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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:
3 March 1999 - 21 June 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guideline
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:
other: Crl:CD(SD)IGS BR
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles river Laboratories, Raleigh, NC
- Age at study initiation: 10-11 weeks (males), 11-12 weeks (females)
- Weight at study initiation: 274-353g (males), 212-262g (females) at initiation of dosing
- Housing: individually suspended wire-mesh cages.
- Diet: PMI Nutrition International, Inc. Certified Rodent LabDiet 5002, ad libitum
- Water: reverse osmosis treated municipal water, ad libitum
- Acclimation period: minimum of 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.1-22.3
- Humidity (%): 45-56
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
No data available.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5M, 5F
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: The test animals were observed for overt signs of toxicity at 1, 3, and 4 hours, and once daily thereafter for 14 days.  Animals were observed twice daily for mortality.  Body weights were recorded on Days 0, 7, and 14.

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Examination of the cranial, thoracic, and abdominal cavities was carried out after sacrificing the animals.
Statistics:
No data available.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
One male and one female died during the first week of dosing.
Clinical signs:
A majority of the rats were noted with various discoloured areas due to discharges/excretions. Other findings in approximately one-third of the animals included abnormal excretion, hypoactivity and tremors.
Body weight:
No data.
Gross pathology:
Gastrointestinal abnormalities were noted for one animal that died.
Other findings:
No other findings reported.

Any other information on results incl. tables

Based on these results, the acute oral LD50 of A-172 was determined to be greater than 2000 mg/kg, indicating a very low order of toxicity in the rat by this route.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
An acute oral LD50 value of >2000 mg/kg for rats was determined in a reliable study conducted according to an aapropriate test protocol, and in compliance with GLP.