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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:
1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Principles of method if other than guideline:
The mean actual exposure concentrations were significantly higher than OECD limit test guideline of 5 mg/l.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

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 Laboratories, Raleigh, NC

- Age at study initiation:Males approximately 8 weeks and females approximately 10 weeks old when exposed.

- Weight at study initiation: 126 - 150 g

- Housing: Individually in stainless steel, wire mesh-bottom cages

- Diet: Purina rodent chow ad libitum except during exposure

- Water: Ad libitum

- Acclimation period: One week

ENVIRONMENTAL CONDITIONS

- Temperature (°C): 22 ± 2

- Humidity (%): 30 - 70

- Air changes (per hr): Not stated

- Photoperiod (12 hrs dark /12 hrs light):

IN-LIFE DATES: From: 15th February 1994 To: 3rd March 1994

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION

- Exposure apparatus: Stainless steel and glass exposure chambers

- Exposure chamber volume: 120 litre

- Method of holding animals in test chamber:

- Source and rate of air: Ambient air; 10-15 air changes per hour (20.4 - 20.5 litres per minute)

- Method of conditioning air: HEPA and charcoal filters

- System of generating particulates/aerosols: Not applicable

- Method of particle size determination: Not applicable

- Treatment of exhaust air: HEPA and charcoal filters then passed through water scrubber

- Temperature, humidity in chamber: 22.9 - 23.9 °C; 52.0 - 61.2% humidity

TEST ATMOSPHERE

- Brief description of analytical method used: Gas chromatography

- Samples taken from breathing zone: Yes

VEHICLE

Not applicable

TEST ATMOSPHERE
- Particle size distribution: Not applicable

- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): Not applicable
Analytical verification of test atmosphere concentrations:
yes
Remarks:
GC
Duration of exposure:
4 h
Concentrations:
11,000; 14,000 and 18,000 (nominal); 10,067; 14,050 and 16,659 ppm (as measured by gas chromatography)
No. of animals per sex per dose:
5/sex/dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight, organ weights, gross pathology
Statistics:
No statistical analysis included.

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
15 956 ppm
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: 95% CL = 14,024-34,045
Sex:
male/female
Dose descriptor:
other: NOEL
Effect level:
10 067 ppm
Based on:
test mat.
Exp. duration:
4 h
Mortality:
See Table 1.

One animal in the mid-dose group was sacrificed for human reasons on Day 2. This was not included in the statistical analysis.
Clinical signs:
other: During the 4-hour exposure, some of the animals exposed to concentrations of 14,050 and 16,659 ppm test material experienced prostration and convulsions. Ataxia was also observed in the high exposure group. The primary clinical sign after the exposure was
Body weight:
No apparent effects on body weight gains were observed.
Gross pathology:
In animals that died, congestion and/or haemorrhage of various lobes of the lung were observed in males and females. Congestion of the lungs was also noted in one female from each of the two higher exposure groups at the final sacrifice of the animals that survived exposure.
Other findings:
- Potential target organs: Lung

- Other observations: Response was generally consistent between males and females.

Any other information on results incl. tables

Table 1: Concentrations, exposure conditions and number of evident toxicity per animals treated

Nominal

Conc. (ppm)

Analytical Conc. (ppm)

Number dead/Number exposed

Males

Females

Combined

11000

10067 

 0/5

0/5 

0/10

 14000

14050

 1/5

 1/5

 2/10

18000

 16659

3/5

3/5

 6/10

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
An acute inhalation LC50 of 15,956 ppm with (95% confidence limits of 14,024-34,045) was determined for male and female rats in an reliable study conducted according to an appropriate test protocol, and in compliance with GLP. This is equivalent to ca. 106 mg/l.