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EC number: 237-725-9 | CAS number: 13945-76-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06 Jan - 07 May 2002
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Analytical purity was not specified, lack of methodological details.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted in 1992
- Deviations:
- yes
- Remarks:
- analytical purity of test substance not specified, lack of methodological details
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- analytical purity of test substance not specified, lack of methodological details
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Department of Health of the Government of the United Kingdom
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was conducted in Jan 2002, prior to adoption of OECD guideline 429 (LLNA) in April 2002.
Test material
- Reference substance name:
- -
- EC Number:
- 441-620-5
- EC Name:
- -
- Cas Number:
- 163961-32-8
- Molecular formula:
- C20H40O2 (C16iso) C22H44O2 (C18iso) C22H42O2 (C18:1iso)
- IUPAC Name:
- Fatty acids, C16-18 and C18-unsatd., branched and linear, butyl esters
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, UK
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 349 g
- Housing: singly or in pairs in solid floor propylene cages
- Diet: ad libitum, certified guinea pig diet (Code 5026, PMI Nutrition International, UK)
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- arachis oil
- Remarks:
- BP
- Concentration / amount:
- 1% v/v, 0.1 mL per injection site
- Day(s)/duration:
- on Day 0
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%, filter patch 40 mm x 20 mm loaded with test material
- Day(s)/duration:
- on Day 7
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- arachis oil
- Concentration / amount:
- 75% v/v and 50% v/v
- Day(s)/duration:
- on Day 21for 24h of exposure
- Adequacy of challenge:
- other: 75% was used as max. non-irritant concentration, 50% was used to ensure max. non-irritant concentration
- No. of animals per dose:
- 10
- Details on study design:
- RANGE FINDING TESTS: Yes, treatment concentrations of the main study are based on these results.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: Intradermal induction and epidermal induction
- Test groups: 10 animals, TS
- Control group: animals treated with vehicle
- Concentrations: 1% dilution of the test substance in arachis oil was used for intradermal induction and 100% used for epidermal induction
Intradermal injections (0.1 mL / injection site) were made on the clipped shoulder, using concentrations of 1% in arachis oil BP with and without Freund's Complete Adjuvant. The degree of erythema at the injection sites was assessed approximately 24,48,72 hours and 7 days after injection.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 21
- Exposure period: 24 h
- Site: right flank
- Test groups: 10 animals, TS
- Control group: 5, treated analogous to the test groups
- Concentrations: 50% and 75% solution in arachis oil
- Evaluation (hr after challenge dressing removal): 24 and 48 h
The challenge sites were swabbed with cotton wool soaked in diethyl ether to remove residual material. The position of the treatment sites was identified by using a black indelible marker-pen.
The study was performed between 18 Jan - 21 February 2002. - Positive control substance(s):
- yes
- Remarks:
- alpha-hexylcinnamaldehyde, 2-Mercaptobenzothiazole
Results and discussion
- Positive control results:
- Reliability checks had been performed 2 times a year with 10 test and 5 control animals using alpha-hexylcinnamaldehyde and 2-Mercaptobenzothiazole as positive control substances confirming the sensititvity of the used animal strain.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- none
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Reading:
- other: performed 25 Jan - 25 Feb 2001 with alpha-Hexyl cinnamaldehyde
- Group:
- positive control
- Dose level:
- 100% and 75% in arachis oil BP
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Reading:
- other: performed 26 Sep - 29 Oct 2001 with alpha-Hexyl cinnamaldehyde
- Group:
- positive control
- Dose level:
- 100% and 75% in arachis oil BP
- No. with + reactions:
- 2
- Total no. in group:
- 10
Any other information on results incl. tables
Challenge readings
Group |
Animal Number |
Skin Reactions (Hours after Removal of Dressings) |
|||||||
24 h |
48 h |
||||||||
50% |
75% |
50% |
75% |
||||||
Er |
Ed |
Er |
Ed |
Er |
Ed |
Er |
Ed |
||
Test Group |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
6 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
8 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
9 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
10 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
|
Control Group |
11 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
12 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
13 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
14 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
15 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Ed: Edema
Er: Erythema
Positive controlls were in the range of the historical controls.
No deaths occured. No significant differences in the gain of body weight was observed between treatment and control group.
A transient challenge reaction (discrete erythema) was observed in one animal of the test group at 24 h observation with desquamation at the 48 h observation. The erythema was not apparent at the 48 h observation and therefore not attributed to contact sensitization
Applicant's summary and conclusion
- Interpretation of results:
- other: No indication for skin sensitising potential was found.
- Conclusions:
- CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
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