Registration Dossier
Registration Dossier
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EC number: 459-550-9 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Nov 29th to Dec 2nd 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, performed in conformity with GLP-principles
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes (incl. QA statement)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- Name of test material (as cited in study report): P5497 (identical with L-Carnitine-L-Tartrate)
- Physical state: white, fine powder
- Purity test date: not indicated
- Lot/batch No.: 13
- Stability under test conditions: stable
- Storage condition of test material: ambient temperature
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 Bremervoerde, Neuendamm 88/Germany
- Housing: individual housing
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): Artificial lighting (120 lux) from 7.00 a.m. - 7.00 p.m.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Remarks:
- the test substance was moistened with the vehicle
- Controls:
- no
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- Signs of erythema and oedema were recorded at 30-60 min, 24, 48 and 72 h after patch removal .
- Number of animals:
- 3 animals
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- No signs of irritation oberved during the study.
- Other effects:
- There were no signs of toxicity, irritation or ill health observed in any animal throughout the study.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item was found to be non-irritant to rabbit skin. Based on these results, the test item does not have to be classified and has no obligatory labelling requirement for skin irritation according to the European CLP-Regulations (GHS).
- Executive summary:
The test item was tested for skin irritation on rabbits according to OECD-Guideline No. 404, EU-Testing Method B.4 and in conformity with GLP-principles. The study was performed from November 29 - December 2, 1990.
The test item was found to be non-irritant to rabbit skin. Based on these results, the test item does not have to be classified and has no obligatory labelling requirement for eye irritation according to the European CLP-Regulations (GHS).
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