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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
08 April 1991
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
24 February 1987
Deviations:
not specified
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure

Test material

Constituent 1
Test material form:
liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
Group I: 3330 mg/ kg bw
Group II: 5550 mg/ kg bw
Group III: 8325 mg/ kg bw
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Preliminary study:
Design: Test with a dose of 5550 mg/ kg bw was conducted on two female rats
Result: No deaths
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 5 639 mg/kg bw
Based on:
test mat.
Mortality:
Mortality after 14 days:
Group I: m 0/5, f 1/5
Group II: m 2/5, f 1/5
Group III: m 4/5, f 5/5
Clinical signs:
other: Group I: decreased: activity increased: squatting positions reversible within 24 h after treatment Group II: decreased: activity/ body tone/ skin turgor/ plantary reflex increased: abnormal gait/ ventral position/ squatting position/ abnormal body postur

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
LD50 > 5000 mg/ kg bw
non-toxic