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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:
key study
Study period:
10.05.1996 to 28.07.2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EPA OTS 798.1150 (Acute inhalation toxicity)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Inc., 9801 Shaver Road, Portage, MI 49081
- Age at study initiation: 'young'
- Weight at study initiation: 232-245 g
- Fasting period before study: No
- Housing: Individual suspended wire-mesh cages
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: minimum seven days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.6-22.2
- Humidity (%): 32-72
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 23.05.1996 To: 06.06.1996

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure chamber volume: 500 l glass and stainless steel exposure chamber
- Method of holding animals in test chamber: Individual cages
- Source and rate of air: Flow rate was 0.025 ml/min
- Method of conditioning air: No data
- Treatment of exhaust air: No data
- Temperature, humidity, pressure in air chamber: No data

TEST ATMOSPHERE
- Brief description of analytical method used: The nominal exposure concentration was calculated as the ratio of the total amount of test substance used during the exposure divided by the total volume of air passed through the chamber during the exposure. Since the saturated vapour concentration was not known precisely, it was decided to measure the exposure atmosphere using a total hydrocarbon analyser (THCA), and then on the following day prepare gas bag calibration standards that bracketed the instrument response obtained during the exposure. The actual concentrations were then to be calculated from the resulting standard curve.
- Samples taken from breathing zone: No data
Analytical verification of test atmosphere concentrations:
yes
Remarks:
using a total hydrocarbon analyser
Duration of exposure:
4 h
Concentrations:
Estimated to be less than 22 ppm.
No. of animals per sex per dose:
Five
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Rats were observed during the exposure and one hour after removal from the exposure chamber on day 0, and twice daily thereafter. Clinical observations were made upon removal from exposure on day 0 and once daily thereafter. Body weights were obtained immediately prior to exposure on day 0 and on days 3, 7 and 14.
- Necropsy of survivors performed: yes, all animals underwent a gross necropsy. The major organ systems of the cranial, thoracic and abdominal cavities were examined for all animals.
Statistics:
None required.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 22 ppm
Based on:
test mat.
Exp. duration:
4 h
Mortality:
There were no deaths.
Clinical signs:
other: During the exposure, the only clinical finding was hyperactivity noted in one female. Following exposure there were no clinical findings.
Body weight:
There were no effects on body weight.
Gross pathology:
At necropsy, only two abnormalities were noted. One female exhibited dark red lungs and one male exhibited a white area on the spleen. All other animals were considered normal.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In an acute inhalation study conducted using a protocol that was similar to OECD 403, and in compliance with GLP (reliability score 1) the LC50 was at least 22 ppm (the highest dose tested) in rats. The were no deaths and no significant clinical effects, effects on bodyweight or gross necropsy findings.