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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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Rapporteur for the EU risk assessment of (3-chloro-2-hydroxypropyl)trimethylammonium chloride is the National Product Control Agency for Welfare and Health, Finland. The report is the result of in-depth work performed by experts in one Member State, working with counterparts in other Member States, Industry and public interest groups. The information reported is considered reliable.

Data source

Reference
Reference Type:
other: Published secondary source
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 79/831/EEC Annex V guideline
GLP compliance:
not specified
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
(3-chloro-2-hydroxypropyl)trimethylammonium chloride
EC Number:
222-048-3
EC Name:
(3-chloro-2-hydroxypropyl)trimethylammonium chloride
Cas Number:
3327-22-8
Molecular formula:
C6H15ClNO.Cl
IUPAC Name:
3-chloro-2-hydroxy-N,N,N-trimethylpropan-1-aminium chloride

Test animals

Species:
rat
Strain:
other: CD rat
Sex:
male/female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
Test substance administered as a 65% solution.
Duration of exposure:
24 hours
No. of animals per sex per dose:
Five female ; Five male
Control animals:
not specified

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths during the whole observation period.
Clinical signs:
other: No clinical signs were observed during the whole observation period.
Gross pathology:
In the post mortem examination, the macroscopic appearance of abnormal organs was recorded. There were no abnormal autopsy findings.

Applicant's summary and conclusion

Conclusions:
The acute lethal dermal dose to rats was found to be greater than 2000 mg/kg.
Executive summary:

A test performed according to the 79/831/EEC Annex V guideline investigated the acute dermal toxicity of (3-chloro-2-hydroxypropyl)trimethylammonium chloride in five female and five male CD rats. The acute lethal dermal dose to rats was found to be greater than 2000 mg/kg.