Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
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:
-Principle of the test: The acute dermal toxicity potential of the m-ABTF was evaluated on white mice
- Short description of test conditions: 2/3 of the animal’s tail was submerged into the substance for various periods of exposure (1-8 hours).
- Parameters analysed / observed: Skin restorative effect was assessed based on the mortality outcome, calculating the time of death of 50% of the studied animals.
GLP compliance:
no
Test type:
other: Not stated
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): NA
- Preliminary purification step (if any): Not stated
- Final concentration of a dissolved solid, stock liquid or gel: undiluted
- Final preparation of a solid (e.g. stock crystals ground to fine powder using a mortar and pestle): NA

Test animals

Species:
mouse
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 (if applicable): Not stated
- Source: Not stated
- Females (if applicable) nulliparous and non-pregnant:Not stated
- Rationale for use of males (if applicable): 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 (e.g. ad libitum): Not stated
- Water (e.g. ad libitum):Not stated
- Acclimation period:Not stated
- Microbiological status when known: 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

Type of coverage:
other: 2/3 of the tail was submerged in the substance
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 2/3 of the tail
- % coverage: Not stated
- Type of wrap if used: NA

REMOVAL OF TEST SUBSTANCE
- Washing (if done): NA
- Time after start of exposure: Not stated

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Not stated
- Concentration (if solution): Pure - concentration not specified
- Constant volume or concentration used: Not stated
- For solids, paste formed: yNA

VEHICLE
- Amount(s) applied (volume or weight with unit): NA
- Concentration (if solution): NA
- Lot/batch no. (if required): NA
- Purity: NA
Duration of exposure:
Between 1-8 hours
Doses:
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: The skin restorative effect was examined.
Statistics:
Not stated

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
other: TL50
Effect level:
6 other: hours
Based on:
test mat.
Remarks on result:
other: TL = time of death of 50% of animals
Mortality:
Mortality was noted with limited information available to comment further
Clinical signs:
Not stated
Body weight:

Not stated
Gross pathology:
Not stated
Other findings:
In surviving animals, the tail was subjected to dry necrosis with it falling off on day 3-4.

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 TL50 of 6 hours.
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 tails of mice were submerged into the test substance m-Aminobenzotrifluoride (m-ABTF, a synonym for alpha,alpha,alpha-trifluoro-m-toluidine) in a single exposure for a period of 1 - 8 hours. The effect on skin of the tail was noted with animal dealth and survival recoreded. The TL50 was determined to be 6 hours with tails of surviving animals showing dry necrosis with sections of exposed tail falling off on day 3-4. 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.