Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1993
Reliability:
1 (reliable without restriction)

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
Active su
Specific details on test material used for the study:
The test material was supplied as dark brown liquid, stored at room temperature.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Male and female Sprague-Dawley strain rats weighed 147-176 g, and 140-152 g respectively and were approximately five to eight weeks old. They were separated by sex. Room temperature 19-22ÂșC and humidity of 44-58%

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
All animals were dosed once only by gavage using a metal cannula attached to a graduate syringe.
Doses:
The volume administrated to each animal was calculated according to its fasted bodyweight at the time of dosing.
No. of animals per sex per dose:
5 male, 5 female
Control animals:
yes
Details on study design:
The animals were observed for death or overt signs of toxicity 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
There were no deaths.
Clinical signs:
No signs of systemic toxicity were noted during the study.
Body weight:
All animals showed expected gain in bodyweight during the study
Gross pathology:
No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acure oral median lethal dose (LD50) of the test materials, HMPPJC, in the Sprague-Dawley strain rat was found to be greater than 2000 mg/kg bodyweight. No symbol and risk phrase are required according to EEC labelling regulations.