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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from secondary source.

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., inner salts
Author:
HPVIS
Year:
2018
Bibliographic source:
HPVIS
Reference Type:
secondary source
Title:
Acute Toxicity - Rat
Author:
U.S. Environmental Protection Agency
Year:
2001
Bibliographic source:
U.S. Environmental Protection Agency
Reference Type:
secondary source
Title:
Acute Dermal Toxicity study in Rats
Author:
U.S. Environmental Protection Agency
Year:
2010
Bibliographic source:
U.S. Environmental Protection Agency
Reference Type:
secondary source
Title:
Cocamidopropyl betaine (CAPB)
Author:
Human and Environmental Risk Assessment
Year:
2005
Bibliographic source:
Human and Environmental Risk Assessment
Reference Type:
secondary source
Title:
Alkylamidopropyl betaines
Author:
OECD SIDS
Year:
2006
Bibliographic source:
OECD SIDS

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
Acute dermal toxicity of 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts (CAS no.: 61789-40-0) in rat.
GLP compliance:
not specified
Test type:
other: Acute Dermal Toxicity
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- IUPAC Name: 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts- Common Name: Cocamidopropyl Betaine- Smiles: CCCCCCCCCCCC(=O)NCCCN{+} (C)(C)CC(=O)O{-}- Molecular formula:C19H38N2O3- Molecular weight :342.52 g/mole- Substance type:Organic- Physical state:liquid- Purity: 31% active ingredient
Specific details on test material used for the study:
- IUPAC Name: 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts- Common Name: Cocamidopropyl Betaine- Smiles: CCCCCCCCCCCC(=O)NCCCN{+} (C)(C)CC(=O)O{-}- Molecular formula:C19H38N2O3- Molecular weight :342.52 g/mole- Substance type:Organic- Physical state:liquid- Purity: 31% active ingredient

Test animals

Species:
rat
Strain:
other: CD [Crl:COBS CD (SD) BR] rats
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS- Weight at study initiation: weighing range of 200 to 232 g prior to dosing.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
not specified
Details on dermal exposure:
not specifiedTEST SITE - Area of exposure: dorsolumbar region - % coverage: 10% of the total body surface - Type of wrap if used: The treated area was then promptly covered with gauze, which was held in place with an impermeable dressing encircled firmly around the trunk. REMOVAL OF TEST SUBSTANCE - Washing (if done): The dressings were carefully removed and the treated area of skin decontaminated by washing in warm (30 - 40 °C) water and blotting dry with absorbent paper. - Time after start of exposure:24-hour
Duration of exposure:
24 hour
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Total = 10 (5 male and 5 female rats)
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 15 days - Frequency of observations and weighing: The treated areas of skin were examined daily for 14 days for signs of dermal irritation and assessed according to an arbitrary scoring system. Individual body weights of rats in the study were recorded on Days 1, 8 and 15. - Necropsy of survivors performed: yes, all animals were killed on Day 15 by cervical dislocation and were subjected to a macroscopic post mortem examination, which consisted of opening the abdominal and thoracic cavities. The macroscopic appearance of abnormal organs when present was recorded.
Statistics:
not specified

Results and discussion

Preliminary study:
not specified
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality was observed
Mortality:
No mortality was observed at 2000 mg/kg bw
Clinical signs:
There were no clinical signs of systemic reaction t to treatment. Sites of application of the test substance showed slight or well-defined erythema on Day 2. Well-defined erythema persisted in three male and all female rats on Day 3. There were no more intense reactions to treatment, and resolution of erythema was completed by Day 6. Slough or hyperkeratinization affected the treated skin of 4, 5, 6, 8, 9 and 10 rats on Days 4 and 5 only.
Body weight:
not specified
Gross pathology:
Terminal autopsy findings were normal.
Other findings:
not specified

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Conclusions:
Acute dermal toxicity dose (LD50) value was considered to be >2000 mg/kg bw, when 10 male and female CD rats were treated with 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts (Cocamidopropyl Betaine)(CAS no.: 61789-40-0) by dermal application occlusively.
Executive summary:

Acute dermal toxicity study was conducted according to OECD guideline 402 by using test chemical 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts(Cocamidopropyl Betaine) (CAS no.: 61789-40-0) in 10 male and female CD rats at the dose concentration of 2000 mg/kg bw. One day prior to treatment, hair was removed from the dorsolumbar region of each rat with electric clippers exposing an area equivalent to 10% of the total body surface. No shaving or chemical depilation was used. The test substance (31% active ingredient) was applied by spreading it evenly over the prepared skin. The treated area was then promptly covered with gauze, which was held in place with an impermeable dressing encircled firmly around the trunk. At the end of the 24-hour exposure period, the dressings were carefully removed and the treated area of skin decontaminated by washing in warm (30 - 40 °C) water and blotting dry with absorbent paper. The treated areas of skin were examined daily for 14 days for signs of dermal irritation and assessed according to an arbitrary scoring system. Individual body weights of rats in the study were recorded on Days 1, 8 and 15. Necropsy of survivors was performed. All animals were killed on Day 15 by cervical dislocation and were subjected to a macroscopic post mortem examination, which consisted of opening the abdominal and thoracic cavities. The macroscopic appearance of abnormal organs when present was recorded. No mortality was observed at 2000 mg/kg bw. There were no clinical signs of systemic reaction to treatment. Sites of application of the test substance showed slight or well-defined erythema on Day 2. Well-defined erythema persisted in three male and all female rats on Day 3. There were no more intense reactions to treatment, and resolution of erythema was completed by Day 6. Slough or hyperkeratinization affected the treated skin of 4, 5, 6, 8, 9 and 10 rats on Days 4 and 5 only. Terminal autopsy findings were normal. Hence, LD50 value was considered to be >2000 mg/kg bw, when 10 male and female CD rats were treated with 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts (Cocamidopropyl Betaine) by dermal application occlusively.