Cyclopropanecarboxylic acid, 3-[(1Z)-2-chloro-3,3,3-trifluoro-1-propen-1-yl]-2,2-dimethyl-, (1R,3R)-rel-

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1986-10 to 1987-02-24

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

significant methodological deficiencies

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

yes

Remarks:

Limit concentration of 5 mg/L or recommended concentration of 2 mg/L not reached, and no rationale given. Mass median aerodynamic diameter of aerosols >4 micrometer (5.3 and 7.3 micrometer, at lower and higher concentration, respectively).

GLP compliance:

yes

Remarks:

Summary report derived from a study which fulfills the requirements of GLP; not further documented

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

reaction mass of (1R,3R)-3-[(1Z)-2-chloro-3,3,3-trifluoroprop-1-en-1-yl]-2,2-dimethylcyclopropanecarboxylic acid and (1S,3S)-3-[(1Z)-2-chloro-3,3,3-trifluoroprop-1-en-1-yl]-2,2-dimethylcyclopropanecarboxylic acid

EC Number:

614-283-9

Cas Number:

68127-59-3

Molecular formula:

C9H10ClF3O2

IUPAC Name:

reaction mass of (1R,3R)-3-[(1Z)-2-chloro-3,3,3-trifluoroprop-1-en-1-yl]-2,2-dimethylcyclopropanecarboxylic acid and (1S,3S)-3-[(1Z)-2-chloro-3,3,3-trifluoroprop-1-en-1-yl]-2,2-dimethylcyclopropanecarboxylic acid

Details on test material:

- Physical state: finely divided powder
- Colour: white
- Expiration date of the lot/batch: not reported
- Storage condition of test material: not reported

Test animals

Species:

rat

Strain:

other: Alpk:AP

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: not reported
- Age at study initiation, weight at study initiation: not reported
- Fasting period before study: not reported
- Housing, diet, water: not reported
- Acclimation period: not reported

ENVIRONMENTAL CONDITIONS
- not reported

IN-LIFE DATES: From: To: not reported

Administration / exposure

Route of administration:

inhalation: dust

Type of inhalation exposure:

nose only

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus, chamber volume, method of holding animals in test chamber: not reported
- Source and rate of air, conditioning air: not reported
- System of generating particulates/aerosols: Wright's dust feed
- Method of particle size determination: Marple cascade impactor
- Treatment of exhaust air: not reported
- Temperature, humidity, pressure in air chamber: not reported

TEST ATMOSPHERE
- Brief description of analytical method used: 25mm open-faced filters, gravimetric determination likely (since no reference to analytical method is given)
- Samples taken from breathing zone: no data

VEHICLE
- none

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution:
at 0.09 mg/L: 84% inhalable (<= 15 micrometer aerodynamic equivalent diameter AED), 23% respirable (<= 2.5 micrometer AED);
at 1.1 mg/L: 79% inhalable (<= 15 micrometer AED), 12% respirable (<= 2.5 micrometer AED);
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): MMAD at 0.09 mg/L: 5.3 micrometer, at 1.0 mg/L: 7.3 micrometer; GSD not reported
- Rationale for the selection of the starting concentration: none given

Analytical verification of test atmosphere concentrations:

yes

Remarks:

no analytical method reported; probably gravimetric

Duration of exposure:

4 h

Concentrations:

nominal: 0.1 and 1.0 mg/L
analytical: 0.09 +/- 0.01 mg/L and 1.1 +/- 0.1 mg/L

No. of animals per sex per dose:

5 males and 5 females

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: not reported
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights (lungs and liver)

Statistics:

None (no mortalities observed)

Results and discussion

Preliminary study:

None reported

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LC0

Effect level:

>= 1.1 mg/L air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

>= 1.1 mg/L air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: No mortalities observed

Mortality:

None observed

Clinical signs:

other: Animals exposed to the high concentration had test material around their snouts. Stains around the snout, chromodacryorrhea and wet fur during exposure, as well as hunched posture and piloerection immediately following exposure were observed both in the t

Body weight:

No average or individual data are presented in the report. No toxicologically significant effects on body weight or weight gain were observed.

Gross pathology:

No significant macropathological changes were observed in the treated animals.

Other findings:

- Organ weights: At 1.1 mg/L, the liver/body weight ratio was statistically significantly lowered in males, although the reduction was very small (7%, with no associated clinical or post-mortem findings). All other organ weights (absolute and relative) were normal. Neither average nor individual values are tabulated in the report.

Applicant's summary and conclusion

Interpretation of results:

other: not conclusive

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The acute inhalation LC50 of the test substance was estimated to be greater than 1.1 mg/L to male and female rats. Confidence limits could not be calculated. The study report is relevant, but not adequate and reliable for classification and labeling.

Executive summary:

The acute inhalation toxicity of the test material (a powder) was assessed according to a method similar to OECD 403 in groups of five male and five female rats, at analytical aerosol concentrations of 0.1 mg/L and 1.1 mg/L. The test substance aerosols were generated using a Wright’s dust feed, quantified by deposition on 25 mm open-faced filters, and their particle size distribution was assessed with a Marple cascade impactor. The mass median aerodynamic diameters obtained were 5.3 micrometer at 0.1 mg/L, and 7.3 micrometer at 1.1 mg/L. No attempt to reach the aerosol concentration recommended in OECD 403 (2 mg/L) or the limit test condition (5 mg/L) was reported. Mortalities, signs of toxicity, body and organ (lung and liver) weight developments were recorded during 14 days; survivors were examined by necropsy for macroscopic abnormalities.

Mortalities were not observed, so that a statistical calculation of the LC50 could not be performed. The clinical symptoms, stains around the nose, piloerection, and hunched posture, though persisting up to day 15, were considered a mild, non-specific response to exposure. Body and organ weights developed normally, except for a slight but statistically significant decrease (7%) of the relative liver weight in the males of the higher concentration group. No macroscopical abnormalities were detected.

From the absence of mortalities (LC0>1.1 mg/L), the acute inhaltation LC50 > 1.1 mg/L was estimated.