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EC number: 246-625-4 | CAS number: 25111-05-1
Toxicological information
Skin sensitisation
Currently viewing:
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 25 Jan - 04 March 2002
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP-guideline study with acceptable restrictions (analytical purity not reported; use of positive control was not specified; 3 animals were above the weight limit specifed in the Standard Test Method)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted on 1992
- Deviations:
- yes
- Remarks:
- analytical purity not reported; use of positive control was not specified; 3 animals were above the weight limit specifed in the Standard Test Method
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- adopted in 1996
- Deviations:
- yes
- Remarks:
- analytical purity not reported; use of positive control was not specified; 3 animals were above the weight limit specifed in the Standard Test Method
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Department of health of the government of the United Kingdom, UK
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 403507-18-6
- EC Number:
- 609-825-6
- Cas Number:
- 403507-18-6
- IUPAC Name:
- 403507-18-6
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Physical state: dark amber slightly viscous liquid
- Analytical purity: no data
- Storage condition of test material: room temperature in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: David Hall Limited, Burton-on-Trent, Staffordshire, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 371-480 g
- Housing: individual or in pairs in solid-floor polypropylene cages with woodflakes.
- Diet: certified Guinea Pig Diet, PMI Nutrition International, Nottingham, UK; ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): at least 15 per hour
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: arichis oil BP
- Concentration / amount:
- Induction: 5 (intradermal) and 100% (topical)
Challenge: 100 and 75%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: arichis oil BP
- Concentration / amount:
- Induction: 5 (intradermal) and 100% (topical)
Challenge: 100 and 75%
- No. of animals per dose:
- 5 (controls), 10 (in test groups)
- Details on study design:
- RANGE FINDING TESTS:
-Selection of concentration for intradermal induction:
Intradermal injections (0.1 mL/injection site) were performed on the clipped shoulder of two guinea pigs, at concentrations of 1% and 5% v/v in arachis oil BP. The degree of erythema at the injection sites was assessed approximately 24, 48, 72 hours and 7 days after injection. Any proof of toxicity was recorded as well.
A concentration of 5% was selected as the highest concentration that caused mild to moderate skin irritation, and that was well tolerated systematically.
-Selection of concentration for topical induction:
The test material was applied on clipped flanks of two guinea pigs under occlusive dressing at the following concentrations: 100, 75, 50 and 25% v/v in arichis oil BP. The erythema and edema scores were determined approximately 1, 24, and 48 hours after dressing removal. 100% was selected for the topical induction of the main study as the highest concentration producing only mild to moderate dermal irritation.
-Selection of concentration for topical induction:
The test material was applied to the clipped flanks of two guinea pigs under occlusive dressings for an exposure period of 24 h at the following concentrations: 75%, 50% and 25% v/v in arachis oil BP) Erythema and edema scores were determined at approximately 1, 24, and 48 h after dressing removal.
The highest non-irritant concentration of the test material (100%) and one lower concentration were selected for the topical challenge stage of the main study.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture FCA/water
Injection 2: test substance in arachis oil BP
Injection 3: test substance in a 1:1 mixture FCA/water
Epicutaneos: undiluted test substance
- Control group:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture FCA/water
Injection 2: arachis oil BP
Injection 3: arachis oil BP at 50% in a 1:1 mixture FCA/water
Epicutaneos: arachis oil BP
- Site: shoulder region (intradermal + epicutaneous)
- Frequency of applications: Day 0: intradermal, Day 7: epicutaneous induction
- Duration: Days 0-7
- Concentrations: intradermal 5%, epicutaneous 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 21
- Exposure period: 24 h
- Test groups: test substance
- Control group: test substance
- Site: right flank (100% test substance), left flank (75% test substance)
- Concentrations: 100% and 75%
- Evaluation (hr after challenge): 48 and 72 h - Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 100
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 100. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 100
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 72.0. Group: test group. Dose level: 100. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 75
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 75. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 75. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 75
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 75. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 75
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 75. No with. + reactions: 0.0. Total no. in groups: 10.0.
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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