Registration Dossier

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
Reliability:
1 (reliable without restriction)

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 81-1 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The substance was tested as a 54.4% solution in water

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
500, 2320, 3410 and 5000mg/kg
No. of animals per sex per dose:
5 animals per sex per dose
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 890 mg/kg bw
Based on:
test mat.
Mortality:
At 500 mg/kg - 0/10
At 2320 mg/kg - 1/10
At 3410 mg/kg - 8/10
At 5000 mg/kg - 9/10
Clinical signs:
Clinical changes noted during the observation period included ataxia, saliva and fecal stains, piloerection, shallow and gasping breathing, slight to severe depression, reddish stains around the eyes and on muzzle and dirty hair coats.
Gross pathology:
The gross necropsy findings in the animals that died were those generally seen in agonal animals. In the animals which survived there were no gross pathological findings.

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 (rat, oral) for Glycoserve II - 2890mg/kg
Executive summary:

The LD50 (rat, oral) for Glycoserve II = 2890mg/kg, equivalent to LD50 (rat; oral) for DMDMH - 1572mg/kg.