Reaction mass of 3-phenoxybenzyl (1R,3R)-2,2-dimethyl-3-(2-methylprop-1-en-1-yl)cyclopropanecarboxylate and 3-phenoxybenzyl (1R,3S)-2,2-dimethyl-3-(2-methylprop-1-en-1-yl)cyclopropanecarboxylate (4:1)

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Feb - Oct 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP / guideline study wiith no deficiencies

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 403 (Acute Inhalation Toxicity)

Version / remarks:

May 12, 1981

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

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
- Storage condition of test material: room temperature

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/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: m: 230 - 264 g, f: 170 - 216 g
- Fasting period before study: no
- Housing: 5 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: min. 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23
- Humidity (%): 64 - 66
- Air changes (per hr): min. 15
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: 2006-05-24 To: 2006-06-07

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose/head only

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: BIO-TOX
- Exposure chamber volume: 63.5 L
- Method of holding animals in test chamber: exposure tubes
- Source and rate of air: compressed ambient air, 12 - 15 air changes per hour, 15 L/min
- Method of conditioning air: air filter -> moisture separator -> high flow filter -> charcoal filter -> silica gel filter -> air filter with regulator
- System of generating particulates/aerosols: spray atomizer
- Method of particle size determination: seven-stage cascade impactor, gravimetric analysis
- Treatment of exhaust air: passed through NaOH solution and silica gel moisture traps
- Temperature, humidity, pressure in air chamber: 20.9 - 22.4 °C, RH: 44.3 - 48.0%, oxygen: 20.4 - 20.9%

TEST ATMOSPHERE
- Brief description of analytical method used: gravimetric
- Samples taken from breathing zone: yes
- Particle size distribution:
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 3.13 µm / 2.66 µm

Analytical verification of test atmosphere concentrations:

yes

Remarks:

gravimetric

Duration of exposure:

4 h

Concentrations:

Actual concentration: 5.301 mg/L

No. of animals per sex per dose:

10

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: hourly during exposure, twice daily for mortality/morbidity, once daily for clinical signs
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

Not applicable for limit test

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.301 mg/L air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Mortality:

No mortality

Clinical signs:

other: No clinical signs

Body weight:

Body weights of controls and treatment groups were comparable

Gross pathology:

No external or visceral abnormalities

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

At the maximum achievable concentration (5.301 mg/L air) of d-Phenothrin, no mortality was observed. Hence, the acute inhalation median lethal concentration (LC50) of d-Phenothrin was concluded to be greater than 5.301 mg/L air. The test material is not classified for acute inhalation toxicity according to the criteria of Regulation 1272/2008.

Executive summary:

This study was performed to assess the acute inhalation toxicity (LC50) of d-Phenothrin in Wistar rats. The method followed was as per the guideline of OECD N° 403 (May 1981).

Two groups of rats, each consisting of five males and five females were used for the study. Rats from Group I were exposed to air only and served as the control group. Rats from Group II were exposed to the maximum achievable breathing zone concentration (5.301 mg/L air) of d-Phenothrin. Rats from either group were exposed for 4 hours followed by observation for a period of 14 days. All the rats from the control and the treatment group appeared normal throughout the experiment period. The mean body weight of rats belonging to the treatment group was comparable to that of the control group. The rats, sacrificed terminally from the control and the treatment group did not reveal any pathological abnormality.

At the maximum achievable breathing zone concentration (5.301 mg/L air) of d-Phenothrin, no mortality was observed. Hence, the acute inhalation median lethal concentration (LC50) of d-Phenothrin was concluded to be greater than 5.301 mg/L air.