Registration Dossier
Registration Dossier
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EC number: 268-771-8 | CAS number: 68140-01-2
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)
Data source
Reference
- Reference Type:
- publication
- Title:
- Fatty acid amido propyl dimethylamines: Human health tier II Assessment
- Author:
- NICNAS
- Year:
- 2 019
- Bibliographic source:
- NICNAS Health Assessment
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- not specified
- Remarks:
- Not specified in the NICNAS report
Test material
- Reference substance name:
- Amides, coco, N-[3-(dimethylamino)propyl]
- EC Number:
- 268-771-8
- EC Name:
- Amides, coco, N-[3-(dimethylamino)propyl]
- Cas Number:
- 68140-01-2
- IUPAC Name:
- Amines, C12-18, alkyldimethyl
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- undiluted chemical
Test animals
- Species:
- rabbit
- Details on test animals or test system and environmental conditions:
- Animals are individually housed. The temperature of the experimental animal room is around 20°C for rabbits.
The relative humidity is around 50-60%.
Lighting is artificial, the sequence being 12 hours light, 12 hours dark.
For feeding, conventional laboratory diets is used with an unrestricted supply of drinking water.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Remarks:
- Approximately 24 hours before the test, fur was removed by closely clipping the dorsal area of the trunk of the animals.
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 30 minutes exposure
- Number of animals:
- 5
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- ca. 5
- Max. score:
- 5
- Reversibility:
- not specified
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- ca. 5
- Max. score:
- 5
- Reversibility:
- not specified
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 5
- Max. score:
- 5
- Reversibility:
- not specified
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- >= 4
- Max. score:
- 5
- Reversibility:
- not specified
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- ca. 3
- Max. score:
- 5
- Reversibility:
- not specified
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- ca. 3
- Max. score:
- 5
- Reversibility:
- not specified
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 3
- Max. score:
- 5
- Reversibility:
- not specified
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 3
- Max. score:
- 5
- Reversibility:
- not specified
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- overall irritation score
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 3
- Max. score:
- 5
- Reversibility:
- not specified
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 4
- Max. score:
- 5
- Reversibility:
- not specified
- Remarks on result:
- probability of severe irritation
- Irritant / corrosive response data:
- Intense erythema, crust development, necrotic skin alteration and moderate oedema were observed.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- Under the test condition, the chemical was considered to be corrosive to skin. No other details of the study are available.
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