 1:1 (w/v)
Control group
adjuvant/physiological saline mixture 1:1 (v/v)
adjuvant/physiological saline mixture 1:1 (v/v)
peanut oil
- No. of animals per dose:
- test group: 20
control group: 10 - Details on study design:
- RANGE FINDING TESTS:
Intradermal Induction:
- Vehicle: peanut oil
- Concentrations tested: 1, 3, and 5 % (w/v) in peanut oil
- Evaluation (hours): 24
Epidermal Applications (induction and challenge)
- Number of animals: 2
- Control group: 2 animals (same animals, tested with adjuvant/saline mixture 1:1 on shaved neck before application of CA 2343 A)
- Vehicle: vaseline
- Concentrations tested: 10, 30, and 50 % (w/v) in vaseline
- Evaluation (hours): 24
- Site: flank
- Evaluation (hr after challenge): 24 and 48 hours
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 22 days
- Test groups: 3
- Control group: 3
- Site: shaved neck
- Frequency of applications: day 0 and day 8
- Duration: day 0 = intradermal injection; day 8 epidermal application = 48 hours
- Concentrations: 1% CA 2343 A
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 22
- Exposure period: 24 hours
- Test groups: 3
- Control group: 3
- Site: both flanks
- Concentrations: 10% CA 2343 A in vaseline with a volume per chamber of 0.35 ml
- Evaluation (hr after challenge): 24 and 48 hours - Challenge controls:
- Naive skin sites served as control in the Pretests.
Main Study:
- Control Group: 5 males and 5 females - Positive control substance(s):
- not specified
Study design: in vivo (LLNA)
- Positive control substance(s):
- mercaptobenzothiazole (CAS No 149-30-4)
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no irritant skin reactions
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no irritant skin reactions.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no irritant skin reactions
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no irritant skin reactions.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% in vaseline (0.4 g per patch)
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Clinical observations:
- Very slight erythema reactions
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50% in vaseline (0.4 g per patch). No with. + reactions: 6.0. Total no. in groups: 20.0. Clinical observations: Very slight erythema reactions.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50% in vaseline (0.4 g per patch)
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Clinical observations:
- Very slight erythema reactions
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50% in vaseline (0.4 g per patch). No with. + reactions: 4.0. Total no. in groups: 20.0. Clinical observations: Very slight erythema reactions.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no irritant skin reactions
- 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: 10.0. Clinical observations: no irritant skin reactions.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no irritant skin reactions
- 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: 10.0. Clinical observations: no irritant skin reactions.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- The sensitization rate was 30% including transient irritant reactions.
Oxadiazinamine is graded as a moderate sensitiser according to Magnussen and Kligman (Appendix 2). - Executive summary:
This study was performed in compliance with Good Laboratory Practice (GLP) in , Procedures and Principles, March 1986. These procedures are based on the OECD Principles of GLP, adopted May 12, 1981 by Decision of the OECD Council C(81)30(Final).
The study has been conducted according to OECD guideline 406 adopted July 17, 1992, by the OECD council, and on Annex V, part B of Council Directive 67/548/EEC (Commission Directive 92/69/EEC of July 31, 1992).
A guinea pig maximisation test was initiated to determine sensitising properties of CA 2343 A (Intermediate of CGA 293343) after challenge exposure by skin contact. The procedure of Magnussen and Kligman for adjuvant tests was followed.
Epidermal challenge of 10 male and 10 female guinea pigs (test groups) resulted in positive responses in 6 (3 males, 3 females) animals after 24 hours and in 4 (2 males, 2 females) animals after 48 hours. Very slight erythema reactions in 1 male and 1 female faded after the scoring at 24 hours and were recognised as transient irritation (false-positive reaction) based on clinical appearance and duration. Scaling was recorded in 2 male animals (No. 126 and 134) after 48 hours. No irritant skin reactions were recorded for control animals. The sensitization rate was 30% including transient irritant reactions.
Body weights were recorded at start and on conclusion of the test and tabulated with means and standard deviations. Body weights were not affected by the treatment.
Based on the sensitization rate of 30% including transient irritant reactions, which is at the threshold of significance set in Commission Directive 93/21/EEC (18thadaptation to technical progress of Council Directive 67/548/EEC), CA 2343 A (Intermediate of CGA 293343) has to be labelled “May cause sensitization by skin contact”.
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