Registration Dossier
Registration Dossier
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EC number: 419-370-3 | CAS number: 84632-66-6
Toxicological information
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995-01-04 to 1995-01-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 92/69/EEC, 31-Jul-1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted July 17, 1992
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Himalayan spotted
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wölferstrasse 4, 4414 Füllinsdorf/Switzerland
- Age at study initiation: 5 - 7 weeks
- Weight at study initiation: 317 - 427 g
- Housing: Individually in Makrolon type-3 cages with autoclaved standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz).
- Diet: Pelleted standard Kliba 342, batch no. 66/94 guinea pig breeding/maintenance diet ("Kliba", Klingentalmuhie AG, CH-4303 Kaiseraugst), ad libitum.
- Water: Community tap water from Füllinsdorf, ad libitum.
- Acclimation period: One week for the control and test group under test conditions after health examination.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- Humidity (%): 51-68
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1994-12-28 To: 1995-01-30
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: ethanol
- Concentration / amount:
- Induction:
intradermal: 5%
epidermal: 25%
Challenge:
epidermal: 25%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol
- Concentration / amount:
- Induction:
intradermal: 5%
epidermal: 25%
Challenge:
epidermal: 25%
- No. of animals per dose:
- Test group: 20
Control group: 10 - Details on study design:
- RANGE FINDING TESTS:
The objective of this investigation was to identify a maximally tolerated concentration of the test article suitable for the induction phase of the main
study. In addition, a suitable non-irritant concentration of the test article, by the topical route of administration, was identified for the challenge application.
MAIN STUDY
A.1 INDUCTION EXPOSURE -intradermal
- No. of exposures: one, on test day 1
- Exposure period: single treatment
- Test groups (2 injections each):
1) 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
2) The test article, diluted to 5% with ethanol.
3) The test article diluted to 5% by emulsion in a 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
- Control group (2 injections each):
1) 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
2) ethanol
3) 1:1 (w/w) mixture of ethanol in a 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
- Site: scapular region
- Concentration: 5 % in ethanol
A.2 INDUCTION EXPOSURE-epidermal
- No. of exposures: one
- Exposure period: start on test day 8 for 48 h
- Pretreatment: 10% Sodium-Lauryl-Sulfate (SLS)
- Test groups: 2 x 4 cm patch of filter paper was saturated with the test article (25% in ethanol)
- Control group: 2 x 4 cm patch of filter paper was saturated with the test vehicle (ethanol)
- Site: scapular area
- Concentration: 25 % in ethanol
B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day of challenge: performed on test day 22
- Exposure period: 24 h
- Test groups: Two patches ( 2 x 2 cm) of filter paper were saturated with the highest non-irritating concentration of 25% (left flank) and the vehicle only (right flank)
- Control group: same as test group
- Site: flank
- Concentration: 25 % in ethanol
- Evaluation (hr after challenge): 24 and 48 - Challenge controls:
- none
- Positive control substance(s):
- yes
- Remarks:
- 2-Mercaptobenzothiazol and Benzocaine
Results and discussion
- Positive control results:
- Following treatment (challenge) with 25% 2-Mercaptobenzothiazol or 25% Benzocaine in mineral oil 60% 60% of the animals were positive in the GPMT, indicating the sensitivity of the test system used for sensitisation assessment.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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