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Registration Dossier
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EC number: 261-448-2 | CAS number: 58798-47-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 15 April to 22 May 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Method was not available
Test material
- Reference substance name:
- 2-[[(4-methoxyphenyl)methylhydrazono]methyl]-1,3,3-trimethyl-3H-indolium methyl sulphate
- EC Number:
- 258-946-7
- EC Name:
- 2-[[(4-methoxyphenyl)methylhydrazono]methyl]-1,3,3-trimethyl-3H-indolium methyl sulphate
- Cas Number:
- 54060-92-3
- Molecular formula:
- C20H24N3O.CH3O4S C21H27N3O5S
- IUPAC Name:
- 2-{[2-(4-methoxyphenyl)-2-methylhydrazin-1-ylidene]methyl}-1,3,3-trimethyl-3H-indol-1-ium methyl sulfate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Astrazon Goldgelb GL-E 200% micro
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: pirbright-white
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann, Gartenstraße 27, 33178 Borchen, Germany
- Age at study initiation: -
- Weight at study initiation: 339 g to 414 g
- Housing: 5 animals/group
- Diet (ad libitum): ssniff Ms-H V2233
- Water (ad libitum): tap water
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23
- Humidity (%): 30 to 70
- Air changes (per hr): -
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 15 April To: 22 May 1998
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Induction and Challenge: 0.5 g moistened with 0.5 mL deionized water
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Induction and Challenge: 0.5 g moistened with 0.5 mL deionized water
- No. of animals per dose:
- Determination of primary non-irritant concentration: 3
Control group: 10
Treatment group 20 - Details on study design:
- RANGE FINDING TESTS:
100 %, 20 %, 4 % (1000, 200, 40 mg/mL)
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours occlusive
- Test groups: 1000 mg/mL (0.5 mL) in deionized water
- Control group: 0.5 mL deionized water
- Frequency of applications: once/week
- Duration: Day 1 to 15
- Site: left flank
- Concentrations: 100 %
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 29
- Exposure period: 6 hours
- Test groups: 1000 mg/mL (0.5 mL) in deionized water
- Control group: 1000 mg/mL (0.5 mL) in deionized water
- Site: right flank
- Concentrations: 100 %
- Evaluation (hr after challenge): 24 and 48 hours after removal of patches - Challenge controls:
- NA
- Positive control substance(s):
- yes
- Remarks:
- alpha-hexyl cinnamic aldehyde in PEG 400
Results and discussion
- Positive control results:
- 30% positive = valid
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1000 mg/mL
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- skin surface orange discolored
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1000 mg/mL. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: skin surface orange discolored.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1000 mg/mL
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- skin surface orange discolored
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1000 mg/mL. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: skin surface orange discolored.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1000 mg/mL
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- skin surface orange discolored
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1000 mg/mL. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: skin surface orange discolored.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1000 mg/mL
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- skin surface orange discolored
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1000 mg/mL. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: skin surface orange discolored.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 20 %
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 20 %. No with. + reactions: 2.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 20 %
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 20 %. No with. + reactions: 1.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 20 %
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: positive control. Dose level: 20 %. No with. + reactions: 6.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 20 %
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: positive control. Dose level: 20 %. No with. + reactions: 5.0. Total no. in groups: 20.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Astrazon Goldgelb GL-E 200% micro showed no sensitizing properties in the Buehler test
- Executive summary:
Testing for sensitizing properties of Astrazon Goldgelb GL-E 200% was performed in female guinea pigs according to the method of BUEHLER.
Dermal induction was performed using 100 % Astrazon Goldgelb GL-E 200% moistened with deionized water.
Challenge treatment were carried out with 100 % Astrazon Goldgelb GL-E 200% moistened with deionized water.
The validity of the test system is confirmed by the periodically conducted positive control test using alpha-hexyl cinnamic aldehyde for the BUEHLER test (report number 98.0419, dated June 26, 1998; Hoechst Marion Roussel Deutschland GmbH, Drug Safety).
Under the conditions of the present study, none of twenty animals of the treatment group showed a positive skin response after the challenge procedure.
Based on the results of this study Astrazon Goldgelb GL-E 200% showed no evidence for sensitizing properties.
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