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Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from handbook

Data source

Referenceopen allclose all

Reference Type:
review article or handbook
Title:
Handbook of Environmental Data on Organic Chemicals
Author:
Karel Verschueren
Year:
2008
Bibliographic source:
Handbook of Environmental Data on Organic Chemicals 2008
Reference Type:
other: secondary source
Title:
Robust Summaries & Test Plans: Test material
Author:
U.S. Environmental Protection Agency
Year:
2001
Bibliographic source:
U.S. Environmental Protection Agency
Reference Type:
other: secondary source
Title:
Acute oral toxicity of test chemical in rat.
Author:
HPVIS
Year:
2018
Bibliographic source:
HPVIS, 2018
Reference Type:
other: secondary source
Title:
Acute oral toxicity of test chemical in rats
Author:
Human and Environmental Risk Assessment
Year:
2005
Bibliographic source:
Human and Environmental Risk Assessment, 2005
Reference Type:
other: secondary source
Title:
Acute oral toxicity of test chemical in rats
Author:
OECD SIDS
Year:
2006
Bibliographic source:
OECD SIDS, 2006

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Acute oral toxicity of test chemical in rat.
GLP compliance:
not specified
Test type:
other: OECD Guideline 401 (Acute Oral Toxicity)
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts
EC Number:
263-058-8
EC Name:
1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts
Cas Number:
61789-40-0
Molecular formula:
C19H38N2O3
IUPAC Name:
1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts
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:Solid- Purity:31% active ingredient

Test animals

Species:
rat
Strain:
other: CD [Crl:COBS CD (SD) BR] rats
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS- Weight at study initiation: Body weights ranged between 110 and 150 gm

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
not specified
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
Total = 10 (per sex per dose: 5)
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days - Frequency of observations and weighing: Animals were observed immediately after dosing and at frequent intervals for the remainder of Day 1. On subsequent days, the animals were observed once in the morning and again at the end of the experimental day. Clinical signs were recorded at each observation. Individual body weights 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:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality was observed
Mortality:
No mortality was observed at 5000 mg/kg bw
Clinical signs:
Signs of reaction to treatment observed in all rats shortly after dosing were: piloerection and increased salivation. Piloerection persisted throughout Day 1 and was accompanied on Day 2 by abnormal body carriage (hunched posture) and diarrhea. Recovery, as judged by external appearance and behavior, was advanced by Day 3 (piloerection alone) and complete by Day 4.
Body weight:
Slightly low body weight gains were recorded for 4 males and 3 females on Day 8. All rats achieved anticipated body weight gains during the second week of the study.
Gross pathology:
Terminal autopsy findings were normal.
Other findings:
not specified

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Conclusions:
Acute oral toxicity dose (LD50) value was considered to be >5000 mg/kg (>1500 mg/kg active ingredient), when 10 male and female CD rats were treated with test chemicalvia oral route.
Executive summary:

Acute oral toxicity study was conducted according to OECD guideline 401 by using test chemical in 10 male and female CD rats at the dose concentration of 5000 mg/kg bw. The given test chemical (31% active ingredient) was administered via oral route.Animals were observed immediately after dosing and at frequent intervals for the remainder of Day 1. On subsequent days, the animals were observed once in the morning and again at the end of the experimental day. Clinical signs were recorded at each observation. Individual body weights 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 5000 mg/kg bw. Signs of reaction to treatment observed in all rats shortly after dosing were: piloerection and increased salivation. Piloerection persisted throughout Day 1 and was accompanied on Day 2 by abnormal body carriage (hunched posture) and diarrhea. Recovery, as judged by external appearance and behavior, was advanced by Day 3 (piloerection alone) and complete by Day 4. Slightly low body weight gains were recorded for 4 males and 3 females on Day 8. All rats achieved anticipated body weight gains during the second week of the study. Terminal autopsy findings were normal. Therefore, LD50 value was considered to be >5000 mg/kg (>1500 mg/kg active ingredient), when 10 male and female CD rats were treated with test chemical via oral route.