Trichlorotrifluoroethane

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Study period:

1970

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1970

Report date:

1970

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Six male rats were whole-body exposed to the test item for 4 hours. Analytical determination of test item concentration were performed by gas chromatography. After a 14 d observation period, animals were sacrificed and histopathologic studies were conducted.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,1,2-trichlorotrifluoroethane

EC Number:

200-936-1

EC Name:

1,1,2-trichlorotrifluoroethane

Cas Number:

76-13-1

IUPAC Name:

1,1,2-trichloro-1,2,2-trifluoroethane

Details on test material:

- Molecular formula: C2Cl3F3 (identical to submission substance)
- Molecular weight: 187.376 g/mol (identical to submission substance)
- Smiles notation: ClC(F)(F)C(Cl)(Cl)F (different from submission substance)
- InChl: InChI=1S/C2Cl3F3/c3-1(4,6)2(5,7)8 (different from submission substance)
- Structural formula: see attachment CAS_76-13-1_Structure.png (under "Illustration (picture/graph)")
- Physical state: liquid

Test animals

Species:

rat

Strain:

other: ChR-CD

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 251 - 280 g

Administration / exposure

Route of administration:

inhalation: gas

Type of inhalation exposure:

whole body

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: bell jar
- Exposure chamber volume: 16 liter
- Source and rate of air: houseline air (of test facility)
- System of generating particulates/aerosols: the test item was dispensed into a heated (65°C) stainless steel T-tube using a syringe and diluted with air to give the desired athmospheric concentration.

TEST ATMOSPHERE
- Brief description of analytical method used: GC
- Samples taken from breathing zone: no

Analytical verification of test atmosphere concentrations:

yes

Remarks:

by GC

Duration of exposure:

4 h

Concentrations:

nominal concentration: 50000 ppm v/v
analytical concentration, pure test material: 45500 ppm v/v, equivalent to 348 mg/L
analytical concentration, commercial test material: 49500 ppm v/v, equivalent to 379 mg/L

No. of animals per sex per dose:

6 male rats were treated per group

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LC50

Effect level:

> 348 mg/L air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: pure grade test material

Effect levels 2

Sex:

male

Dose descriptor:

LC50

Effect level:

> 379 mg/L air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: commercial grade test material

Mortality:

In each group (i.e. exposed to pure and commercial test material, respectively), one animal died after 3 h of exposure.

Clinical signs:

other: Clinical sighs observed during exposure were: hyperactivity, irregular respiration, pallor, uncoordinated movements, "piano-players" syndrome

Body weight:

Normal body weight gain was observed throughout the study.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute inhalation toxicity of 1,1,2-trichlorotrifluoroethane (two groups: either with pure or with commercial grade test material) was tested by exposure of six male ChR-CD rats for 4 h. After a 14 d observation period, animals were sacrificed. No histopathologic studies were conducted. Clinical signs during exposure were hyperactivity, irregular respiration, uncoordinated movements, and a symptom reffered as "piano-players syndrome". Normal body weight gain was observed in the post-exposure period. In both groups (i.e. tested with pure and commercial grade test material), one of the six animals died and the LC50 was greater than the analytical concentrations of 45000 and 49000 ppm v/v, respectively.

The acute inhalation toxicity of the target chemical 1,1,1-trichloro-2,2,2-trifluoroethane is determined by read-across from an in vivo test (rats) with the source chemical 1,1,2-trichloro-1,2,2-trifluoroethane. The analogue approach is justified in Section 13 (Assessment Reports_Read-Across, in attachment CAS_354-58-5_Read-Across.pdf). As a consequence the value for LC50 (4 h, rats) of 1,1,1-trichloro-2,2,2-trifluoroethane is greater than 45000 ppm v/v (i.e. >348 mg/L air).

Executive summary:

The acute inhalation toxicity of 1,1,2-trichlorotrifluoroethane (two groups: either with pure or with commercial grade test material) was tested by exposure of six male ChR-CD rats for 4 h. After a 14 d observation period, animals were sacrificed. No histopathologic studies were conducted. Clinical signs during exposure were hyperactivity, irregular respiration, uncoordinated movements, and a symptom reffered as "piano-players syndrome". Normal body weight gain was observed in the post-exposure period. In both groups (i.e. tested with pure and commercial grade test material), one of the six animals died and the LC50 was greater than the analytical concentrations of 45000 and 49000 ppm v/v, respectively.

The acute inhalation toxicity of the target chemical 1,1,1-trichloro-2,2,2-trifluoroethane is determined by read-across from an in vivo test (rats) with the source chemical 1,1,2-trichloro-1,2,2-trifluoroethane. The analogue approach is justified in Section 13 (Assessment Reports_Read-Across, in attachment CAS_354-58-5_Read-Across.pdf). As a consequence the value for LC50 (4 h, rats) of 1,1,1-trichloro-2,2,2-trifluoroethane is greater than 45000 ppm v/v (i.e. >348 mg/L air).