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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Study period:
24 hours exposure; 14 day observation
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
US EPA source considered reliable
Test performed on analogue substance; non-phosphated form
Although headline result is LD50 > 2 g/kg, it is uncertain if this relates to the active or to a diluted test material.
However, the EPA have judged the result as 'valid without restrictions' and cited 2 g/kg.

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
1987

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
Limit test
GLP compliance:
not specified
Test type:
standard acute method
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:
{[3-(Dodecanoylamino)propyl](dimethyl)ammonio}acetate
Specific details on test material used for the study:
Source not specified. Activitiy not specified (not known if test material was a diluted form)

Test animals

Species:
rat
Strain:
CD-1
Sex:
male/female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 hours
Doses:
2000 mg/kg (assumed actives)
No. of animals per sex per dose:
Five
Control animals:
not specified

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No
Clinical signs:
other: Local irritation
Gross pathology:
No adverse effects on termination

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Local irritation, but this resolved during the observation periods
Although headline result is LD50 > 2 g/kg, it is uncertain if this relates to the active or to a diluted test material.
However, the EPA have judged the result as 'valid without restrictions' and cited 2 g/kg.