Registration Dossier
Registration Dossier
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EC number: 609-765-0 | CAS number: 39987-85-4
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:
- other information
- Study period:
- Feb to Mar 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- - modified maximization test: an epidermal induction on the scarified skin is performed instead of intracutaneous induction
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 39987-86-5
- EC Number:
- 609-766-6
- Cas Number:
- 39987-86-5
- IUPAC Name:
- 39987-86-5
- Reference substance name:
- M-DOC
- IUPAC Name:
- M-DOC
- Reference substance name:
- 21-Hydroxy-16 alpha-methyl-4-pregnene-3,20-dione
- IUPAC Name:
- 21-Hydroxy-16 alpha-methyl-4-pregnene-3,20-dione
Constituent 1
Constituent 2
Constituent 3
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-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: see "Any other information on materials and methods"
topical induction (days 1, 2 and 3): 25 %
topical challenge (days 21 and 28): 25 %
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: liquid parrafin
- Concentration / amount:
- intradermal induction: see "Any other information on materials and methods"
topical induction (days 1, 2 and 3): 25 %
topical challenge (days 21 and 28): 25 %
- No. of animals per dose:
- control group: 10 (5/sex)
test substance group: 10 (5/sex)
pre-test (local tolerance test, rechallenge control group): 6 (3/sex)
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:
- 9
- Clinical observations:
- very slight to slight reddenings
- 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: 9.0. Clinical observations: very slight to slight reddenings.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- challenge 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 9
- 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: 9.0. Clinical observations: none.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- challenge 25 %
- No. with + reactions:
- 2
- Total no. in group:
- 9
- Clinical observations:
- very slight to slight reddenings
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: challenge 25 %. No with. + reactions: 2.0. Total no. in groups: 9.0. Clinical observations: very slight to slight reddenings.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- challenge 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- none
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: challenge 25 %. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- very slight to slight reddenings
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. No with. + reactions: 3.0. Total no. in groups: 10.0. Clinical observations: very slight to slight reddenings.
- 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.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 3
- Total no. in group:
- 6
- Clinical observations:
- very slight to slight reddenings
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. No with. + reactions: 3.0. Total no. in groups: 6.0. Clinical observations: very slight to slight reddenings.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- none
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 6.0. Clinical observations: none.
Any other information on results incl. tables
One female animal of the test group was found dead on day 2. The animal had possibly died from stress (due to the bandage) during the first induction.
After the first challenge and the rechallenge 1 or 2 of a total of 9 animals showed very slight to slight reddenings on the treated area only 24 hours after the end of challenge. Very slight to slight reddenings each occurred in 3 control animals (first challenge 3/10, rechallenge 3/6).
Applicant's summary and conclusion
- Executive summary:
In a modified guinea pig maximization test (GPMT) according to OECD TG 406 no skin sensitizing potential of the test substance could be observed based on the results after the first challenge and the rechallenge with 25 % ZK 9340.
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