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Registration Dossier
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EC number: 226-133-6 | CAS number: 5292-43-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From June 05th to 19th, 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 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted on 17th,07,1992
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
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
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd, Sandbach UK
- Age at study initiation: from 12 to 16 weeks old.
- Weight at study initiation: from 2.0 to 3.5 kg.
- Housing: individually in suspended metal cages.
- Diet:STANRAB SQC rabbit 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
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 ml
- pH: the pH of the undiluted test material was determined prior to commencement of the study and was found to be 7.3. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours after patches removal.
Additional observation made on day 7 to assess the reversibility. - Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm cotton gauze treated with test material.
- Type of wrap if used: elasticated corset.
REMOVAL OF TEST SUBSTANCE
- Washing: swabbing with cotton wool soaked with 74 % methylated spirits.
- Time after start of exposure: 4 hours
SCORING SYSTEM
Erythema and eschar formation
No erythema...................................................0
Very slight erythema (barely perceptible)......1
Well-defined erythema....................................2
Moderate to severe erythema.........................3
Severe erythema to slight eschar formation...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
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- 3.33
- Reversibility:
- not reversible
- Irritant / corrosive response data:
- Severe erythema and severe oedema were noted on all animals 1 and 24 hours after patch removal, with severe erythema and moderate oedema at 48 and 72 hours. Well-defined erythema extended approximately 5 cm beyond the treatment sites of all animals one hour after patch removal and at 24, 48 and 72 hours observation.
Dermal haemorrhage, resempbling a purble/black colored bruise, was noted at all treated skin sites one hour after removal and at the 24, 48 and 72 hours.
A hardened dark brown colored scab, undulating in appearance and preventing evaluation of erythema and oedema, was noted on all animals at the 7 day observation.
The reactions noted at all treated skin sites were indicative of dermal corrosion. All animals were killed for humane reasons immediately after the 7-day observation in accordanco with current UK Home Office guideline.
Any other information on results incl. tables
Calculation for CLP classification
| Observation time | Rabbit no. 1 | Rabbit no. 2 | Rabbit no. 3 | |||
| Erythema | Oedema | Erythema | Oedema | Erythema | Oedema | |
| 24 h | 4 | 4 | 4 | 4 | 4 | 4 |
| 48 h | 4 | 3 | 4 | 3 | 4 | 3 |
| 72 h | 4 | 3 | 4 | 3 | 4 | 3 |
| Mean value | 4 | 3.33 | 4 | 3.33 | 4 | 3.33 |
Individual skin reactions
| Rabbit no. | Time after exposure | |||||||||
| 1 hour | 24 hours | 48 hours | 72 hours | 7 days | ||||||
| Erythema/eschar | Oedema | Erythema/eschar | Oedema | Erythema/eschar | Oedema | Erythema/eschar | Oedema | Erythema/eschar | Oedema | |
| 1 | 4 HdR | 4 | 4 HdRLe | 4 Oe | 4 HdRLeLF | 3 Oe | 4 HdRLeLF | 3 | ? eStSwK | ? od |
| 2 | 4 HdR | 4 | 4 HdRLe | 4 Oe | 4 HdRLeLF | 3 Oe | 4 HdRLeLF | 3 | ? eStSwK | ? od |
| 3 | 4 HdR | 4 | 4 HdRLe | 4 Oe | 4 HdRLeLF | 3 Oe | 4 HdRLeLF | 3 | ? eStSwK | ? od |
Hd = dermal haemorrhage resembling a purple/black colored bruise
R = well-defined erythema
Oe = severe oedema
Le = loss of skin elasticity
Lf = loss of skin flexibility
St = hardened dark brown/black colored scab
Sw ? scab ondulating
?e = adverse reactions prevented evaluation of erythema
?od = adverse reactions prevented evaluation of oedema
K = animal humanely killed immediately after observation
Applicant's summary and conclusion
- Interpretation of results:
- other: Skin Corr. 1B (H314), according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- Skin corrosive, Subcategory 1B.
- Executive summary:
The test was performed according to OECD 404 (1992). Three New Zeland White rabbit were treated with a single 4 -hours semi-occluded application of test material. Reactions were scored at 1, 24, 48 and 72 hours after patches removal. Additional observation made on day 7 to assess the reversibility.
Severe erythema and severe oedema were noted on all treated animals after 4 hours of patch removal.
Conclusion
The substance is classified as Skin Corr. 1B.
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