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Administrative data

Description of key information

Weight of evidence approach for acute inhalation toxicity:

LC50 (4h, rats) > 49500 ppm v/v (i.e. > 379 mg/L air). (Snee 1970)

LC50 (4h, rats) > 45000 ppm v/v (i.e. > 348 mg/L air), read-across from 1,1,1-trichloro-2,2,2-trifluoroethane (Snee 1970)

LC50 (2h, rats) > 110000 ppm v/v, read-across from 1,1,1-trichloro-2,2,2-trifluoroethane (Desoille 1968)

For this endpoint Snee 1970 and Desoille 1968 are available, both with very limited information on study parameters.

Nevertheless both studies report inhalation toxicity only at extremely high concentrations (Snee for 1,1,1-trichloro-2,2,2-trifluoroethane (R113a) and 1,1,2-trichloro-1,2,2-trifluoroethane (R113; read-across) and Desoille 1968 for 1,1,2-trichloro-1,2,2-trifluoroethane (R113; read-across)).

Therefore it can be concluded that acute inhalation toxicity of 1,1,1 occurs only at levels 1,1,1-trichloro-2,2,2-trifluoroethane (R113A) at levels far above the threshold values for medern OECD Guideline studies.

Acute oral toxicity (indicative data): LD50 (rat) >> 232 mg/kg bw LD50 (rat) = 43000 mg/kg bw, read-across from 1,1,2-trichloro-1,2,2-trifluoroethane

This information is only of indicative nature as the endpoint of oral toxicity was waived based on the availability of acute inhalation toxicity data. Due to the volatility of the substance, inhalation is the most likely route of exposure.

Key value for chemical safety assessment

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1970
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Reason / purpose for cross-reference:
reference to same study
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
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
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 the 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: 49500 ppm v/v, equivalent to 379 mg/L
No. of animals per sex per dose:
6 male rats were treated
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
Sex:
male
Dose descriptor:
LC0
Effect level:
>= 379 mg/L air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Sex:
male
Dose descriptor:
LC50
Effect level:
> 379 mg/L air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Mortality:
None of the 6 rats died during the study.
Clinical signs:
other: hyperactivity, irregular respiration, pallor, uncoordinated movements, "piano-players" syndrome
Body weight:
Normal body weight gain was observed throughout the study.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute inhalation toxicity of 1,1,1-trichlorotrifluoroethane 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. None of the six animals died. LC50 (4h, rats) of 1,1,1-trichlorotrifluoroethane was greater than the analytical concentration of 49500 ppm v/v (equivalent to 379 mg/L air).
Executive summary:

The acute inhalation toxicity of 1,1,1-trichlorotrifluoroethane 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. None of the six animals died. LC50 (4h, rats) of 1,1,1-trichlorotrifluoroethane was greater than the analytical concentration of 49500 ppm v/v (equivalent to 379 mg/L air).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
0.379 mg/m³
Quality of whole database:
acceptable

Additional information

For 1,1,1-trichloro-2,2,2-trifluoroethane (liquid, high vapour pressure, volatile) the inhalation route is more relevant for human exposure than the oral route.

The acute inhalation toxicity was assessed in tests with rats with 1,1,1-trichloro-2,2,2-trifluoroethane and with 1,1,2-trichloro-1,2,2-trifluoroethane (read-across):

LC50 (4h, rats) > 49500 ppm v/v (i.e. > 379 mg/L air).

LC50 (4h, rats) > 45000 ppm v/v (i.e. > 348 mg/L air), read-across

LC50 (2h, rats) > 110000 ppm v/v, read-across

All values show a low acute inhalation toxicity. The first value obtained from the test with 1,1,1-trichloro-2,2,2-trifluoroethane is selected as the key parameter and carried forward for risk assessment, and classification and labelling.

The acute inhalation toxicity of the target chemical 1,1,1-trichloro-2,2,2-trifluoroethane is partly 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).

In accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.2, the available data for acute inhalation toxicity is considered to be adequate for the purposes of risk assessment, and classification and labelling, based on the weight-of-evidence.

For the acute oral toxicity no adequate data are available for its definitive assessment. However the available data indicate a low toxicity (i.e. LD50 (oral) = 43000 mg/kg bw and LD50 (oral) >> 232 mg/kg bw.). One result originates from read read-across: the analogue approach is justified in Section 13 (Assessment Reports_Read-Across, in attachment CAS_354-58-5_Read-Across.pdf).

Justification for classification or non-classification

The substance shows a low acute inhalation toxicity. As a result the substance does not meet the criteria for classification (acute toxicity, inhalation route) under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC, Annex VI, 3.2.

The substance shows a low acute inhalation toxicity. As a result the substance does not meet the criteria for classification (acute toxicity, inhalation route) under Regulation (EC) 1272/2008, Annex I, Part 3, 3.1.2.