(1S,3S)-3-((Z)-2-chloro-3,3,3-trifluoroprop-1-en-1-yl)-2,2-dimethylcyclopropane-carboxylic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

Adopted 22 March 1996

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

Of commission Directive 96/54/EC

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

1998

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

(1S,3S)-3-((Z)-2-chloro-3,3,3-trifluoroprop-1-en-1-yl)-2,2-dimethylcyclopropane-carboxylic acid

Cas Number:

76023-99-9

Molecular formula:

C9 H10 Cl F3 O2

IUPAC Name:

(1S,3S)-3-((Z)-2-chloro-3,3,3-trifluoroprop-1-en-1-yl)-2,2-dimethylcyclopropane-carboxylic acid

Test material form:

solid

Specific details on test material used for the study:

Batch no. 554-MC-67-5

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent , United Kingdom
- Age at study initiation:approx. 8-12 weeks old
- Weight at study initiation: males: 242– 256 g, females: 200 – 237 g

- Housing: Groups of three by sex in solid-floor polypropylene cages furnished with woodflakes
- Diet and water: Free access to food (Rat and Mouse Expanded Diet No. 1, Speciel Diets Services Limited, UK) and drinking water except for an overnight fast before dosing and approx. 3-4 hours after dosing
- Acclimation period:at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23 °C
- Humidity (%): 49-70 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

Dose volume 10 ml/kg bw administered by gavage.

Doses:

2000 mg/kg bw; 200 mg/kg bw

No. of animals per sex per dose:

2000 mg/kg bw: 3 female rats
200 mg/kg bw: 3 female + 3 male rats

Control animals:

no

Details on study design:

2000 mg/kg bw was selected as starting dose based on available information and administered to three fasted female rats. Based on the results from this dose level further groups of fasted animals were treated with a dose level of 200 mg/kg bw. Dosing was performed sequentially.
Animals were observed ½, 1, 2 and 4 hours after dosing and then once daily for up to 14 days.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 500 - < 1 000 mg/kg bw

Based on:

test mat.

Mortality:

Two animals treated with 2000 mg/kg were found dead within two hours of dosing.

Clinical signs:

other: Signs of systematic toxicity noted in animals treated with 2000 mg/kg were hunched posture, lethargy, ataxia, decreased respiratory rate, laboured respiration, pilo-erection, prostration, clonic convulsions and splayed gait, lasting up to five daty after

Gross pathology:

Abnormalities noted at necroscopy of animals that died during the study were haemorrhagic lungs, dark liver and dark kidneys.
No abnormalities were noted at necrospopy of animals killed at the end of the study.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

LD50 (rat, oral): 500-1000 mg/kg bodyweight