Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study performed before test guidelines and GLP principles were in place. No details given on the test animals used; Analytical data of substance concentration not included; no cage side observations/ body weight recordings after exposure; no necropsy on dead animals; no details on housing after exposure. No details on test substance (Lot/Batch number; purity). Due to the physical properties of the substance it is not possible Because of the characteristics of the material, it is difficult to generating aerosol.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
Analytical data of substance concentration not included; no cage side observations/ body weight recordings after exposure; no necropsy performed.
GLP compliance:
no
Remarks:
Study was conducted before GLP principles were in force.
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Substance type: colourless solid
- Analytical purity: Not described
- Purity test date: Not described
- Lot/batch No.: Not described
- Melting temperature: 57°C

Test animals

Species:
rat
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: not described
- Age at study initiation: not described
- Weight at study initiation: not described
- Fasting period before study: not described
- Housing: not described
- Diet: stock diet ad libitum
- Water: tap water ad libitum
- Acclimation period: not described

ENVIRONMENTAL CONDITIONS
No details given

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: stainless steel /glass exposure chamber
- Exposure chamber volume: 1.5m3
- Method of holding animals in test chamber: individually kept in wire screen cages
- Airflow: 2.16 m3/h
- Method of conditioning air: not described
- System of generating aerosols: substance was dispersed at 90°C by stainless steel/ glass aerodynamic nozzle nebulizer to fine mist
- Method of particle size determination: by Cascade Impactor
- Treatment of exhaust air: not described
- Temperature, humidity, pressure in air chamber: not described

TEST ATMOSPHERE
- Brief description of analytical method used: Twenty-five liter samples of the atmosphere was drawn through a Cambridge glassfiber filter. Filter was weighed before an dafter the sampling to determine concentration
- Samples taken from breathing zone: yes
- Particle size distribution: 1.5 - 8.3 µm (3-5.9 µm (95%))

Analytical verification of test atmosphere concentrations:
yes
Remarks:
gravimetrically
Duration of exposure:
4 h
Concentrations:
2.67 mg/l air
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily, no weighing
- Necropsy of survivors performed: no
- No other examinations performed

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
>= 2.67 mg/L air
Based on:
test mat.
Remarks on result:
other: maximum attainable concentration
Mortality:
None of the animals died during the exposure period, but three males died within 48 hours after termination of the exposure.
Clinical signs:
The rats could not be observed during exposure due to invisibility caused by the dense mist. No observations after exposure described.

Applicant's summary and conclusion

Interpretation of results:
sligthly toxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an inhalation toxicity study with rats in accordance with the current OECD guideline, the 4-hour LC50 was found to be higher than 2.67 mg/l of air. At the highest attainable concentration, only three out of ten animals died and thus the substance does not have to be classified for inhalation toxicity according to CLP Regulation (EC) 1272/2008.
Executive summary:

An inhalation toxicity study was performed with 5 male and 5 female rats in accordance with the current OECD guideline. The rats were exposed whole body to the substance by aerosols at the maximal attainable concentration. None of the animals died during the exposure period, but three males died within 48 hours after termination of the exposure. It was concluded that the 4-hour LC50 was higher than 2.67 mg/l of air. Since the LC50 was found to be higher than the highest attainable concentration, the substance does not have to be classified for inhalation toxicity according to CLP Regulation (EC) 1272/2008.