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Registration Dossier
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EC number: 416-250-2 | CAS number: 84632-59-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1993-05-13 - 1993-09-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD TG 406) performed under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted on 12th May 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- -
- EC Number:
- 416-250-2
- EC Name:
- -
- Cas Number:
- 84632-59-7
- Molecular formula:
- C26 H28 N2 O2
- IUPAC Name:
- 3,6-bis(4-tert-butylphenyl)-1H,2H,4H,5H-pyrrolo[3,4-c]pyrrole-1,4-dione
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White Strain (Tif: DHP)
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Limited; Animal Production; 4332 Stein / Switzerland
- Age at study initiation: No data
- Weight at study initiation: 327 - 406 g.
- Housing: Individually in Macrolon cages (Type 3)
- Diet and water: ad libitum standard guinea pig pellets and fresh water
- Acclimation period: at least 6 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 3 °C
- Humidity: 30 - 70 %
- Air changes: No data
- Photoperiod: 12 hours light cycle day
IN-LIFE DATES: From: 1993-05-25 To: 1993-07-01
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- petrolatum
- Concentration / amount:
- Intradermal induction: 5 % of test item in in Oleum arachidis (w/v);
Epidermal induction: 50 % test item in vaseline (w/w)
Epidermal challenge: 50 % test item in vaseline (w/w)
Epidermal rechallenge: 30 % test item in vaseline (w/w)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- Intradermal induction: 5 % of test item in in Oleum arachidis (w/v);
Epidermal induction: 50 % test item in vaseline (w/w)
Epidermal challenge: 50 % test item in vaseline (w/w)
Epidermal rechallenge: 30 % test item in vaseline (w/w)
- No. of animals per dose:
- 10 males /10 females in the test group,
5 males / 5 females in the control group - Details on study design:
- RANGE-FINDING TESTS
Pretests were performed for dose-level selection. Since 5 % test item in Oleum arachidis (w/v) could be injected and was well tolerated, this concentration was used for the intradermal induction. 50 % test item in vaseline (w/w) was the highest concentration for epidermal treatment. This concentration did not induce erythema reactions.
A. INDUCTION EXPOSURE
First induction, intradermal injection:
Three pairs of intradermal injections (0.1 mL per injection) were made simultaneously into the shaved neck of the guinea pigs as follows:
- adjuvant/saline mixture 1:1 (v/v)
- test article (5 %) in Oleum arachidis (w/v)
- test article (5 %) in the adjuvant/saline mixture 1:1 (w/v)
Second induction (one week later), epidermal application:
The test item (50 %) in vaseline (w/w) was applied on a filterpaper patch to the neck of the animals (0.4 g paste per patch; occluded administration for 48 hours).
The application sites were pretreated the day before with 10% sodium lauryl sulfate (open application).
Control group animals were treated identically in the absence of test item.
B. CHALLENGE EXPOSURE
Test and control group animals were treated (week 5) on the flank with the test item (50 %) in vaseline (w/w) and the vehicle alone (approx. 0.2 g paste per patch; occluded administration for 24 hours).
Skin reactions were scored 24 and 48 hrs after patch removal.
C. RECHALLENGE EXPOSURE
Because after the first challenge application reactions were observed in several animals of the control group a second challenge was performed. Test and control group animals were treated (week 6) on the flank with the test item (30 %) in vaseline (w/w) and the vehicle alone (approx. 0.2 g paste per patch; occluded administration for 24 hours). Skin reactions were scored 24 and 48 hrs after patch removal. - Positive control substance(s):
- yes
- Remarks:
- Potassium dichromate
Results and discussion
- Positive control results:
- The positive control item (tested at 0.2 % and 5 % during intradermal and topical induction, and 1 % during challenge) induced skin sensitising reactions in 90 % of the animals, indicating the sensitivity of the test system (Reference values with Potassiumdichromate, Test No. 920024, CIBA-GEIGY Ltd, 1992).
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50 %. No with. + reactions: 2.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50 %. No with. + reactions: 1.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 %. No with. + reactions: 8.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50 %. No with. + reactions: 4.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 30 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 30 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 30 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
After the first challenge application 10 and 40% of the animals of the test and control group showed skin reactions 24 and 48 hours after removal of the dressings, respectively. The reactions in the control group clearly indicate that the challenge concentration of 50 % exceeded the maximum non-irritating concentration. After a second challenge application, using the lower test item concentration of 30 %, none of the animals of the test group was sensitised and none of the animals of the control group showed skin reactions 24 and 48 hours after removing the dressings. The results of the re-challenge treatment confirm that the reactions seen after the first challenge were due to irritation and do not reflect an allergic response. Consequently, it is concluded in the study report that no animal of the test group was sensitised by the test item under the experimental condition employed. The test item is, therefore, considered as non-senitising.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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