Registration Dossier
Registration Dossier
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EC number: 200-858-8 | CAS number: 75-29-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented, according to accepted guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- -reliability scoring based on 2002 guideline
- Deviations:
- yes
- Remarks:
- -purity of the test article and sex of the animals were not reported
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- -purity of the test article and sex of the animals were not reported
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-chloropropane
- EC Number:
- 200-858-8
- EC Name:
- 2-chloropropane
- Cas Number:
- 75-29-6
- Molecular formula:
- C3H7Cl
- IUPAC Name:
- 2-chloropropane
- Details on test material:
- - Name of test material (as cited in study report): Isopropylchloride
- Physical state: liquid
- Analytical purity: information not reported
- Lot/batch No.: Not reported
- Expiration date of the lot/batch: Not specified by sponsor
- Stability under test conditions: Not specified by sponsor
- Storage condition of test material: refrigerated
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harald Schriever, Kaninchenfarm, D-2740 Bremervorde, Neuendamm 88
- Age at study initiation: not reported
- Weight at study initiation: 2.4 to 2.8 kg
- Housing: Individually
- Diet (e.g. ad libitum): pellets (Ssniff MU Z, Ssniff Spezialdiaten GmbH); ad libitum
- Water (e.g. ad libitum): drinking water; ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 2
- Humidity (%): 50 to 85
- Photoperiod (hrs dark / hrs light):12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 30 to 60 minutes, 24, 48, and 72 hours
- Number of animals:
- 3 animals
- Details on study design:
- TEST SITE
- Area of exposure: ca. 6 cm squared on the back of each animals
- Type of wrap if used: semi-occlusive dressing, which was held in place by non-irritating tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the exposure period, the dressing was removed and any residual sample was carefully washed away with water or an appropriate solvent.
- Time after start of exposure: 4h
SCORING SYSTEM: Same scale as the one provided in the OECD guideline
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 30 to 60 min, 24, 48, and 72 hr
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 30 to 60 min, 24, 48, and 72 hr
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 30 to 60 min, 24, 48, and 72 hr
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 30 to 60 min, 24, 48, and 72 hr
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 30 to 60 min, 24, 48, and 72 hr
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 30 to 60 min, 24, 48, and 72 hr
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
Applicant's summary and conclusion
- Interpretation of results:
- other: Not Classified
- Remarks:
- Criteria used for interpretation of results: other: CLP (EC 1272/2008)
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