α,α,α-trifluoro-m-toluidine

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

other: Published Paper

Adequacy of study:

disregarded due to major methodological deficiencies

Study period:

Not stated

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Remarks:

The literature paper does not provide sufficient information on the study

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1968

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

No guideline indicated with no information available

GLP compliance:

no

Test type:

other: Not indicated

Limit test:

no

Test material

Test material information

Test material form:

liquid

Details on test material:

Molecular weight: 161.13 g/mol
pH 6-7

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: Not stated
- Purity, including information on contaminants, isomers, etc.: Not stated

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Not stated
- Stability and homogeneity of the test material in the vehicle/solvent under test conditions (e.g. in the exposure medium) and during storage: Not stated
- Stability in the medium, i.e. sensitivity of the test material to hydrolysis and/or photolysis: Not stated
- Solubility and stability of the test material in the solvent/vehicle and the exposure medium: Not stated
- Reactivity of the test material with the incubation material used (e.g. plastic ware): Not stated

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing (e.g. warming, grinding): Transformation to aerosol - method not stated
- Preliminary purification step (if any): Not stated
- Final concentration of a dissolved solid, stock liquid or gel: Not stated
- Final preparation of a solid: NA

FORM AS APPLIED IN THE TEST (if different from that of starting material)
- Specify the relevant form characteristics if different from those in the starting material, such as state of aggregation, shape of particles or particle size distribution: The test material is used in aerosol form, no other details are provided.

Test animals

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Rationale for alternative/additional species to rat: Not stated
- Source: Not stated
- Females (if applicable) nulliparous and non-pregnant: Not stated
- Rationale for use of males: Not stated
- Age at study initiation: Not stated
- Weight at study initiation: Not stated
- Fasting period before study: Not stated
- Housing: Not stated
- Historical data: Not stated
- Diet : Not stated
- Water: Not stated
- Acclimation period: Not stated
- Microbiological status: Not stated
- Method of randomisation in assigning animals to test and control groups: Not stated

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not stated
- Humidity (%): Not stated
- Air changes (per hr): Not stated
- Photoperiod (hrs dark / hrs light): Not stated

Administration / exposure

Route of administration:

inhalation

Type of inhalation exposure:

not specified

Vehicle:

not specified

Remark on MMAD/GSD:

Not stated

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Not stated
- Exposure chamber volume: Not stated
- Method of holding animals in test chamber: Not stated
- Source and rate of air (airflow): Not stated
- Method of conditioning air: Not stated
- System of generating particulates/aerosols: Not stated
- Method of particle size determination: Not stated
- Treatment of exhaust air: Not stated
- Temperature, humidity, pressure in air chamber: Temperature 28˚C

TEST ATMOSPHERE
- Brief description of analytical method and equipment used: Not stated
- Samples taken from breathing zone: Not stated
- Time needed for equilibrium of exposure concentration before animal exposure: Not stated

VEHICLE
- Composition of vehicle (if applicable): Not stated
- Concentration of test material in vehicle (if applicable): Not stated
- Justification of choice of vehicle: Not stated
- Lot/batch no. (if required): Not stated
- Purity: Not stated

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: Not stated
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): Not stated

CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration: Not stated

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

4 h

Remarks on duration:

Limited information available

Concentrations:

Not stated

No. of animals per sex per dose:

Not stated

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: Not stated
- Frequency of observations and weighing: Not stated
- Necropsy of survivors performed: Not stated
- Clinical signs including body weight: Not stated
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: Not stated

Statistics:

Litchfield and Wilcoxon method modified by Rot

Results and discussion

Effect levels

Sex:

not specified

Dose descriptor:

LC50

Remarks:

The LC50 is indicated as concentration in mg/L and correlation CL54/CL16. In addition, the ratio of possible inhalation poisoning for m-ABTF is reported by the authors as 11.9. (reported in the source paper as CL50)

Effect level:

0.44 other: mg/L and correlation CL54/CL16

Based on:

not specified

Mortality:

Not stated

Clinical signs:

other: Not stated

Body weight:

Not stated

Gross pathology:

Not Stated

Other findings:

Not stated

Any other information on results incl. tables

Table 2: m-ABTF toxicuty at a single inhalation dose 

Toxicity parameter	Animal species	Concentration in mg/l and correlation CL54/CL16
CL16	Rats	0.38
CL50	Rats	0.44
CL84	Rats	0.53
CL16	Rats	1.38

The above table indicate the LC values folllowing the inhalation of m-ABTF. The table indicates CL values which is due to the paper initially published in the Russian language where these abbreviations were not translated. The CL₁₆ and CL₈₄ are values at which are 1 standard deviation either side of the mean value. 

 

 

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

Under the limited conditions of this study outlined in the published paper the test material has an LC50 of 0.44 mg/L.

Executive summary:

The published paper pre-dates the existence of nationally or internationally recognised test methods. No specific details on the test method were provided. The limited information presented indicates that the rats were exposed to m-Aminobenzotrifluoride (m-ABTF, a synonym for alpha,alpha,alpha-trifluoro-m-toluidine) for 4 hours. No clincial signs were noted during the test period. The LC₅₀ indicated as  mg/L and correlation CL54/CL16 was considered to be 0.44. In addition, the ratio of possible inhalation poisoning for m-ABTF is reported by the authors as 11.9 Due to the limited information available on the study conducted this data is not considered reliable for use in the classification of the substance according to CLP Regulation (EC) No 1272/2008.