Registration Dossier
Registration Dossier
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EC number: 241-475-6 | CAS number: 17462-58-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion, other
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline Study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- sec. Butylchloroformate
- IUPAC Name:
- sec. Butylchloroformate
- Reference substance name:
- sec-butyl chloroformate
- EC Number:
- 241-475-6
- EC Name:
- sec-butyl chloroformate
- Cas Number:
- 17462-58-7
- Molecular formula:
- C5H9ClO2
- IUPAC Name:
- butan-2-yl carbonochloridate
- Reference substance name:
- 83/282
- IUPAC Name:
- 83/282
- Details on test material:
- - Name of test material (as cited in study report): sec.-Butylchlorformiat (butyl carbonochloridic acid ester)- Physical state: clear liquid- Analytical purity: ca. 99%- Impurities (identity and concentrations): traces of phosgene, di-sec.-butylcarbonate, 2-chlorobutane, HCl- Expiration date of the lot/batch: at least march 1984- Stability under test conditions: max. 24 h- Storage condition of test material: < 5°C
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Gaukler, Offenbach, D- Weight at study initiation: 2.96 - 3.25 kg- Diet: ca. 130 g/d Ovator Solikanin 4mm, Duesseldorf, D- Water: ca. 250 ml tap water- Acclimation period: at least 8 dENVIRONMENTAL CONDITIONS- Temperature (°C): 20 - 24- Humidity (%): 30 - 70- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL- Amount(s) applied (volume or weight with unit): ca. 0.5 ml
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 8 d
- Number of animals:
- 3
- Details on study design:
- TEST SITE- Area of exposure: 2.5x2.5 cm- Type of wrap if used: porous dressing (four layers absorbend gauze + porous bandage)REMOVAL OF TEST SUBSTANCE- Washing (if done): Lutrol and Lutrol/water (1:1)SCORING SYSTEM: OECD Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24-48-72 h
- Score:
- 2.89
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 d
- Remarks on result:
- other: see freetext for further details
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24-48-72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 d
- Remarks on result:
- other: see freetext for further details
Any other information on results incl. tables
Exposition: | 4 h | |||
Animal | Reading | Erythema | Edema | Symptoms |
1 | 4 h | 2 | 2 | erythema and oedema extending beyond the area of exposure |
2 | 4 h | 2 | 2 | erythema and oedema extending beyond the area of exposure |
3 | 4 h | 2 | 2 | erythema and oedema extending beyond the area of exposure |
1 | 24 h | 2 | 4 | erythema and oedema extending beyond the area of exposure |
2 | 24 h | 3 | 4 | erythema and oedema extending beyond the area of exposure |
3 | 24 h | 3 | 3 | erythema and oedema extending beyond the area of exposure |
1 | 48 h | 3 | 3 | erythema and oedema extending beyond the area of exposure, hemorrhagic |
2 | 48 h | 3 | 3 | erythema and oedema extending beyond the area of exposure |
3 | 48 h | 3 | 2 | erythema and oedema extending beyond the area of exposure |
1 | 72 h | 3 | 2 | erythema and oedema extending beyond the area of exposure, hemorrhagic |
2 | 72 h | 3 | 2 | erythema and oedema extending beyond the area of exposure |
3 | 72 h | 3 | 1 | erythema and oedema extending beyond the area of exposure |
1 | 8 d | 3 | 2 | erythema and oedema extending beyond the area of exposure, hemorrhagic, superficial scurf |
2 | 8 d | 2 | 1 | erythema, oedema and scaling extending beyond the area of exposure |
3 | 8 d | 3 | 1 | erythema, oedema and scaling extending beyond the area of exposure, hemorrhagic |
mean | 24 - 72 h | 2.89 | 2.67 |
|
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information
- Executive summary:
The study is conducted according to the OECD Guideline 404 without GLP requirements and is reliable without any restriction. 3 White Vienna rabbits were treated for 4 hours using semiocclusive conditions. An application site of 2.5 X 2.5 cm was covered with the test substance.
The test substance induced servere erythema and edema which are persistant at least 8 days. Erythema and edema were reported to extend beyond the area of exposure. Taken together with the result of the dermal toxicity study (Caustic effects like crust, ulcer formation were observed), in the absence of necrosis formation, sec butylchloroformate has to be regarded as irritant.
Conclusion
sec.-Butylchloroformate has to be regarded as irritant
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