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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Feb - May 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP / guideline study without deviations

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Reference substance name:
d-Phenothrin
IUPAC Name:
d-Phenothrin
Constituent 2
Reference substance name:
Cyclopropanecarboxylic acid, 2,2-dimethyl-3-(2-methyl-1-propenyl)-, (3-phenoxyphenyl) methyl ester, (1R)
IUPAC Name:
Cyclopropanecarboxylic acid, 2,2-dimethyl-3-(2-methyl-1-propenyl)-, (3-phenoxyphenyl) methyl ester, (1R)
Constituent 3
Reference substance name:
188023-86-1
Cas Number:
188023-86-1
IUPAC Name:
188023-86-1
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): d-Phenothrin
- Physical state: yellow to brown transparent viscous liquid
- Purity test date: 25 August 2005
- Lot/batch No.: S5237276801
- Expiration date of the lot/batch: July 2008
- Stability under test conditions: gavage solutions were prepared freshly prior to dosing on all occasions
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Animal Breeding Facility, JRF
- Age at study initiation: 10-11 weeks
- Weight at study initiation: 153-172 g
- Fasting period before study: overnight until 3 h post dosing
- Housing: 3 rats per cage, polypropylene cages, rice husk bedding
- Diet (e.g. ad libitum): rat pellet feed (Amrut brand) ad libitum
- Water (e.g. ad libitum): filtered water ad libitum
- Acclimation period: 6-8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 63-67
- Air changes (per hr): min. 15
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: 2006-03-22 To: 2006-04-07

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
0.5% carboxymethyl cellulose
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: no mortality at 2000 mg/kg bw in a single rat
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3+3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation at 30 min, 1, 2, 3, 4, 6 h after dosing on the day of dosing, Subsequently, rats were observed twice per day. Animals were weighed weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
LD50 cut-off was determined using the flowchart provided by OECD TG 423

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
None
Body weight:
Normal weight gain was recorded.
Gross pathology:
No external or visceral abnormalities.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No mortality or clinical signs for toxicity was oberseved in female rats treted with single doses of 2000 mg/kg bw. Thus, the test material is not classified for acute oral toxicity according to the criteria of Regulation 1272/2008.
Executive summary:

This study was performed to assess the acute oral toxicity of d-Phenothrin in Wistar rats. The method followed was as per the guidelines of OECD NO 423 (December 2001).

Wistar rats, fasted overnight, were dosed with d-Phenothrin in 0.5% (w/v) carboxymethl cellulose as single oral gavage, using intubation cannula. The food was withheld until 3 hours post dosing. The first set (set I) of three female rats was given a single dose of 2000 mg d-Phenothrin/kg body weight. No mortality was observed at this dose level; hence the second set of 3 female rats (set II) was administered with same dose of 2000 mg d-Phenothrin/kg body weight. As no mortality was observed at this dose level, further testing was not required. No clinical symptoms or mortalities were observed in the rats treated with 2000 mg d-Phenothrin/kg body weight. The rats sacrificed at termination did not reveal any lesion of pathological significance.

The acute oral median lethal dose LD50 (cut off value) of d-Phenothrin in Wistar rats was found to be 5000 mg/kg body weight.