1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts

Acute Toxicity: oral

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

Reference

Reference 1

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 2

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 3

Reference Type:

other: secondary source

Title:

Acute oral toxicity of test chemical in rat.

Author:

HPVIS

Year:

2018

Bibliographic source:

HPVIS, 2018

Reference 4

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 5

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

Test material information

Constituent 1

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:

other: 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,

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.