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EC number: 226-133-6 | CAS number: 5292-43-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From June 22nd to July 28th, 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted 17th,07,1992
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An appropriate guinea pig maximisation test was already avaiable, which would not justify conducting an additional LLNA due to animal welfare.
Test material
- Reference substance name:
- tert-butyl bromoacetate
- EC Number:
- 226-133-6
- EC Name:
- tert-butyl bromoacetate
- Cas Number:
- 5292-43-3
- Molecular formula:
- C6H11BrO2
- IUPAC Name:
- tert-butyl bromoacetate
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, Staffordshire UK
- Age at study initiation: from 8 to 12 weeks
- Weight at study initiation: from 300 to 450 g
- Housing: individually in solid-floor polypropilene cages.
- Diet: Guinea Pig FD1 Diet
- Water: free access to tap water.
- Acclimation period: at least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature: 17 - 23 °C
- Humidity: 30 - 70 %
- Air changes: at least 15 ACH
- Photoperiod: 12 hours dark
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- arachis oil
- Concentration / amount:
- 0.1 % v/v test item
- Route:
- epicutaneous, occlusive
- Vehicle:
- arachis oil
- Concentration / amount:
- 1 % v/v test item
- Day(s)/duration:
- 48 hours
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- arachis oil
- Concentration / amount:
- 0.5 and 1 % v/v test item
- Day(s)/duration:
- 24 hours
- No. of animals per dose:
- Main study
- 15 animals (10 treated, 5 control)
Pre-test
- 4 animals for intradermal injections concentrations
- 6 animals for topical induction
- 2 animals for topical challenge - Details on study design:
- RANGE FINDING TESTS
A. Concentration for intradermal induction
4 guinea pigs were treated with 0.1 ml/injection site using concentrations of 0.1, 0.5, 1 and 5 % v/v test item in arachis oil.
The highest concentration that caused only mild to moderate skin irritation was selected.
B. Concentration for topical application
2 guinea pigs were treated with undiluted test material and three preparations of the test material (75, 50, 25 % v/v test item in arachis oil) plus FCA. Animals were found dead 48 hours after.
2 additional guinea pigs were treated two preparations of the test material (100 and 25 % or 75 and 50 % v/v test item in arachis oil). Systemic toxicity effects were noted, therefore 2 additional animals were treated with two lower test item concentration (10 and 1 % or 5 and 2 %). The highest concentration that caused only mild to moderate skin irritation was selected.
C. Concentration for topical challenge
2 guinea pigs were treated with four preparations of the test material (2, 1, 0.5 and 0.1 % v/v in arachis oil).
The highest non-irritant concentration and one lower concentration were selected for challenge stage.
MAIN STUDY
A1. INDUCTION EXPOSURE - Intradermal injections
- Site: shoulder region; square filter paper patch 2x2 cm.
- Injections: 3 pairs at 0.1 ml/site
Test article: 0.1 % v/v test item in arachis oil
FCA: 1:1 with distilled water.
Test article: 0.1 % v/v test item in 1:1 FCA
- Evaluation: 24 and 48 hours after injection.
A2, INDUCTION EXPOSURE - Epidermal applications
- Site: same scapular area, 4x6 cm clipped and shaved free of air.
- Concentration: 1 % v/v in arachis oil
- Bandage: occlusive dressing, help by a strip of surgical adhesive tape with overlapping aluminium foil.
- Duration: 48 hours
- Evaluation: reaction sites were checked 1 and 24 hours following removal.
B. CHALLENGE EXPOSURE
- Exposure period: 24 hours.
- Area: square filter paper patch 2x2 cm.
- Test group: 10 males.
- Control group: 5 males.
- Site: shorn right flank.
- Bandage: overlapping lenght of aluminium foil secured with a strip of elastic adhesive bandage.
OTHER - INTERPRETATION OF RESULTS
Skin reactions noted were attributed to skin sensitisation providing that reactions of equal severity are not seen at the corresponding challenge site of the control group animals.
Erythema
No erythema...................................................0
Very slight erythema (barely perceptible)......1
Discrete of patchy erythema..........................2
Moderate and confluent erythema..................3
Intense erythema and swelling.......................4
Oedema formation
No oedema..............................................................................................................0
Very slight oedema (barely perceptible).................................................................1
Slight oedema (edges well-defined)........................................................................2
Moderate oedema (raised ca. 1 mm).......................................................................3
Severe oedema (raised more than 1 mm; extending beyond area of exposure)....4
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 %
- No. with + reactions:
- 9
- Total no. in group:
- 9
- Clinical observations:
- 9/9 erythema; 0/9 sensitised
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1 %
- No. with + reactions:
- 9
- Total no. in group:
- 9
- Clinical observations:
- 9/9 erythema; 0/9 sensitised
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 and 1 %
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
One test group animal was humanely killed on day 21 due to large open wound. The absence of the animal was considered not to affect the purpose or integrity of the study.
Individual skin reactions at challenge
| Group | Animal no. | Skin reactions (hours after removal of dressing) | |||||||
| 24 hours | 48 hours | ||||||||
| 0.5 % | 1 % |
0.5 % |
1 % |
||||||
Er |
Oe |
Er |
Oe |
Er |
Oe |
Er |
Oe |
||
Test |
1 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
2 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
|
3 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
|
4 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
|
5 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
|
6 |
* |
* |
* |
* |
* |
* |
* |
* |
|
7 |
1 |
0 |
2 |
1 |
0 |
0 |
0 |
0 |
|
8 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
|
9 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
|
10 |
1 |
0 |
1 |
0 |
0 |
0 D |
0 |
0 D |
|
Control |
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 | |
Er = erythema
Oe = oedema
* = killed animal
D = desquamation
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified, according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- The test substance did not show sensitising effects on test animals.
- Executive summary:
The Guinea Pig Maximisation Test was performed according to OECD 406 (1992). A total of 27 animals were used, 15 for the main study (10 test and 5 control) and 12 for the primary study. The induction phase was accomplished by both intradermal and epicutaneous application. In the challenge phase, the test substance resulted in a sensitisation rate of 0 %, when tested at the maximum testable epidermal applications of 0.5 and 1 % v/v test article.
According to regulation EC 1278/2008 (CLP) the substance does not meet the criteria for classification, since the sensitisation rate is lower than 30 %.
Conclusion
Not skin sensitizing
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