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Toxicological information

Skin sensitisation

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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:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
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
Name:
Unnamed
Type:
Constituent
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

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 group
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