Registration Dossier
Registration Dossier
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EC number: 945-205-4 | CAS number: -
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: basic data given
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- Induction was performed by intradermal injection followed by 24 h treatment with 10% SDS and occlusive dermal application for 48 hours after 7 days. Two weeks after completion of sensitisation, challenge was performed with an occlusive dressing for 24 hours. Twenty four hours after completion of application of the closed patch, the site of skin was examined grossly.
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A non-LLNA test is available that was performed prior to the current data requirements, stipulated in Regulation (EC) No 1907/2006. In accordance with the same Regulation, the data was included to avoid unnecessary testing.
Test material
- Reference substance name:
- Automatically generated during migration to IUCLID 6, no data available
- IUPAC Name:
- Automatically generated during migration to IUCLID 6, no data available
- Details on test material:
- - Name of test material (as cited in study report): Zeolite S-D
- Related CAS number: 1318-02-1
- Chemical name: Zeolite, silica rich, crystalline, synthetic, non-fibrous
- Framework: orthorhombic
- Analytical purity: 99.4wt%
- Impurities: 0.79wt% Al203, <0.01% Na2O, 11.6% L0I
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Japan Laboratory Animals Inc.
- Weight at study initiation: 300 - 376 g
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- olive oil
- Concentration / amount:
- intradermal induction: 3.0% w/v
dermal induction: 25 % w/v
challenge: 40% w/v
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- olive oil
- Concentration / amount:
- intradermal induction: 3.0% w/v
dermal induction: 25 % w/v
challenge: 40% w/v
- No. of animals per dose:
- 15 were treated (induction), 5 served as controls (no induction, only challenge)
- Details on study design:
- RANGE FINDING TESTS:
Three concentrations ( 1, 2 and 3%) were tested for intradermal injection. After three days, concentrations were confirmed where necrosis and ulceration in the skin or systemic symptoms were not observed. 3% was the maximum dose that was injectable intradermally.
The test substance was applied dermally (25 and 40%) under occlusive conditions. After 24 h, concentrations were confirmed where necrosis and ulceration in the skin or systemic symptoms were not observed. 40 % was the maximum dose that was applicable homogeneously.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 (intradermal, dermal (10% SDS and 25% test substance)
- Exposure period: 6 days intradermal sensitisation, 24 h dermal SDS treatment, 48 h occlusive dermal induction
- Test groups: with Freunds complete adjuvant
- Control group: untreated
- Site: shaved 4 x 6 cm dorsal area
B. CHALLENGE EXPOSURE
- No. of exposures: 1 (dermal)
- Day(s) of challenge: two weeks after completion of induction phase
- Exposure period: 24 h
- Test groups: all animals
- Control group: all animals
- Site: shaved 5 x 5 cm area of right flank
- Concentrations: 40%
- Evaluation (hr after challenge): 24 h
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 40%
- No. with + reactions:
- 0
- Total no. in group:
- 15
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 40%. No with. + reactions: 0.0. Total no. in groups: 15.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 40%
- 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: 40%. 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
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