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:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was not conducted according to guideline/s and GLP, but the report contains sufficient data for interpretation of study results.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Three female Fischer 344 rats received 2000 mg/kg of the neat test material by single-dose oral gavage. Observations and body weights were recorded over a 2-week period following dosing.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test material: Dowfax 2A1
Source: Specialty Chemicals, The Dow Chemical Company
Properties: Amber liquid
pH= 7.0

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
female
Details on test animals and environmental conditions:
No data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
2000 mg/kg of the neat test material by single-dose oral gavage
Doses:
2000 mg/kg
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
Three female Fischer 344 rats received 2000 mg/kg of the neat test material by single-dose oral gavage. Observations and body weights were recorded over a 2-week period following dosing.
Statistics:
None

Results and discussion

Preliminary study:
None
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality
Clinical signs:
Clinical signs indicative of systemic toxicity in the 2000 mg/ kg dose level consisted of fecal and urine soiling, salivation, chromorhinorrhea, decreased activity, and thin appearance. The clinical signs were first observed two hours post dose and persisted through test day four.
Body weight:
While one of the rats initially lost weight, all animals gained weight over the two week observation period.
Gross pathology:
None
Other findings:
No data

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Criteria used for interpretation of results: other: EU GHS
Conclusions:
The estimated acute oral LD50 for female Fischer 344 rats was greater than 2000 mg/kg.
Executive summary:

A sample of Dowfax 2A1 was submitted by Specialty Chemicals, The Dow Chemical Company, Midland, MI for evaluation of acute oral and dermal toxicity and skin and eye irritation.

In the acute oral toxicity test, three female Fischer 344 rats received 2000 mg/kg of the neat test material by single-dose oral gavage. Clinical signs indicative of systemic toxicity in the 2000 mg/kg dose level consisted of fecal and urine soiling, salivation, chromorhinorrhea, decreased activity, and thin appearance. The clinical signs were first observed two hours post dose and persisted through test day four. While one of these rats initially lost weight, all animals gained weight over the two-week observation period. The estimated acute oral LD50 for female Fischer 344 rats was greater than 2000 mg/kg.