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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
(2001)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Strain: Sprague Dawley CD (Crl: CD (SD) IGS BR)
- Source: Charles River Ltd, Margate, Kent, UK.
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: The bodyweights fell within an interval of +/- 20% of the mean initial bodyweight of the first treated group.
- Housing: in groups of 3 in suspended solid-floor polypropylene cages furnished with woodflakes.
- Fasting period before study: An overnight fast immediately before dosing and for approximately three to four hours after dosing.
- Diet and water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%):30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
ADMINISTRATION VOLUME APPLIED: 10 mL/kg

VEHICLE
- Arachis oil BP; For the purpose of the study the test material was freshly prepared, as required, as a solution at the appropriate concentration in arachis oil BP.
- Concentration in vehicle: 200 mg/mL

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: After surveying all available information on the toxicity of the test material, 2000 mg/kg was chosen as the starting dose.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6 (3 animals per step)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: 30 min., 1, 2 and 4 hours after dosing and subsequently once daily
- Frequency of weighing: prior to dosing and seven and fourteen days after treatment or at death.
- Necropsy of survivors performed: yes
Statistics:
Using the mortality data obtained, an estimate of the acute oral median lethal dose of the test material was made according to the scheme of OECD TG 423.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 500 mg/kg bw
Mortality:
There were no deaths.
Clinical signs:
There were no signs of systemic toxicity.
Body weight:
All animals showed expected gains in bodyweight over the study period.
Gross pathology:
No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Executive summary:

An acute oral toxicity study according to the Acute Toxic Class Method (OECD TG 423) was performed on 3 + 3 female rats, receiving each a single dose of 2000 mg/kg of the substance. No mortalities, no signs of systemic toxicity and no effects on body weight gain were observed. At necropsy no abnormalities were noted. The LD50 of the test material was estimated according to the flow chart of the OECD TG 423, Annex 2d to be > 2500 mg/kg bw.