3'-(trifluoromethyl)acetophenone

Endpoint summary

Description of key information

Acute toxicity: oral

Groups of 5 male and 5 female rats were administered a single dose of the undiluted test substance by gavage at a dose level of 2000 mg/kg, followed by a 14-day post-treatment observation period. There was no mortality. Hypoactivity, piloerection and hunched posture were seen in all animals on the treatment day. All animals appeared normal by day 1 after treatment. Body weights were not affected by treatment. Necropsy examinations revealed no observable abnormalities. Therefore the LD50 in rats of both sexes is > 2000 mg/kg body weight.

Acute toxicity: inhalation

Groups of five male and five female Wistar rats were exposed by nose only, flow past inhalation to the aerosolized test article at a mean concentration of 6.913 mg/l for 4 hours. There were no deaths. The principal clinical signs observed wer the findings of ruffled fur, decreased spontaneous activity and uncoordinated movement/gait. All clinical signs disappeared within four days after the exposure. There were no macroscopical pathology findings.

Acute toxicity: dermal

Groups of 5 male and 5 female Wistar rats were administered a single dose of the test item by dermal application at a dose level of 2000 mg/kg for 24 hours under semiocclusive conditions, followed by a 14-day post-treatment observation period. There was no mortality in the study. Therefore, the acute dermal LD50 value was determined to be > 2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 1998

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

1992

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1987

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

- Stability under test conditions: no information available
- Solubility and stability of the test substance in the solvent/vehicle: no information available
- Treatment of test material prior to testing: no information available
- Final dilution of a dissolved solid, stock liquid or gel: 5999 mg test article with vehicle ad 30 ml (no further information (e.g. on correction factor) available

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: BRL Biological Research Laboratories Ltd., Wölferstrasse 4, 4414 Füllinsdorf/Switzerland
- Age at study initiation: ca. 7-11 weeks
- Weight at study initiation: approx. 154-191 g
- Housing: Macrolon Type 4 cages; 5 same-sex animals per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): ca. 50 +/- 20
- Air changes (per hr): 13-14
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

other: 0.5% (w/v) carboxymethylcellulose in 0.1% (w/v) aqueous polysorbate 80

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 5999 mg test article with vehicle ad 30 ml
- Volume applied: 10 ml/kg

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 male and 5 female

Control animals:

no

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no mortality

Clinical signs:

other: Hypoactivity, piloerection and hunched posture were seen in all animals on the treatment day. All animals appeared normal by day 1 after treatment.

Gross pathology:

Necropsy examinations revealed no observable abnormalities.

Interpretation of results:

GHS criteria not met

Executive summary:

Groups of 5 male and 5 female rats were administered a single dose of the formulated test substance by gavage at a dose level of 2000 mg/kg, followed by a 14-day post-treatment observation period. There was no mortality. Hypoactivity, piloerection and hunched posture were seen in all animals on the treatment day. All animals appeared normal by day 1 after treatment. Body weights were not affected by treatment. Necropsy examinations revealed no observable abnormalities. Therefore the LD50 in rats of both sexes is > 2000 mg/kg body weight.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

Only one study available

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

other information

Study period:

July - September 1998

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

EU Method B.2 (Acute Toxicity (Inhalation))

Version / remarks:

1992

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Version / remarks:

1981

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1300 (Acute inhalation toxicity)

Version / remarks:

1996 ("Public Draft")

GLP compliance:

yes (incl. QA statement)

Test type:

fixed concentration procedure

Limit test:

yes

Specific details on test material used for the study:

- Stability under test conditions: Considered to be stable
- Preparation of test articel: The test article was used as supplied by the Sponsor. The test aerosol was generated in ambient conditions using a nebuliser connected to a syringe pump.

