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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:
2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
the racemate is characterized by CAS-number 7696-12-0
Specific details on test material used for the study:
Batch No. TT-SF-01-001

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Toxicology Department, Rallis Research Centre Bangalore-560 058, INDIA
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 15 weeks
- Weight at study initiation: Females : 175 - 200 g; Males : 253 - 283 g
- Housing: Individually housed in standard polypropylene cages (size: L 290 x W 220 x H 140 mm), with stainless steel top grill having facilities for pelletted food and drinking water in glass bottle. bedding: steam sterilized clean paddy husk was used and changed twice a week.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: Seven (G1F and G2F) and eight (G1M and G2M) days under laboratory conditions after veterinary examination.

ENVIRONMENTAL CONDITIONS
- Temperature: 19 - 24 °C
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 h light and 12 h darkness

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Amount of vehicle (if gavage): 2000 mg/kg bw
- Justification for choice of vehicle: Since, the test item is a crystalline powder and is practically insoluble in water, corn oil (as preferred by the sponsor) was used as a vehicle.

MAXIMUM DOSE VOLUME APPLIED: 5 ml/kg bw

CLASS METHOD (if applicable)
- The test was started as per Annex 1c of the test guideline i.e. the starting dose was 2000 mg/kg body weight which is considered as the dose where the mortalities are most likely be produced.
Doses:
2000 mg/kg bw of both test item and control vehicle
No. of animals per sex per dose:
3 male + 3 females exposed to 2000 mg/kg bw of test item and control vehicle
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing:
Pre-terminal deaths: four times on test day one and once daily during days 2-15.
Body weights: test days: 1 (pre-administration), 8 and 15 days post treatment.
Toxic signs: four times on the test day one and once daily during days 2 - 15
- Necropsy of survivors performed: yes

Results and discussion

Preliminary study:
Limit test has been performed
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no pre-terminal deaths.
Clinical signs:
There were no toxic signs.
Body weight:
Body weights of all the rats increased through the observation period.
Gross pathology:
There were no gross necropsy findings in any of the rats.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral LD50 of tetramethrin tech. grade in Wistar rats is more than 2000 mg/kg body weight

Executive summary:

Acute oral toxicity (Acute toxic class method) of tetramethrin tech. grade was tested in female and male Wistar rats. The test item was suspended in corn oil and administered as a single oral dose to overnight fasted (17 - 18 hours) Wistar rats (3 rats/sex/group) at the doses of '0' ('vehicle control group' G1 - females and males) and 2000 (G2 females and males) mg/kg body weight and the rats were observed for 15 days post treatment. There were no toxic signs and pre-terminal deaths in both the groups of both sexes. The acute oral minimal lethal dose of tetramethrin tech. grade in Wistar rats is more than 2000 mg/kg body weight as per the interpretation of results based on Annex 1c, Option 1 testing of OECD Guideline No. 423, adopted on 22.03.1996.