Registration Dossier
Registration Dossier
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EC number: 210-484-7 | CAS number: 616-47-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- pre-GLP, pre-OECD guideline, occlusive exposure for 1, 5, 15 min and 20 h, observation period 8 days.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 966
- Report date:
- 1966
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- Method: BASF-Test: Animals were treated for 1, 5, 15 min and 20 hours using occlusive conditions. An application site of 2.5x2.5 cm was covered with the liquid test substance. After the application time (1, 5, 15 min and 20 hours) the skin was washed with Lutrol (50%). The animals were observed for 8 days and skin changes were recorded daily. The report describes findings after 24 hours and at the end of the observation period (8 days). For a final evaluation, the findings after 48 h and 72 h from the raw data were taken into account.
- GLP compliance:
- no
Test material
- Reference substance name:
- 1-methylimidazole
- EC Number:
- 210-484-7
- EC Name:
- 1-methylimidazole
- Cas Number:
- 616-47-7
- Molecular formula:
- C4H6N2
- IUPAC Name:
- 1-methyl-1H-imidazole
- Test material form:
- liquid
- Details on test material:
- Substance name: 1-Methylimidazol (flüssig)
Substance number: XVI/41
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Duration of treatment / exposure:
- 1, 5 , 15 min and 20 h
- Observation period:
- 8 d
- Number of animals:
- 2
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm (patch test)
REMOVAL OF TEST SUBSTANCE
- After the application time the skin was washed with Lutrol (50%).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- 1 min of exposure
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: scaling (scoring after 8 days not possible)
- Irritation parameter:
- erythema score
- Remarks:
- 5 min of exposure
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: necrosis (scoring after 8 days not possible), hardening of the skin
- Irritation parameter:
- erythema score
- Remarks:
- 15 min of exposure
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: severe necrosis (scoring after 8 days not possible)
- Irritation parameter:
- erythema score
- Remarks:
- 20 h of exposure
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: severe necrosis (scoring after 8 days not possible), scarring of the skin
- Irritation parameter:
- edema score
- Remarks:
- 1 min of exposure
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: scaling (scoring after 8 days not possible)
- Irritation parameter:
- edema score
- Remarks:
- 5 min of exposure
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: necrosis (scoring after 8 days not possible), hardening of the skin
- Irritation parameter:
- edema score
- Remarks:
- 15 min of exposure
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: severe necrosis (scoring after 8 days not possible)
- Irritation parameter:
- edema score
- Remarks:
- 20 h of exposure
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: severe necrosis (scoring after 8 days not possible), scarring of the skin
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Remarks:
- Harmonised classification - Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation): Index no. 613-035-00-7: Skin Corr. 1B;H314
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