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: RCC Ltd., Biotechnology & Animal Breeding Division, Wölferstrasse 4, 4414 Füllinsdorf/Switzerland
- Age at study initiation: ca. 8-10 weeks
- Weight at study initiation: approx. 193-227 g
- Housing: Macrolon Type 4 cages; 5 same-sex animals per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1
- Humidity (%): between 50 -80
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Remarks:

flow-past exposure

Vehicle:

air

Remark on MMAD/GSD:

Attempts to measure particle size during the exposure produced faulty and unrepresentative results, because of evaporation of the test article, and consequently condensation inside the impactor used for measuring particle size. Therefore particle size data and a mean mass aerodynamic diameter (MMAD) were not reported.

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

target concentration 5 mg/l air
Achieved concentrations:
- Nominal: 9.217 mg/l air
- Gravimetric: 5.287 mg/l air
- Analytical: 6.913 mg/l air

No. of animals per sex per dose:

5 male, 5 female

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

Statistics:

The LOGIT-Model was not used as only one group was exposed and there were no deaths.

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 6.913 mg/L air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: analytical mean value

Remarks:

with a standard deviation of +- 0.472 mg/l air

Mortality:

no deaths occured

Clinical signs:

other: The principal clinical signs observed were the findings of ruffled fur, decreased spontaneous activity and uncoordinated movements/gait. From the nature and severity of these clinical signs, systemic exposure of the animals to the test article was conclud

Body weight:

Body weights were not affected in male animals. A slight, transient retardation in mean body weight gain of female animals from test day 1 (prior to exposure) to test day 4 may have been treatment-related.

Gross pathology:

There were no macroscopical pathology findings.

Interpretation of results:

GHS criteria not met

Conclusions:

The LC 50 of the test item was estimated to be greater than 6.913 mg/l air (analytical mean value), as no deaths occured.

Executive summary:

Groups of five male and five female Wistar rats were exposed by nose only, flow past inhalation to the aerosolized test article at a mean concentration of 6.913 mg/l for 4 hours. There were no deaths. The principal clinical signs observed wer the findings of ruffled fur, decreased spontaneous activity and uncoordinated movement/gait. All clinical signs disappeared within four days after the exposure. There were no macroscopical pathology findings.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating conc.

Value:

6 913 mg/m³ air

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

other information

Study period:

August 1998

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

1992

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1987

GLP compliance:

yes (incl. QA statement)

Limit test:

yes

Species:

rat

Strain:

other: HanIbm:WIST

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: RCC Ltd., Biotechnology & Animal Breeding Division, Wölferstrasse 4, 4414 Füllinsdorf/Switzerland
- Age at study initiation: ca. 8-12 weeks
- Weight at study initiation: approx. 213-240 g
- Housing: individual (Macrolon Typ 3 cages)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): between 50 +/- 20
- Air changes (per hr): 13-14
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Vehicle:

other: 0.5% (w/v) carboxymethylcellulose in 0.1% (w/v) aqueous polysorbate 80

Details on dermal exposure:

TEST SITE
- Area of exposure: 6 x 6 cm
- % coverage: 10 of body surface
- Type of wrap if used: Isocomfort self-adhesive wrap

REMOVAL OF TEST SUBSTANCE
- Washing: with lukewarm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied: 400 mg per 100 g bw
- Concentration (if solution): 5011 mg with 5000 mg vehicle

Duration of exposure:

14-day post-treatment observation period

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females rats

Control animals:

no

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No

Clinical signs:

other: No remarkable clinical observations.

Gross pathology:

No observable abnormalities.

Other findings:

No remarkable findings at the application site.

Interpretation of results:

GHS criteria not met

Executive summary:

Groups of 5 male and 5 female Wistar rats were administered a single dose of the test item by dermal application at a dose level of 2000 mg/kg for 24 hours under semiocclusive conditions, followed by a 14-day post-treatment observation period. There was no mortality in the study. Therefore, the acute dermal LD50 value was determined to be > 2000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Justification for classification or non-classification

Based on the study results for acute toxicity (oral, inhalation, dermal) no classification according to Regulation (EC) No. 1272/2008 (CLP), ANNEX I, is warranted.