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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1988-08-11 to 1989-02-22
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
The restrictions were that the test concentration was not the maximum concentration for vapours and no analythical verification of the test concentration was performed.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
1981
Deviations:
yes
Remarks:
The study does not meet current guideline requirements.
GLP compliance:
yes
Test type:
traditional method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Basic Material Business, BB058016

FORM AS APPLIED IN THE TEST (if different from that of starting material): vapour

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, USA
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: no data
- Weight at study initiation: 175 - 200 g
- Fasting period before study: no data
- Housing: In stainless steel, wire mesh bottomed cages of convensional design
- Diet: ad libitum except during the exposure period
- Water: ad libitum except during the exposure period
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30 - 50 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
air
Remark on MMAD/GSD:
No data
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Stainless steel and glass chamber
- Exposure chamber volume: 450-liter
- Method of holding animals in test chamber: no data
- Source and rate of air: Air passed through a J-tube and rate of the airflow was monitored by Magnehelic gauges. A glass J-tube with a low flow FMI Lab pump was used to introduce test material into the chamber. Filtered laboratory air passed through the J-tube. The air/ vapour mixture entered the top of the chamber where it was diluted with room air. Heating tape was used to heat the air which passed through the J-tube, and glass beads were used to help vaporise the test material.
- Method of conditioning air: Matheson 462 cartridge filter
- Treatment of exhaust air: the exhaust air was filtered (hepa and carbon), cleaned with a water cyclone, then exhausted from the roof of the building.
- Temperature, humidity, pressure in air chamber: Chamber temperature and relative humidity were monitored with Cole-Primer Model No. 3310-40 (certified) temperature and humidity gauges.
- A glass J-tube with a low flow FMI Lab pump was used to introduce test material into the chamber. Filtered laboratory air passed through the J-tube. The air/ vapour mixture entered the top of the chamber where it was diluted with room air. Heating tape was used to heat the air which passed through the J-tube, and glass beads were used to help vaporise the test material.

TEST ATMOSPHERE
- Brief description of analytical method used: no data
- Samples taken from breathing zone: no


TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: no data
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): no data

Analytical verification of test atmosphere concentrations:
not specified
Remarks:
The calculated nominal concentration was 4.9 mg/L. The actual exposure concentration was slightly less than the calculated value due to condensation of the test material.
Duration of exposure:
4 h
Remarks on duration:
The exposure period lasted 4 hours after chamber equilibration.
Concentrations:
5.0 mg/L
No. of animals per sex per dose:
5 males and 5 females
Control animals:
yes
Remarks:
The control group was exposed to filtered room air.
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed once a day during weekdays. Individual animal body weights were measured prior to the treatment, then on days 7 and 14 after exposure. - Necropsy of survivors performed: no data
- Other examinations performed: clinical signs and body weight
Statistics:
Not used

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
>= 4.9 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
No mortality occurred during the 14-day study period.
Clinical signs:
No clinical signs of toxicity were observed in any of the test animals.
Body weight:
No test-materal related effects on body weights.
Gross pathology:
No data.
Other findings:
No other findings were reported.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In the acute inhalation toxicity study, conducted according to a former version of OECD test guideline, and in compliance with GLP, no LC50 value was reported due to lack of toxic effect observed in any of the test animals.