Registration Dossier
Registration Dossier
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EC number: 915-768-0 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1980
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- abstract
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Version / remarks:
- The study was conducted prior to OECD guidance. However, the general principles are similar.
- Principles of method if other than guideline:
- Standard MT testing strategy for studies conducted according to Magnusson and Kligman.
- GLP compliance:
- no
- Remarks:
- Standard MT testing strategy for studies conducted according to Magnusson and Kligman.
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The in vivo study "Capacity of allergic sensitization determined by the maximisation test (MT) on guina pigs" was already available (performed in 1980) and reliable to evaluate the skin sensitization potential and the classification determination.
Test material
- Reference substance name:
- Ethyl 2-ethyl-6,6-dimethylcyclohex-2-ene-1-carboxylate
- EC Number:
- 261-020-5
- EC Name:
- Ethyl 2-ethyl-6,6-dimethylcyclohex-2-ene-1-carboxylate
- Cas Number:
- 57934-97-1
- Molecular formula:
- C13H22O2
- IUPAC Name:
- ethyl 2-ethyl-6,6-dimethylcyclohex-2-ene-1-carboxylate
- Reference substance name:
- Ethyl 2,3,6,6-tetramethylcyclohex-2-ene-1-carboxylate
- EC Number:
- 278-776-7
- EC Name:
- Ethyl 2,3,6,6-tetramethylcyclohex-2-ene-1-carboxylate
- Cas Number:
- 77851-07-1
- Molecular formula:
- C13H22O2
- IUPAC Name:
- ethyl 2,3,6,6-tetramethylcyclohex-2-ene-1-carboxylate
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- Test material name: Givescone
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- Standard MT testing strategy for studies conducted according to Magnusson and Kligman.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: FCA
- Concentration / amount:
- 5%
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 25%
- Day(s)/duration:
- 2 days
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 10%, 3%, 1%
- Day(s)/duration:
- 24 hours
- No. of animals per dose:
- 19 animals were used
- Details on study design:
- Standard MT testing strategy for studies conducted according to Magnusson and Kligman.
- Positive control substance(s):
- no
Study design: in vivo (LLNA)
- Vehicle:
- other: Petrolatum
- Concentration:
- 25% in petrolatum, challenge at 1%, 3%, 10%.
- No. of animals per dose:
- 19
Results and discussion
- Positive control results:
- NA
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1%, 3%, 10%
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Clinical observations:
- no effects
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1%, 3%, 10%
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Clinical observations:
- No effects
In vivo (LLNA)
Results
- Parameter:
- other:
- Remarks on result:
- not determinable
Any other information on results incl. tables
Challenge patch tests 3 and 5 weeks after the beginning of the treatment are negative.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions used in the Maximisation test, Givecsone does not sensitize Guinea pigs.
- Executive summary:
This study was performed to investigate the potential of Givescone to sensitize in a maximisation test (MT) on guina pigs.
On day 0, the animals were injected intradermally with 0.1 ml of a 5% solution of the compound, with 0.1 ml of a 5% emulsion of the compound in FCA and with 0.1 ml of FCA alone, each injection was given twice. In addition, on day 8 the compound, dissolved in petrolatum up to 25% was applied to a clippped skin area of the neck and kept under occlusive bandage for 2 days (total of 20 mg intradermally plus 250 mg epicutaneously). On day 21, an occlusive patch test with the compound in petrolatum was applied to the flank for 24 hours and the reactions were read 24 and 48 hours after removing the patch. Under the test conditions used in the Maximisation test, Givescone does not sensitize Guinea pigs.
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