Registration Dossier
Registration Dossier
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EC number: 951-779-7 | CAS number: -
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given, but considered sufficiently reliable for the purpose of hazard assessment.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1975
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Documentation insufficient for assessment
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Principles of method if other than guideline:
- Method according to the typical testing for acute dermal toxicity in a limit test: topical application of substance on rabbits at one high dose.
- GLP compliance:
- no
- Remarks:
- (pre-GLP)
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- No data
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg bw - Duration of treatment / exposure:
- Single treatment (24 h exposure)
- Observation period:
- 14 days
- Number of animals:
- Total: 2 animals
- Details on study design:
- No data
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Remarks on result:
- probability of moderate irritation
- Irritant / corrosive response data:
- - No mortality was observed
- moderate redness in 2 animals.
- slight edema in 1 animal and moderate edema in another one. - Other effects:
- - No other clinical signs were observed
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Under the test conditions, the test substance induced slight to moderate skin irritation in rabbits.
- Executive summary:
In an acute dermal toxicity study (limit test), two rabbits were given a single dermal application of the test material at a dose level of 5000 mg/kg bw. Animals were observed for mortality and clinical signs for 14 days.
No mortality occurred during the study. No clinical signs were observed. Moderate redness was observed in two animals, slight edema in one rabbit and moderate edema in another.
Under the test conditions, the test substance induced slight to moderate skin irritation in rabbits.
This study was conducted according to a non-standard method and adequate scoring of skin effects was not provided, therefore it was not possible to take a decision on the classification based solely on this study.
Acute dermal LD50 of test material was higher than 5000 mg/kg bw
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
- Principles of method if other than guideline:
- - Standard acute method (limit test)
- GLP compliance:
- no
- Remarks:
- (pre GLP)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Absolute of Nicotiana tabacum (Solanaceae) obtained from leaves by organic solvent treatment and subsequent ethanol extraction
- EC Number:
- 951-779-7
- Molecular formula:
- Not relevant, UVCB substance
- IUPAC Name:
- Absolute of Nicotiana tabacum (Solanaceae) obtained from leaves by organic solvent treatment and subsequent ethanol extraction
- Test material form:
- other: Semi-solid
- Details on test material:
- - Description: A dark brown, semi-solid mass
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No data.
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- No data.
- Duration of exposure:
- 24 h
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- Total: 2
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: Clinical observations, observations for mortality and toxic effects were made daily for 14 days
- Necropsy of survivors performed: No data - Statistics:
- None
Results and discussion
- Preliminary study:
- Not applicable
Effect levels
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality was observed.
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: - No signs of systemic toxicity were noted during the observation period. - Dermal reactions: moderate redness in 2, slight edema in 1 and moderate edema in 1.
- Gross pathology:
- No data available.
- Other findings:
- No data.
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the dermal LD50 for test substance is higher than 5000 mg/kg bw in rabbits. Therefore, the substance is not classified according to the annex I of the Regulation EC No. 1272/2008 (CLP) and to the GHS.
- Executive summary:
In an acute dermal toxicity study (limit test), two rabbits were given a single dermal application of the test material at a dose level of 5000 mg/kg bw. Animals were observed for mortality and clinical signs for 14 days.
No mortality occurred during the study. No clinical signs were observed. Moderate redness was observed in two animals, slight edema in one rabbit and moderate edema in another. In this study, the dermal LD50 of Tabac absolute was higher than 5000 mg/kg bw in rabbits.
Under the test conditions, the dermal LD50 for test substance is higher than 5000 mg/kg bw in rabbits. Therefore, the test substance is not classified
according to the annex I of the Regulation EC No. 1272/2008 (CLP) and to the GHS.
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