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EC number: 947-381-8 | CAS number: -
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:
- November 20, 2016 - February 14, 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
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 (incl. QA statement)
- Remarks:
- FREY-TOX GmbH, Osteroda 38, 04916 Herzberg/Elster
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The guinea pig test method described in OECD TG 406 provide suitable information for hazard identification.
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- liquid
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: CA AQ02372
- expiry date: 17 June 2018
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS GmbH
- Microbiological status of animals, when known: SPF
- Weight at study initiation: 328-360 g
- Housing: macrolone cages, two or three animals per cage
- Diet: ad libitum, pelleted diet "Altromin 3123"
- Water: ad libitum, domestic quality drinking water being enriched with vitamin C and acidified with hydrochloric acid to pH 2.5
- Acclimation period: 5 days
- Indication of any skin lesions: no
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- 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:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 2.5% (w/w) test item/dose volume 0.1 mL
- Day(s)/duration:
- Day 0
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- test group with 100% test item
- Day(s)/duration:
- Day 7/48 h
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100% test item
- Day(s)/duration:
- Day 21/24 hours
- No. of animals per dose:
- control group: 5
test group: 10 - Details on study design:
- RANGE FINDING TESTS:
A pre-test was conducted to determine the concentrations for the main test. Three animals were used per concentration.
Intradermal: 2.5 and 5% tested
Dermal: 25, 50, 75 and 100% tested
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
1. Intradermal:
- Test groups: 3 pairwise arranged injections:
Injection (1): 1:1-mixture (v/v) of FCA and NaCl 0.9%
Injection (2): 2.5% (w/w) test item in the vehicle aqua dest.
Injection (3): 2.5% (w/w) test item in a 1:1-mixture (v/v) of FCA and NaCl 0.9%
- Control group: 3 pairwise arranged injections:
Injection (1): 1:1-mixture (v/v) of FCA and NaCl 0.9%
Injection (2): vehicle aqua dest.
Injection (3): 50% (w/v) preparation of the vehicle aqua dest. in a 1:1-mixture (v/v) of FCA and NaCl 0.9%
- Site: scapular region
- Frequency of applications: once
- Concentrations: 2.5% test item
2. Dermal:
- Site: scapular region
- Test groups:
Complete loading (0.5 mL) of patch with test item
- Control group:
Complete loading (0.5 mL) of patch with vehicle
- Exposure time: 48 hours
- Concentrations: 100% test item
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 21
- Exposure period: 24 hours
- Test groups: patch with 100% test item
- Control group: patch with vehicle
- Site: caudal right flank
- Evaluation (hr after challenge): after 24 and 48 hours
C. ASSESSMENT OF SKIN REACTIONS
- According to grading scale by Magnusson/Kligmann
No visible change : grade 0
Discrete or patchy erythema: grade 1
Moderate and confluent erythema: grade 2
Intense erythema and swelling: grade 3 - Positive control substance(s):
- no
- Remarks:
- but data from the last positive control study with the reference material alpha-Hexylcinnamaldehyde, technical grade, 85% conducted from January to February 2017 were provided.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- skin reactions of grade 2 (moderate and confluent erythema) in 3 animals and skin reactions grade 1 (discrete or patchy erythema) in 5 animals
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no visible changes
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- Skin reactions of grade 2 in 3 animals and skin reactions of grade 1 in 3 animals
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no visible changes
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
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