Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
The study was conducted according to the appropriate guideline, but not in compliance with GLP. No information is given on the test material purity, the analytical verification of the test concentration, and the method of generating the vapour or aerosol.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
(1981)
Deviations:
no
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratory
- Weight at study initiation: approximately 230 g
- Fasting period before study: no
- Housing: in satndard stainless steel, wire mesh bottom cages of conventional design during acclimatisation period, and in special stainless steel cages during experiment and subsequent observation period
- Diet: Purina Rodent Chow, ad libitum (except during exposure)
- Water: ad libitum (except during exposure)
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- not specified (under controlled laboratory conditions)

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
whole body
Vehicle:
clean air
Remarks:
(filtered with hepa and charcoal filters)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: stainless steel and glass exposure chamber
- Exposure chamber volume: 450 l
- Method of holding animals in test chamber: in special stainless steel cages
- Source and rate of air: dynamic airflow (16-19 air changes per hour); supplied by a heating, ventilation, and air conditioning system, which filtered the air and controlled temperature and humidity
- System of generating particulates/aerosols: not specified
- Method of particle size determination: no data
- Treatment of exhaust air: filtered by a hepa filter, charcoal filter, and water scrubber
- Temperature, humidity, pressure in air chamber: 69±2°F (19.44-21.67°C), 43±3% humidity

TEST ATMOSPHERE
- Brief description of analytical method used: no data
- Samples taken from breathing zone: no data
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
4 h
Concentrations:
0.6 mg/l target concentration (highest concentration that was able to be generated with the test equipment)
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: frequently during exposure and daily during the week days of the post-exposure period
- Frequency of weighing: after 7 and 14 days
- Necropsy of survivors performed: yes (complete gross pathological examination on all major tissues and organs, with special attention was paid to the lung and trachea)

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 600 mg/m³ air (nominal)
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: highest concentration that was able to be generated with the test equipment
Mortality:
No mortality occurrend throughout the study period.
Clinical signs:
other: No clinical signs were reported.
Body weight:
There was no effect on the body weights observed throughout the study period.
Gross pathology:
There were no apparent abnormalities of major organs and tissues observed at the time of necropsy.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
Conclusions:
The test item was investigated for acute inhalation toxicity in a study conducted according to the OECD test guideline 403. Following 4 h of exposure, there was no toxicity observed in neither males nor females at 600 mg/m³, which was the highest concentration that was able to be generated with the test equipment. Thus, the LC50 value was set at >600 mg/m³.