Registration Dossier
Registration Dossier
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EC number: 203-812-5 | CAS number: 110-88-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989-01-18 till 1989-02-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD) with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- (adopted 1981)
- GLP compliance:
- yes
- Remarks:
- (BASF AG, Department of Toxicology )
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 1,3,5-trioxane
- EC Number:
- 203-812-5
- EC Name:
- 1,3,5-trioxane
- Cas Number:
- 110-88-3
- Molecular formula:
- C3H6O3
- IUPAC Name:
- 1,3,5-trioxane
- Details on test material:
- - Name of test material (as cited in study report): Trioxan-Schuppen
- Physical state: solid, crystalline, white
- Analytical purity: 99.9%
- Storage condition of test material: room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Lippische Versuchstierzucht, Hagermann GmbH & Co.
- Weight at study initiation: 259-319 g
- Housing: 5 per cage
- Diet (e.g. ad libitum): Kliba 341.4 mm (Klingentalmühle AG, Kaiseraugst)
- Water (e.g. ad libitum): tap water, addition of about 2g ascorbic acid/10 L water twice every week
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- PRETEST
- The animals were exposed to about 0.15 g of the test substance formulation applied to the skin under occlusive conditions
MAIN TEST
- Intradermal induction: 5% test substance formulation in either aqua dest. or Freund's adjuvant/ aqua dest. (1:1)
- Epicutaneous induction: 50% test substance formulation in either aqua dest.
- First Challenge: 50% test substance formulation in either aqua dest.
- Second Challenge: 50% test substance formulation in either aqua dest.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- PRETEST
- The animals were exposed to about 0.15 g of the test substance formulation applied to the skin under occlusive conditions
MAIN TEST
- Intradermal induction: 5% test substance formulation in either aqua dest. or Freund's adjuvant/ aqua dest. (1:1)
- Epicutaneous induction: 50% test substance formulation in either aqua dest.
- First Challenge: 50% test substance formulation in either aqua dest.
- Second Challenge: 50% test substance formulation in either aqua dest.
- No. of animals per dose:
- 20 animals in the test group
10 animals in each of two control groups - Details on study design:
- PRETEST
- No. of exposures: 2 times for 24 hours within a period of 96 hours (about 0.15 g of the test substance formulation under occlusive condition)
- Exposure period: 24h
- Test groups: 4 animals per test concentration
- Site: Flank, second application on the same spot
- Frequency of applications: 24h after initial application, second application was administered
- Reading: about 24h and 48h after the begining of application (assessment of skin findings)
- Duration: 96h
MAIN STUDY
INDUCTION
Intradermal Application
- No. of exposures: 6 intradermal injections in groups of two per animal
- Exposure period: 24h
- Test groups: 20 animals
- Control group: 10 animals
- Site: Shoulder
- Frequency of applications: one time
- Concentrations: 2 injections each of 0.1 ml Freund's adjuvant without test substance emulsified with water (1:1) followed by 2 injections each of 0.1 ml of the test substance formulation, followed by 2 injections each of 0.1 ml Freund's adjuvant/water (1:1) with test substance in the test group. Control group were given the same injections but without test substance, only with the formulating agent.
Percutaneous Application
- Time of application: one week after intradermal application
- No. of exposures: single dermal application
- Exposure period: 48h
- Test groups: 20
- Control group: 10
- Site: Shoulder, same area as preceding intradermal application
- Frequency of applications: one time
- Concentrations: The test animals were exposed to about 50% test substance formulation in aqua dest (0.3 g of the test substance formulation) under an occlusive dressing. The control animals were treated since with distilled water in similar manner.
CHALLENGE
Two challenges were conducted:
- First challenge: treatment of the test group and of control group 1 with the test substance formulation (control group 2 remained untreated);
- Second challenge: treatment of the test group and of control groups 1 and 2 with the test substance formulation
- Day(s) of challenge: (first challenge: 14d after percutaneous exposure, second challenge: 7d after first challenge)
- Exposure period: 24h
- Test groups: 20
- Control group: 10
- Site: Intact clipped flank
- Concentrations: The test animals were exposed to about 50% test substance formulation in aqua dest under an occlusive dressing.
- Evaluation (hr after challenge): 24, 48 and 72h after begin of application - Challenge controls:
- 10 guinea pigs
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50% test substance in aqua dest.
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50% test substance in aqua dest.. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50% test substance in aqua dest.
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50% test substance in aqua dest.. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50% test substance in aqua dest.
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 50% test substance in aqua dest.. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50% test substance in aqua dest.
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 50% test substance in aqua dest.. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- No test substance application
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: No test substance application. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
Skin irritation findings during induction:
After intradermal induction, distinct erythema and edema were observed at the injection sites of both control and test animals, at which only Freund's adjuvant/aqua dest. (1:1) was applied. Injection of test substance preparation in aqua dest caused distinct erythema in the test animals. The application areas which were injected with test substance preparation in Freund's adjuvant/aqua dest. (1:1) exhibited distinct erythema and edema. The control animals injected with aqua dest. (vehicle) did not show any skin reactions.
Result of the maximization test:
No skin reactions could be observed in the control and treated groups after both, the first and the second challenge.
Applicant's summary and conclusion
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