Registration Dossier
Registration Dossier
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EC number: 235-911-4 | CAS number: 13040-19-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July to September 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Zinc diricinoleate
- EC Number:
- 235-911-4
- EC Name:
- Zinc diricinoleate
- Cas Number:
- 13040-19-2
- Molecular formula:
- C18H34O3.1/2Zn
- IUPAC Name:
- zinc bis(12-hydroxyoctadec-9-enoate)
- Reference substance name:
- 9-Octadecenoic acid, 12-hydroxy-, zinc salt (2:1)
- IUPAC Name:
- 9-Octadecenoic acid, 12-hydroxy-, zinc salt (2:1)
- Reference substance name:
- Zinc ricinoleate
- IUPAC Name:
- Zinc ricinoleate
Constituent 1
Constituent 2
Constituent 3
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
-Strain: DHPW (SPF)
-Source: Firma Winkelmann Versuchstierzucht, D-4799 Borchen
- Age at study initiation: -
- Weight at study initiation: 267g - 338g
- Housing: macrolon cage type VI
- Diet (e.g. ad libitum): Sniff, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5 C° +- 3.5 C°
- Humidity (%): 50 - 85 %
- Air changes (per hr): -
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: water for intradermal, petrolatum for epicutaneous
- Concentration / amount:
- intradermal 5 % in water, epicutaneous induction 25 % in petrolatum, challenge 25 % in petrolatum.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: water for intradermal, petrolatum for epicutaneous
- Concentration / amount:
- intradermal 5 % in water, epicutaneous induction 25 % in petrolatum, challenge 25 % in petrolatum.
- No. of animals per dose:
- 10 male, 10 female (test group)
10 male, 10 female (control group) - Details on study design:
- RANGE FINDING TEST: 2 animals for intradermal, 2 animals for epicutaneous
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:2 (day1 intradermal, Day7 epicutaneous)
- Test group: 10 male, 10 female
- Control group: 10 male, 10 female
- Concentrations: 5 % in water (intradermal), 25 % in petrolatum (epicutaneous)
- Pretreatment with 10 % sodium lauryl sulfate before epicutaneous induction
B. CHALLENGE EXPOSURE
- No. of exposures: one
- Test group: 10 male, 10 female
- Control group: 10 male, 10 female
- Concentrations: 25 % in petrolatum
- Evaluation (hr after challenge): 24h und 48h after patch removal - Positive control substance(s):
- yes
- Remarks:
- 2,4 dinitrochlorobenzene, the last periodic use of the positive control substance with the acceptable level of response in the test animals was performed on April 5, 1990.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none mentioned
- 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. Clinical observations: none mentioned.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none mentioned
- 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: 20.0. Clinical observations: none mentioned.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none mentioned
- 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. Clinical observations: none mentioned.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none mentioned
- 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: 20.0. Clinical observations: none mentioned.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No animal showed an allergic response, the test substance is not sensitising
- Executive summary:
The test substance is a fine white powder and was tested regarding its skin sensitisation potential according to the stringent protocol of Magnusson and Kligman, in which adjuvant is used to elicit an immunologic reaction. The test protocol is in compliance with the OECD Guideline for the Testing of Chemicals No. 406 Skin Sensitisation.
The maximum compatible doses were determined in a pilot experiment. In the main experiment the test group of ten male and ten female guinea pigs of the strain "Dunkin Hartley" were treated intradermally with 0.1 ml of a 5 % concentration of the test substance in water; for the epicutaneous induction 25 % test substance in petrolatum was used. Because the test substance was not irritating at all tested concentrations, the treatment area was pretreated with 10 % sodium lauryl sulfate in petrolatum. A control group of further 10 male and 10 female animals were treated similarly – with the exception that they received only the vehicle instead of the test substance.
On day 21 of the application period the challenge application was performed on all control and test group animals. Again a 25 % concentration of the test substance in petrolatum was used. No symptoms of systemic toxicity or other toxic reactions were observed at any time during the study. Body weight development of the animals was positive and within normal ranges.
In the challenge no visible changes of the skin (no erythema and no edema) were observed in the test group and in the control group at any time point; i.e. there was no positive challenge result. Thus, the sensitisation rate was 0 %.
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