Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Acute oral toxicity was determined according to OECD Guideline 401 (Acute Oral Toxicity Test) and the EU Method B.1

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Sesame oil
Doses:
Dose : 2000 mg/Kg bodyweight
Concentration 20% in sesame oil (w/v)
Application volume 10mL/Kg bodyweight.
No. of animals per sex per dose:
Male: 5
Female: 5
Control animals:
yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
One of the females died after 2 days.
Clinical signs:
Males: irregular respiration, Stilted gait, Squatting posture and derc. spontaneous activity the first day.
Afterwards, there were no abnormalities detected until the end of the experiment (14 days).
Similarly for females with these symptoms and more the first day: Flanks drawn in, Coat bristling and uncoordinated gait.
Afterwards, females showed no abnormalities until the end of the experiment (14 days).
Body weight:
Average weight starting:
Male 185g
Female 180g
Mean weight at 14 days:
Male 88.8g
Female 40.5g
Gross pathology:
After the end of the experiment, animals have been killed for dissection which has no showed macroscopically visible features.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
5-Methylisoxazole-4-carboxylic acid is not classified harmful by oral route.