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Toxicological information

Acute Toxicity: inhalation

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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 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.

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