Registration Dossier
Registration Dossier
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EC number: 617-834-1 | CAS number: 863329-69-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- Jul to Aug 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well reported GLP 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)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 7α-bromo-5,6β-epoxy-15β,16β-methylene-3β-pivaloyloxy-5β-androstan-17-one
- EC Number:
- 617-834-1
- Cas Number:
- 863329-69-5
- Molecular formula:
- C25H35BrO4
- IUPAC Name:
- 7α-bromo-5,6β-epoxy-15β,16β-methylene-3β-pivaloyloxy-5β-androstan-17-one
- Details on test material:
- - Name of test material (as cited in study report): ZK 137314
- Batch No.: 21608209
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:
- other: liquid parrafin
- Concentration / amount:
- Intradermal induction: 1.25 %
Topical induction: 25%
Challenge: 25%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: liquid parrafin
- Concentration / amount:
- Intradermal induction: 1.25 %
Topical induction: 25%
Challenge: 25%
- No. of animals per dose:
- control group: 10 (5/sex)
test substance group: 10 (5/sex)
pre-test (local tolerance test): 9
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Challenge 25%
- No. with + reactions:
- 1
- 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: 1.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- 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.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Challenge 25%
- No. with + reactions:
- 1
- 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: 1.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- 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 (slight to moderate swelling and/or small necroses) in the area of epidermal induction (neck). 24 h after challenge with 25% ZK 137314 1 out of 10 animals showed slight reddening at the administration site, which was no longer seen 48 h after exposure. At this time point, a further animal of the test group showed slight reddening.
Applicant's summary and conclusion
- Executive summary:
To determine the skin-sensitizing properties of ZK 137314 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: 1.25%
epidermal induction: 25%
challenge: 25%
24 h after challenge 1 out of 10 animals showed slight reddening at the administration site, which was no longer seen 48 h after exposure. At this time point, a further animal of the test group showed slight reddening. Due to the low incidence of the local findings and due to the slight grade of the findings, these were regarded as incidental findings and not as indicative of any contact-sensitizing potential of ZK 137314. Thus Bromepoxid did not show any skin-sensitization potential in the guinea pig.
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