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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.