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EC number: 250-882-8 | CAS number: 31981-44-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 4.12.1978 - 19.01.1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
- Principles of method if other than guideline:
- - Principle of test: Investigation on sensitizing potential of the test substance. During an induction phase the test substance as well as a positive and a negative control were intracutaneously applied for 10 times within 3 weeks. Freund's adjuvans was mixed to the test solutions in week 2 and 3. 13 days after the last induction dose, a single challenge dose was applied intradermally. A second challenge dose was applied epidermally 12 days thereafter (maximum subirritant dose). Animals were investigated for positive reactions.
- Parameters analysed / observed: skin thickness and the two largest diameter of reddend skin parts before treatment and 24 hours after treatment were determined during week one of induction phase and at the 1. challenge dose; a reaction volume [µl] was calculated based on thickness and diameter; values of week 1 (induction phase; local tolerance) were compared to value after 1. challenge; following the 2. challenge dose the reddening of the skin was taken as an allergic reaction. - GLP compliance:
- not specified
- Type of study:
- Maurer optimisation test
- Justification for non-LLNA method:
- the guinea pig optimisation test was an adequate in vivo skin sensitisation test at the time of performance in 1979
Test material
- Reference substance name:
- Gestonorone caproate
- EC Number:
- 215-010-2
- EC Name:
- Gestonorone caproate
- Cas Number:
- 1253-28-7
- Molecular formula:
- C26H38O4
- IUPAC Name:
- 17-acetyl-3-oxoestr-4-en-17-yl hexanoate
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Züchter Hagemann
- Weight at study initiation: 302 - 482 g
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 - 22.5
- Humidity (%): 35 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: Benzyl benzoate, castor oil
- Concentration / amount:
- 0.1 mL (10 mg gestonorone caproate, 60.94 mg benzyl benzoate, 35 mg castor oil)
- Day(s)/duration:
- Day 1, 3, 5
- Adequacy of induction:
- not specified
- Route:
- intradermal
- Vehicle:
- other: benzyl benzoate, castor oil
- Concentration / amount:
- 2 mL (200 mg gestonorone caproate, 1218.8 mg benzyl benzoate, 700 mg castor oil) + 2 mL Freund's adjuvant
- Day(s)/duration:
- Day 8, 10, 12, 15, 17, 19
- Adequacy of induction:
- not specified
Challengeopen allclose all
- No.:
- #1
- Route:
- intradermal
- Vehicle:
- other: benzyl benzoate, castor oil
- Concentration / amount:
- 0.1 mL (10 mg gestonorone caproate, 60.94 mg benzyl benzoate, 35 mg castor oil)
- Day(s)/duration:
- 13 days after last induction dose (day 32)
- Adequacy of challenge:
- not specified
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: benzyl benzoate, castor oil
- Concentration / amount:
- 0.1 mL (10 mg gestonorone caproate, 60.94 mg benzyl benzoate, 35 mg castor oil)
- Day(s)/duration:
- day 44
- Adequacy of challenge:
- other: local tolerable
- No. of animals per dose:
- 20 (10 males/10 females)
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 9
- Exposure period: 3 weeks
- Test groups: Depostat I (0.1 mL [10 mg gestonorone caproate, 60.94 mg benzyl benzoate, 35 mg castor oil]), Depostat II (same formulation, but artificially aged; increase in peroxid value from 1.4 to 8.2)
- Control group: Negative control: 0.9% (w/v) NaCl (day 1, 3, 5); 2 mL 0.9% (w/v) NaCl + 2 mL Freund's adjuvant (day 8, 10, 12, 15, 17, 19)
Positive control: 0.1% (w/v) DNCB
- Site: back and lateral thoracic wall
- Frequency of applications: 2-3 days
- Concentrations: 10 % (w/v)
B. CHALLENGE EXPOSURE
Challenge #1
- No. of exposures: 1
- Day(s) of challenge: day 32
- Test groups: Depostat I (0.1 mL [10 mg gestonorone caproate, 60.94 mg benzyl benzoate, 35 mg castor oil]), Depostat II (same formulation, but artificially aged; increase in peroxid value from 1.4 to 8.2)
- Control group: Negative control: 0.9% (w/v) NaCl
Positive control: 0.1% (w/v) DNCB
- Site: back and lateral thoracic wall
- Concentrations: 10 % (w/v)
- Evaluation (hr after challenge): 24
Challenge #2
- No. of exposures: 1
- Day(s) of challenge: day 44
- Test groups: Depostat I (0.1 mL [10 mg gestonorone caproate, 60.94 mg benzyl benzoate, 35 mg castor oil]), Depostat II (same formulation, but artificially aged; increase in peroxid value from 1.4 to 8.2)
- Control group: Negative control: 0.9% (w/v) NaCl
Positive control: 25% (w/v) DNCB
- Site: occlusive tape (2x2 cm)
- Duration: 24 hours
- Concentrations: 10 % (w/v)
- Evaluation (hr after challenge): 24 after removal of occlusive tape
OTHER:
2 treatment groups: Depostat I, Depostat II
negative control
positive control
deviation from induction protocol: Depostat II - 2.5 ml Depostat II + 2.5 ml Freund's adjuvant were applied at day 8,10, 12, 15, 17, 19 - Positive control substance(s):
- yes
- Remarks:
- 2,4-Dinitrochlorobenzene (DNCB)
Results and discussion
- Positive control results:
- sensitizing
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.9% NaCl
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- not specified
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.9% NaCl
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- not specified
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1% DNCB
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- not specified
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 25% DNCB
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- not specified
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10% (Depostat I)
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Clinical observations:
- not specified
- Remarks on result:
- other: local intolerability
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10% (Depostat I)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- not specified
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: Depostat II (artificially aged)
- Dose level:
- 10%
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Clinical observations:
- not specified
- Remarks on result:
- other: local intolerability
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- other: Depostat II (artificially aged)
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- not specified
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
The observed positive reactions after the first challenge in the test item group Depostat I (5 of 20 animals) and in the additional artificially aged test item group Depostat II (3 of 20 animals) were not regarded as a sensitising effect because in both groups local intolerances were observed following intracutaneous treatment. The differences of the reaction volumes are slight compared to the ones during induction phase. Further, a sensitising effect could not be observed following a second challenge dose.
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitising
- Executive summary:
The test item gestonorone caproate (formulated as 0.1 ml Depostat - 10 mg gestonorone caproate, 60.94 mg benzyl benzoate, 35 mg castor oil) did not show sensitising potential in an in vivo guinea pig optimisation test. The validity of the test procedure was confirmed by positive and negative controls.
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