Registration Dossier
Registration Dossier
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EC number: 610-977-0 | CAS number: 53201-62-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996-12-18 until 1997-04-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study followed OECD Guideline unde GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Hydroquinone-bis-p-hydroxybenzoate (OH-Dreikerner)
- IUPAC Name:
- Hydroquinone-bis-p-hydroxybenzoate (OH-Dreikerner)
- Details on test material:
- - Name of test material (as cited in study report): Hydroquinone-bis-p-hydroxybenzoate (OH-Dreikerner)
- Physical state: solid powder
- Storage condition of test material: in original container, at room temperature, in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: 5-7 weeks
- Weight at study initiation: 412-539 g
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-3 °C
- Humidity (%): 40 - 70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 h dark, 12 h light
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- Intradermal injection: 5%
Epicutanous induction: 50%
Challenge application: 50%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Intradermal injection: 5%
Epicutanous induction: 50%
Challenge application: 50%
- No. of animals per dose:
- 10 in test and 5 in the control group
- Details on study design:
- RANGE FINDING TESTS:
done with 3 animals
MAIN STUDY
A. INDUCTION EXPOSURE
Intrdermal injection on day 1
Test Group: 3 Injections -> 1:1 mixture of Freunds Complete Adjuvant and physiol. sline; Testarticle dilluted to 5% with water; Test article dilluted to 5% with the 1:1 mixture of Freunds Complete Adjuvant and physiol. sline.
Control Group: 3 Injections -> 1:1 mixture of Freunds Complete Adjuvant and physiol. sline; water; 50 % water with the 1:1 mixture of Freunds Complete Adjuvant and physiol. sline.
Epidermal applications on day 8:
Preparation of the test site with sodiumlaurylsulfate on day 7
Test Group: Application of 50% test substance in waterr
Control Group: water
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 22
- Exposure period: 24 h
- Test groups: Application of 50% test substance in water on the left flank, water on the right flank
- Control group: Application of 50% test substance in water on the left flank, water on the right flank
- Site: shoulder region
- Evaluation (hr after challenge): 24, 48 - Positive control substance(s):
- yes
- Remarks:
- alpha Hexylcinnamicaldehyde in a separate study
Results and discussion
- Positive control results:
- The reliability control worked as expected. The test was prepared separately in Jan/Feb 1997 with .alpha.-Hexylcinnamicaldehyde.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0 and 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0 and 50%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0 and 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0 and 50%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 and 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0 and 50%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 and 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0 and 50%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The substance is not sensitizing to the skin in a OECD 406 Guinea Pig Maximation Test under the conditions used.
- Executive summary:
In order to assess the cutaneous allergenic potential of Hydroquinone-bis-p-hydroxybenzoate (OH-Dreikerner), the Maximization-Test in accordance with OECD Guidline 406 was carried out on male albino guinea pigs. In this study 0% of the animals of the test group were observed with postive skin reactions after the treatment with non irritant test article concentration of 50 % in bi-destilled water. No skin reactions were observed in the control group.
Therefore, the test article Hydroquinone-bis-p-hydroxybenzoate (OH-Dreikerner) is considered to be no sensitizer when used under the described test conditions.
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