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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
No guideline was specified. Dosing by gavage of the test substance, suspended in water for irrigation, to groups of 10 male and female mice to determine toxic effects from oral exposure to the substance.
GLP compliance:
no
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
additive
Test material form:
solid: particulate/powder
Details on test material:
Moisture content 0.16% w/w (Karl FIscher) as supplied to laboratory.
Batch Number: G309569

Test animals

Species:
mouse
Strain:
other: CRH (Glaxo Group Research Limited, Harefield Breeding Unit)
Sex:
male/female
Details on test animals and environmental conditions:
Weight range: 16-20g.
Not starved prior to treatment

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
Irrigation water
Details on oral exposure:
Material was formulated as a suspension in Water for Irrigation, using a Silverson blender, and dosed by gavage at a dose volume of 1ml/20g, to groups of 10 male and 10 female mice.
Doses:
1ml suspension / 20 g of animal
1000 mg/kg
No. of animals per sex per dose:
10
Control animals:
not specified
Details on study design:
Observation period: 14 days

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 1 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
No animals died due to ingestion of the test material.
Clinical signs:
Nothing abnormal detected
Body weight:
Nothing abnormal detected
Gross pathology:
No significant lesions were seen at autopsy although Kidneys of 5 males and 6 females were slightly pale. These tissues were submitted for histopathological examination and were found to be microscopically normal.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
'Trityl DMF solvate' has a low order of acute oral toxicity in mice with an LD50 value in excess of 1000 mg/kg. No signs of toxicity were seen at that dose level.
Executive summary:

Dosing by gavage of the test substance, suspended in water for irrigation, to groups of 10 male and female mice to determine toxic effects from oral exposure to the substance, showed no toxicity up to a dosage of 1000 mg/kg body weight.