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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11/1973 - 12/1973
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
OECD 401: at least 5 rodents of each sex in each group; at least three dose levels; limit test at least 2000 mg/kg b.w. This Study: 10 rats of each sex in each group; 6 dose levels, spaced with factor 1.26
GLP compliance:
not specified
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity
Type:
impurity
Test material form:
solid: bulk
Details on test material:
This composition is the usual techical grade of AlzChem AG. It will be used when test substance has this composition (or is very closed) or no specific information is available

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Surviving animals were held in macrolon cages (B II) at 24.0 +/- 0.5 °c and 60 +/- 3 % relative humidity.
During 4 weeks after treatment behaviour, feed and water intake and body weigth were observed.
After 4 weeks animals were dissectet and examinded macroscopic.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 1 % aequous methyl-hydroxyethylcellulose gel MH300
Doses:
Lowest dose: 504 mg/kg b.w.
Step per dose: factor 1.26
Highest dose: 1590 mg/kg b.w.
No. of animals per sex per dose:
10
Control animals:
no
Statistics:
Litchfield and Wilcoxon

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 1 190 mg/kg bw
Based on:
test mat.
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 1 210 mg/kg bw

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Median lethal dose (LD50)
- Male rats: 1190 (1090 - 1300) mg/kg b.w.
- Female rats: 1210 (1110 - 1320) mg/kg b.w.
Executive summary:

Symptoms of intoxication showed:

- Sedation

- ataxis (635 mg/kg b.w.)

- reduced feed intake (1000 mg/kg b.w.)

- abdominal position

- slow and breathing

- tonic-clonic spasms (1260 mg/kg b.w.)

Death occured within 2 and 24 h after after treatment after tonic-clonic spasms.

Lowest lethal dose: 1000 mg/kg b.w.

Surviving animals recovered within 2 d.

Necopsy showed pale and parencymatic organs in animals that died after treatment. Other animals showed no pahological findings.