Registration Dossier

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study was conducted according to an appropriate OECD test guideline and in compliance with GLP.

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)
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: Current guidelines set the limit concentration for vapour at 20 mg/l.
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:
other: cannot classify (see Overal Remarks, above)
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
A well reported study, conducted according to generally accepted scientific standards and in accordance with GLP, found no toxicity when male and female rats were exposed for 4 h to a measured atmosphere containing 5.8 mg/l (vapour) of the test material. The LC50 would exceed this value.