Registration Dossier
Registration Dossier
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EC number: 423-860-2 | CAS number: 56309-94-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 September 1996 - 03 February 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was conducted in 1990 when the LLNA was not an established test method yet.
Test material
- Reference substance name:
- -
- EC Number:
- 423-860-2
- EC Name:
- -
- Cas Number:
- 56309-94-5
- Molecular formula:
- Hill formula: C14H22O3 CAS formula: C14H22O3
- IUPAC Name:
- 4-{1,4-dioxaspiro[4.5]decan-8-yl}cyclohexan-1-one
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Remarks:
- Crl:(HA)BR
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Kisslegg
- Females nulliparous and non-pregnant: not specified
- Microbiological status of animals, when known: not specified
- Age at study initiation: approx. 4 weeks
- Weight at study initiation: 310 - 365 g
- Housing: 2 animals/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days
- Indication of any skin lesions: not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24°C
- Humidity (%): 47 - 75%
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light
- IN-LIFE DATES: From: To: 29 October 1996 - 06 December 1996
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- paraffin oil
- Concentration / amount:
- 5 g/L
- Day(s)/duration:
- 0 / single application
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 250 g/L
- Day(s)/duration:
- 8 / 48 hours
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 250 g/L
- Day(s)/duration:
- 22 / 24 hours
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 25 g/L
- Day(s)/duration:
- 36 / 24 hours
- No. of animals per dose:
- Number of animals in test group: 20
Number of animals in negative control group: 10 - Details on study design:
- RANGE FINDING TESTS:
1. Vehicle intradermal: undiluted
2. Test item:
- intradermal: 1, 5, 10, 25 and 50 g/L
- topical 10, 50, 100 and 250 g/L
- topical with FCA: 10, 50, 100 and 250 g/L
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: intradermal injection, topical application, no washing
- Test groups: 2
- Control group: 2
- Site: back
- Frequency of applications: single application
- Duration: 48 hours
- Concentrations: 5 g/L, 250 g/L
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: day 22 and 36
- Exposure period: topical application, no washing
- Test groups: 2
- Control group: 2
- Site: right or left flank
- Concentrations: 250 g/L (1st challenge) and 25 g/L (2nd challenge)
- Evaluation (hr after challenge): 24 and 48 hours after challenge - Challenge controls:
- yes
- Positive control substance(s):
- no
- Remarks:
- no concurrent positive controls, but positive control data from parallel studies reported
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 7
- Total no. in group:
- 20
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 2.5 %
- No. with + reactions:
- 9
- Total no. in group:
- 20
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 2.5 %
- No. with + reactions:
- 10
- Total no. in group:
- 20
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 2.5%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 2.5%
- No. with + reactions:
- 3
- Total no. in group:
- 10
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 25 %
Signs of irritation during induction:
Typical signs of an irritation after injection of Freund's
Adjuvans (swelling, rednes, necrosis, scaling).
After topical application: Swelling, redness, scaling.
Evidence of sensitisation of each challenge concentration:
slight edema, erythema
Other observations:
none
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Based on the findings of this study, the test item is considered to have skin sensitising properties.
- Executive summary:
A guinea-pig maximisation test according to Magnusson and Kligman (OECD 406) was performed to identify the skin sensitising potential of the test item. 10 females in the negative control group (group 1) and 20 females in the test item group (group 2) were investigated.
Induction included intradermal injection of the test item at a concentration of 5 g/L (with and without Freund's complete adjuvant) on day 1 and topical application of the test item at a concentration of 250 g/L on day 8. Challenge I by topical application of the test item was performed with a concentration of 250 g/L. Due to questionable results after the first challenge, a second challenge (challenge II) with a lower concentration of 25 g/L was considered to be necessary two weeks later.
After challenge I positive reactions (erythema) were observed in 8 of 20 animals (40%). Challenge II revealed positive reactions in the treated areas in 10 of 20 animals (50%). The test item was considered a skin sensitiser.
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