D-tetramethrin

Acute Toxicity: oral

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

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(1,3,4,5,6,7-hexahydro-1,3-dioxo-2H-isoindol-2-yl)methyl (1R-trans)-2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate

EC Number:

214-619-0

EC Name:

(1,3,4,5,6,7-hexahydro-1,3-dioxo-2H-isoindol-2-yl)methyl (1R-trans)-2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate

Cas Number:

1166-46-7

Molecular formula:

C19H25NO4

IUPAC Name:

(1,3-dioxo-1,3,4,5,6,7-hexahydro-2H-isoindol-2-yl)methyl (1R,3R)-2,2-dimethyl-3-(2-methylprop-1-en-1-yl)cyclopropanecarboxylate

Constituent 2

Reference substance name:

(1,3,4,5,6,7-hexahydro-1,3-dioxo-2H-isoindol-2-yl)methyl (1R-cis)-2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate

EC Number:

257-144-4

EC Name:

(1,3,4,5,6,7-hexahydro-1,3-dioxo-2H-isoindol-2-yl)methyl (1R-cis)-2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate

Cas Number:

51348-90-4

Molecular formula:

C19H25NO4

IUPAC Name:

(1,3-dioxo-1,3,4,5,6,7-hexahydro-2H-isoindol-2-yl)methyl (1R,3S)-2,2-dimethyl-3-(2-methylprop-1-en-1-yl)cyclopropanecarboxylate

Constituent 3

Reference substance name:

1,3-dioxo-1,3,4,5,6,7-hexahydro-2H-isoindol-2-yl)methyl (1S,3S)-2,2-dimethyl-3-(2-methylprop-1-en-1-yl)cyclopropanecarboxylate

Cas Number:

1166-48-9

Molecular formula:

C19H25NO4

IUPAC Name:

1,3-dioxo-1,3,4,5,6,7-hexahydro-2H-isoindol-2-yl)methyl (1S,3S)-2,2-dimethyl-3-(2-methylprop-1-en-1-yl)cyclopropanecarboxylate

Constituent 4

Reference substance name:

(1,3-dioxo-1,3,4,5,6,7-hexahydro-2H-isoindol-2-yl)methyl (1S,3R)-2,2-dimethyl-3-(2-methylprop-1-en-1-yl)cyclopropanecarboxylate

Cas Number:

51348-91-5

Molecular formula:

C19H25NO4

IUPAC Name:

(1,3-dioxo-1,3,4,5,6,7-hexahydro-2H-isoindol-2-yl)methyl (1S,3R)-2,2-dimethyl-3-(2-methylprop-1-en-1-yl)cyclopropanecarboxylate

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 or test system 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.