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Registration Dossier
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EC number: 235-970-6 | CAS number: 13074-65-2
Toxicological information
Skin sensitisation
Currently viewing:
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982-03-18 - 1982-04-29
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study similar to guideline. Limited substance information (e.g. purity).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- According to the method of Magnusson and Kligman, but predating adoption by OECD as part of TG406
- Deviations:
- no
- GLP compliance:
- not specified
- Remarks:
- The study pre-dates the introduction of GLP in the United Kingdom.
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 2-n-hexyl cyclopentanone
- IUPAC Name:
- 2-n-hexyl cyclopentanone
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): 2-n-hexyl cyclopentanone.
- Substance type: liquid.
- Physical state: liquid.
- Analytical purity: no data.
- Impurities (identity and concentrations): no data.
- Composition of test material, percentage of components: no data.
- Isomers composition: no data.
- Purity test date: no data.
- Lot/batch No.: (sample ref:) 12947T1.
- Expiration date of the lot/batch: no data.
- Stability under test conditions: no data.
- Storage condition of test material: no data.
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Environmental Safety Division (Unilever in-house)
- Age at study initiation: no data.
- Weight at study initiation: about 320g.
- Housing: no data.
- Diet (e.g. ad libitum): no data.
- Water (e.g. ad libitum): no data.
- Acclimation period: no data.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data.
- Humidity (%): no data.
- Air changes (per hr): no data.
- Photoperiod (hrs dark / hrs light): no data.
IN-LIFE DATES: no data.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: For injection, vehicle was physiological saline containing 0.01% sodium dodecylbenzenesulphonate. Topical induction application was neat (no vehicle), and the challenge application was conducted in acetone/PEG.
- Concentration / amount:
- Induction injection, 2%; topical induction, 100% (neat); topical challenge, 25 or 15%.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: For injection, vehicle was physiological saline containing 0.01% sodium dodecylbenzenesulphonate. Topical induction application was neat (no vehicle), and the challenge application was conducted in acetone/PEG.
- Concentration / amount:
- Induction injection, 2%; topical induction, 100% (neat); topical challenge, 25 or 15%.
- No. of animals per dose:
- 10
- Details on study design:
- RANGE FINDING TESTS: intradermal injection irritation tests were carried out to determine a suitable concentration for the induction of sensitisation. The selected concentration was 2%, in saline containing 0.01% sodium dodecylbenzenesulphonate (DoBS). Covered patch irritation tests were carried out to determine a suitable concentration for sensitisation induction and challenge. As 75% was considered insufficiently irritant, it was decided to use neat test substance.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: two.
- Exposure period: intradermal injection, followed one week later by 48-hour covered patch application.
- Test groups: one, ten animals (6 males, 4 females).
- Control group: 4 males treated with vehicle and 4 females untreated.
- Site: intradermal injections were made to a clipped and shaved area of skin in the dorsal shoulder. Topical patches were applied to a clipped and shaved area of skin on the trunk, behind the forelimbs.
- Frequency of applications: three pairs of intradermal injections; one topical application.
- Duration: topical application for 48-hours, one week after injections.
- Concentrations: intradermal injections (2 of each): 1) 50% Freund's complete adjuvant (FCA) in saline (with 0.01% sodium dodecylbenzenesulphonate); 2) 2% test substance in vehicle; 3) 2% test substance in 50:50 mixture of vehicle and FCA. Topical application: neat (no vehicle).
B. CHALLENGE EXPOSURE
- No. of exposures: three.
- Day(s) of challenge: 13/14 (after application of the induction patch), 21/22 and 28/29.
- Exposure period: 24 hours.
- Test groups: one, ten animals (6 males, 4 females).
- Control group: 4 males treated with vehicle (challenges 1 and 2 only) and 4 females untreated (all challenge exposures).
- Site: a clipped and shaved area of the trunk.
- Concentrations: 25% (challenge 1), 15% (challenge 2 and 3) in acetone/PEG400.
- Evaluation (hr after challenge): 24 and 48 hours after removal of the patches. - Challenge controls:
- Treated controls: 4 males, treated the same way as animals administered the test substance, given a mock induction treatment in which the test substance was omitted.
Untreated controls: 4 females, previously untreated, are treated the same way as test animals at each challenge. - Positive control substance(s):
- no
Results and discussion
- Positive control results:
- No data.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: Challenge 1 (day 13/14)
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- Reaction questionable
- Remarks on result:
- other: Reading: other: Challenge 1 (day 13/14). . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: Reaction questionable.
- Reading:
- other: Challenge 1 (day 13/14)
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: Challenge 1 (day 13/14). . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other: Challenge 2 (day 21/22)
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 15%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: Challenge 2 (day 21/22). . Hours after challenge: 24.0. Group: test group. Dose level: 15%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other: Challenge 2 (day 21/22)
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 15%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: Challenge 2 (day 21/22). . Hours after challenge: 48.0. Group: test group. Dose level: 15%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other: Challenge 3 (day 28/29)
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 15%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: Challenge 3 (day 28/29). . Hours after challenge: 24.0. Group: test group. Dose level: 15%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other: Challenge 3 (day 28/29)
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 15%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: Challenge 3 (day 28/29). . Hours after challenge: 48.0. Group: test group. Dose level: 15%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
No reactions seen in any control animals (treated or untreated).
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: not specified
- Conclusions:
- Jasmatone (2-n-hexyl cyclopentanone) was found to be not sensitising in a guinea pig maximisation test, according to the method of Magnusson and Kligman.
- Executive summary:
In an in vivo guinea pig maximisation test, according to the method of Magnusson and Kligman but conducted prior to the introduction of GLP or the applicable OECD test guideline, Jasmatone (2 -n-hexyl cyclopentanone) was found to be non sensitising. One, questionable, positive reaction was seen in 1/10 test animals 24 hours after the first challenge application, but no other positive reactions were reported in test animals or vehicle or untreated controls.
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