Registration Dossier
Registration Dossier
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EC number: 482-400-9 | CAS number: 138776-88-2
Toxicological information
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 8 Oct 2012 - 25 Feb 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study conducted according to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- 2003
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
Test material
- Details on test material:
- - Name of test material (as cited in study report): L4-Ligand
- Physical state: solid, white powder
- Analytical purity: > 98% (HPLC-Fingerprint; Analytical Report 12L00037)
- Lot/batch No.: 0005473663
- Stability under test conditions: stability expiration date was given as 1st August 2013
- Storage condition of test material: at ambient temperature, under an atmosphere of Argon (instead of N2; in agreement with sponsor), protected against humidity
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, Kißlegg, Germany
- Weight at study initiation: 296 - 370 g
- Housing: 2 to 3 per cage, in Makrolon cages with a floor area of 2280 cm2; Hay bricks were added as cage enrichment
- Diet: pelleted diet "Altromin 3123", ad libitum
- Water: vitamin C enriched tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- olive oil
- Concentration / amount:
- Induction: 60%
Challenge: 50%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- olive oil
- Concentration / amount:
- Induction: 60%
Challenge: 50%
- No. of animals per dose:
- Control group: 10
Test group: 20 - Details on study design:
- RANGE FINDING TEST
In order to select suitable concentrations of test item in vehicle for the main study, a preliminary patch test was done with 2 animals. Skin reaction was assessed according to the Magnusson/Kligman grading scale.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 (day 0, day 7 and day 14)
- Exposure period: 6 hours
- Test group: treated with 0.5 mL of test item in vehicle
- Control group: vehicle only
- Site: 4 x 6 cm skin area on the left flank, clipped free of hair
- Frequency of applications: at 7 day-intervals
- Duration: day 0 to day 14
- Concentrations: 60% test item in vehicle
B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge: challenge was done after 4 weeks following the first induction
- Exposure period: 6 hours
- Test groups: treated with 0.5 mL of test item in vehicle
- Control group: treated with 0.5 mL of test item in vehicle
- Site: 4 x 6 cm skin area on the right, clipped free of hair
- Concentrations: 50%
- Evaluation (hr after challenge): 24 and 48 h
READING
Skin reaction was assessed according to the Magnusson/Kligman grading scale.
FURTHER EXAMINATIONS
The animals were observed for clinical signs and reactions to treatment. They were weighed at day 0 and at the end of of the study period, i.e. on day 33. - Positive control substance(s):
- yes
- Remarks:
- positive control test with the reference material alpha-hexylcinnamaldehyde (purity 85%) was performed from Sept to Oct 2012. 13/20 treated animals showed positive reactions, corresponding to 65%.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 60% test item in vehicle for induction, 50% test item in vehicle for challenge
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 60% test item in vehicle for induction, 50% test item in vehicle for challenge. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 60% test item in vehicle for induction, 50% test item in vehicle for challenge
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- 2/20 animals showed slight erythema
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 60% test item in vehicle for induction, 50% test item in vehicle for challenge. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: 2/20 animals showed slight erythema.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50% test item in vehicle for challenge
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50% test item in vehicle for challenge. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50% test item in vehicle for challenge
- 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. Dose level: 50% test item in vehicle for challenge. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Any other information on results incl. tables
The animals showed no clinical symptoms, and body weight gain was as expected for both, the test and the control group.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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