Registration Dossier
Registration Dossier
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EC number: 700-897-5 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Test carried out in 1988 prior to LLNA being formally adopted by OECD
Test material
- Reference substance name:
- Diisostearyl Malate
- IUPAC Name:
- Diisostearyl Malate
- Test material form:
- other: liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- propylene glycol
- Concentration / amount:
- Induction concentration: 5% in propylene glycol and freund's adjuvant
Challenge Concentration: 100%, 050% in petrolatum
Challengeopen allclose all
- Route:
- other: epicutaneous
- Vehicle:
- propylene glycol
- Concentration / amount:
- Induction concentration: 5% in propylene glycol and freund's adjuvant
Challenge Concentration: 100%, 050% in petrolatum
- No. of animals per dose:
- 10 animals/dose
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- Duration: the assay are run by applying a minimally irritating dose of the test substance to the shaved flanks of Dunkin-hartley guinea pigs for approximately 3 weeks.
- Concentrations: 5% in propylene glycol and freund's adjuvant
B. CHALLENGE EXPOSURE
- Concentrations: undiluted and 50% in petrolatum
- Evaluation (hr after challenge): 24 hr and 48 hr - Challenge controls:
- not included
- Positive control substance(s):
- not required
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test substance does not appear to be a sensitizer in the Dunkin-Hartley guinea pig.
- Executive summary:
Introduction
The ability of a chemical compound to induce an allergic contact dermatitis in the skin is determined by using guinea-pigs as animal models. Assays in which guinea pigs are exposed to potential allergenic chemicals include the Magnusson-Kligman Maximization Assay, and the Buehler Assay which is used it because it more closely mimics human exposure.
Induction phase
The assays are run by applying a minimally irritating dose of the test compound (5% propylene glycol and freund's adjuvant) the to the shaved flanks of Dunkin-Hartley guinea pigs for approximately 3 weeks.
Challenge phase
About 1x week after the last application, the undiluted chemical or 50% in petrolatum is re-applied to the animals.
Scoring of erythema and edema (24 and 48 hours) is accomplished by adding up all the animals that responded in a group of ten and expressing it as a percentage (incidence) and determined the intensity of teach response on a scale of 0-4.
Result
Scores of zero in all test animals were obtained at all time points examined. The test material does not appear to be a sensitizer in the guinea pig.
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