Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1977
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:
other: Details of the guideline followed not given
GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Test substance administered at 60%.
Doses:
3.67g/kg, 4.44g/kg, 5.17g/kg and 6.52g/kg.
No. of animals per sex per dose:
10 female ; 10 male.
Control animals:
no
Statistics:
LD50 values were calculated for 24 hours and 7 days using Litchfield-Wilcoxon method.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 2 800 mg/kg bw
Based on:
other: converted to pure substance
Mortality:
There were no deaths at the lowest dose level. At 4.44 g/kg, 4 animals of each sex died after 24 hours or 7 days and at 5.17 g/kg 6 males and 7 females died in 24 hours or 7 days. All animals in the 6.52 g/kg group died.
Clinical signs:
The toxicological symptoms were described as sedation, myosis, dyspnoea, tremors and cramping.
Body weight:
No significant change in body weight during the first 7 days or other signs of toxicity at the lowest dose level. The two mid dose groups showed 6-12% decrease in mean body weight development.
Gross pathology:
No pathological findings were reorted for any test groups.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the experimental conditions the calculated LD50 for males was 4.81 g/kg 60% substance and for females 4.70 g/kg 60% substance. Converted to pure substance the respective LD50 value is approximately 2800 mg/kg. In accordance with Directive 67/548 and Regulation (EC) No 1272/2008 the substance is not classified.
Executive summary:

The calculated LD50 for males was 4.81 g/kg 60% substance and for females 4.70 g/kg 60% substance. Converted to pure substance the respective LD50 value is approximately 2800 mg/kg. In accordance with Directive 67/548 and Regulation (EC) No 1272/2008 the substance is not classified.