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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: no GLP study No OECD and EU guidelines were followed.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Method: a) Range finder: Initially, groups of two rats were given a single oral dose of the undiluted test material by gavage using an all metal stomach tube.
b) Animals were each given a single oral dose of the test material at the specified level. animals were observed at 1/4, 1 and 4 hours after treatment and then once daily for fourteen days and the mortalities recorded. Evidence of overt toxicity was also noted.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: A . Tuck and Sons Limited, Battlesbridge, Essex
- Weight at study initiation: 150 - 300 g
- Fasting period before study: yes, overnight
- Housing: Animals were housed by sex in suspended metal cages with mesh floors. A maximum number of five rats were housed in each cage.
- Diet: ad libitum, Rat Diet, supplied by Nottingham University, School of Agriculture, Sutton Bonington, Nr . Louqhborough, Leics .
- Water: water (mains tap), ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + 3°C
- Air changes (per hr): a minimum of 20 air changes per hour
- Photoperiod (hrs dark / hrs light): the lighting cycle was 14 hours on, 10 hours off

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: a) range finder: 0.05, 0.125, 0.25 mL/kg; b) main test: 0.058, 0.05, 0.085, 0.146, 0.25 mL/kg
- Amount of vehicle: 400 mg/mL
Doses:
a) range finder: 20, 50, 100 mg/kg bw
b) main test: 11.69, 20, 34.2, 58.5, 100 mg/kg bw
No. of animals per sex per dose:
a) range finder: 1
b) main test: 5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days (main test)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
26.15 mg/kg bw
Based on:
test mat.
95% CL:
20.41 - 33.51
Clinical signs:
No overt signs of toxicity were oberseved in any of the animals dosed at 11.69 mg/kg bw. At the 20.0 mg/kg bw and 34.2 mg/kg bw dose levels symtoms consisted of subdued activity, pilar erection and anorexia. Survivors at both dose levels showed a marked reduction in bodyweight gain throughout the fourteen day observation period, and two rats at 34.2 mg/kg bw showed pilar erection to days 12 and 14 respectively.
Symptoms at the 58.5 mg/kg bw level consisted of subdued an activity, pilar erection and collapse prior to death. Similar effects were observed in the 100 mg/kg bw group with animals also showing body tremors 4 hours after dosing.
Gross pathology:
Survivors at 20.0 mg/kg bw and 34.2 mg/kg bw showed evidence of anorexia, that is significantly reduced bodyweight gain. Gross necropsy of survivors (one male and one female from each group)revaled no abnormal macroscopic lesions.

Applicant's summary and conclusion