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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:
1994-6-27 to 1994-7-11
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
The limit concentration according to the current OECD TG 403 is 20 mg/l (vapour). The limit concentration tested at this study is below the current limit value.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Kingston, Stone Ridge, NY, USA
- Age at study initiation: 49 days
- Weight at study initiation: 159-165 g (m); 107-119 g (f)
- Housing: individual stainless wire mesh cages
- Diet: standard diet ad libitum except during exposure
- Water: drinking water ad libitum
- Acclimation period: 13 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25
- Humidity (%): 9% (during exposure - no details given for observation period)
- Air changes (per hr): 40L/min
- Photoperiod (hrs dark / hrs light): 12h/12 h

IN-LIFE DATES: From: 27 June 1994 To: 11 July 1994

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 apparatus: stainless steel/glass exposure chamber
- Exposure chamber volume: 160 L
- Method of holding animals in test chamber: caged
- Source and rate of air: compressed air system
- System of generating vapour: compressed air through glass vapourization collumn containing glass beads. Additional dilution air sweeps vapour into exposure chamber
- Method of particle size determination: conducted to ensure no aerosol (Andersen 8-stage cascade impactor)
- Temperature, humidity, pressure in air chamber: 25 deg C, 9% humidity

TEST ATMOSPHERE
- Brief description of analytical method used: gas chromatographic method (details in appendix not included with report)
- Samples taken from breathing zone: yes
Analytical verification of test atmosphere concentrations:
yes
Remarks:
GC
Duration of exposure:
4
Concentrations:
nominal 5 mg/l
measured 5.8 mg/l
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 and weighing: body weight days 0, 7, 14; general observations twice daily for 14 days
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5.8 mg/L air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: The recommended limit concentration according to the current guideline is 20 mg/l (vapour).
Mortality:
0/10 deaths
Clinical signs:
other: Rapid respiration and salivation.
Body weight:
All exposed animals gained weight.
Gross pathology:
No treatment-related abnormalities reported.

Any other information on results incl. tables

Table 1: Concentrations, mortality or evident toxicity

Sex

Analytical Conc. (mg/l)

Mortality (No./total)

Overt toxicity

Number with remarkable gross pathology

males

5.8

0/5

Rapid respiration and salivation. No treatment-related effects at 7 and 14 days.

0/5

females

5.8

0/5

Rapid respiration and salivation. No treatment-related effects 14 days.

0/5

 

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The key acute inhalation toxicity study, conducted according to OECD Test Guideline 403 with acceptable restrictions and in compliance with GLP, concluded a 4-hour LC50 value of >5.8 mg/l as vapour (measured) (Dow Corning Corporation, 1994). The restriction of the study was that the limit concentration tested is below the recommended limit concentration according to the most recent guideline (20 mg/l).