Registration Dossier
Registration Dossier
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EC number: 617-351-6 | CAS number: 82544-13-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992-07-17
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was performed in 1998. The Test guideline (TG) for the determination of skin sensitization in the mouse, the LLNA (TG 429) was adopted in 2002.
Test material
- Reference substance name:
- 5,6 beta-Epoxy-7 beta-hydroxy-15 beta,16 beta-methylene-3 beta-pivaloyloxy-5 beta-androstan-17-one
- EC Number:
- 617-351-6
- Cas Number:
- 82544-13-6
- Molecular formula:
- C25 H36 O5
- IUPAC Name:
- 5,6 beta-Epoxy-7 beta-hydroxy-15 beta,16 beta-methylene-3 beta-pivaloyloxy-5 beta-androstan-17-one
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- paraffin oil
- Concentration / amount:
- Intradermal induction: 5 %
Topical induction: 25%
Challenge: 25%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- Intradermal induction: 5 %
Topical induction: 25%
Challenge: 25%
- No. of animals per dose:
- control group: 10
test substance group: 10
pre-test (local tolerance test): 9
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Challenge 25%
- 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: Challenge 25%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- 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: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Challenge 25%
- 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: Challenge 25%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- 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: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Any other information on results incl. tables
No mortalities occurred. From day 8 onwards all animals showed clear-cut skin irritations (reddening, swelling and/orn necroses) in the area of epidermal induction (neck). None of the animals showed local reactions after epidermal administration of 25% ZK 90346 for challenging.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the condition of the maximization test and with respect to the evaluation criteria Methylenepoxidpivalat exhibited no skin-sensitization potential.
- Executive summary:
To determine the skin-sensitizing properties of ZK 90346 the guinea pig maximization test was performed on male and female guinea pigs according to OECD guideline 406. The study was conducted with the following test substance concentrations:
intradermal induction: 5%
epidermal induction: 25%
challenge: 25%
Under the condition of the maximization test and with respect to the evaluation criteria Methylenepoxidpivalat exhibited no skin-sensitization potential.
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