Registration Dossier
Registration Dossier
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EC number: 212-146-4 | CAS number: 765-43-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
Test material
- Reference substance name:
- Cyclopropyl methyl ketone
- EC Number:
- 212-146-4
- EC Name:
- Cyclopropyl methyl ketone
- Cas Number:
- 765-43-5
- Molecular formula:
- C5H8O
- IUPAC Name:
- 1-cyclopropylethan-1-one
- Test material form:
- solid - liquid: suspension
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: healthy young adult animals
- Weight at study initiation: less than 500 g
- Housing: maximum 5 animals/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 08.09.1997 To: 22.10.1997
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- Preliminary test: 5, 25, 50 and 100%
Challenge: 5, 10, 25 and 50%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- Preliminary test: 5, 25, 50 and 100%
Challenge: 5, 10, 25 and 50%
- No. of animals per dose:
- Challenge treatment test group: 20 animals
Control group: 10 animals - Details on study design:
- The undiluted substance did not cause any skin irritations in a preliminary study. The 100 % test compound was used for the first induction exposure.Because of moderate systemic effects during induction I, the concentration of the test substance was reduced to 50 % in corn oil for induction II and III.
The concentration used for challenge exposure, the highest non-irritating and nontoxic dose, was identified in the 4th week of the test on the animalsof the accompanying group, same age as the animals in the main test. On this basis and based on the results from the induction period, the 50 %
formulation of the test substance in corn oil was administered for challenge treatment.. - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 30
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 30.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 54
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 54.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 30
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 30.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 54
- Group:
- test chemical
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 54.0. Group: test group. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
There were no signs of dermal irritation on the rear of the right flank of the test animals and of the control animals 30 and 54 hours after administration. Nor were cutaneous reactions found in any test or control animal with the vehicle patch on the front of the right flank.
The test and control animals showed a normal body weight gain throughout the investigation.
During induction I, the test animals showed toxic symptoms like narcotic condition and half-closed eyes for about 24 hours after treatment.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of this Buehler test, the substance did not show any evidence of sensitization.
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