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Acute Toxicity: inhalation

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acute toxicity: inhalation
Type of information:
other: read across form similar substance
Adequacy of study:
key study
Study period:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards and is described in sufficient detail.

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
equivalent or similar to guideline
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
Test type:
standard acute method
Limit test:

Test material

Constituent 1
Reference substance name:
BY29 - similar substance 01
BY29 - similar substance 01

Test animals

Details on test animals or test system and environmental conditions:
TEST ANIMALS- Source: Winkelmann, Borchen, Germany- Weight at study initiation: 160 - 200 g- Housing: 5 animals per cage (macrolon type III cages)- Diet (e.g. ad libitum): ad libitum- Water (e.g. ad libitum): ad libitum- Acclimation period: at least 7 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 19 to 25- Humidity (%): 40 - 60- Air changes (per hr): 15- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
nose/head only
clean air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION- Exposure apparatus: dynamic inhalation apparatus (Kimmerle et al., Arch. Toxicology 30, 115, 1973)- Exposure chamber volume: 40 L (20 L pre-chamber, 20 L exposure chamber)- System of generating particulates/aerosols: dynamic dust generator (Thyssen et al., J. Environmental Pathology and Toxicology, 1, 501, 1978) with a aire pressure of 80-200 kPa, a impulse duration of 0.1 to 0.5 seconds and a time gap between the impulses of 2 to 5 seconds- Method of particle size determination: by using an Anderson cascade impactorTEST ATMOSPHERE- Brief description of analytical method used:the analytical concentration of the test sample in the test atmosphere is calculated from the test sample mass per air volume within the test chamber. The test item mass was determined gravimetrically on membrane filter (B-acetate)- Samples taken from breathing zone: yes
Analytical verification of test atmosphere concentrations:
Duration of exposure:
4 h
147, 292, 483, 733, 2975 mg/m³ (only analytical concentrations reported)
No. of animals per sex per dose:
Control animals:
Details on study design:
- Duration of observation period following administration: 14 days - Frequency of clinical observations: at the day of exposition several times, afterwards twice a day- Frequency of weighing: before exposition and afterwards once per week- Necropsy of survivors performed: yes
LD 50 calculation based on the method of Rosiello et al., 1977 (J. Tox. and Environ. Health 3: 797-809)

Results and discussion

Effect levelsopen allclose all
Dose descriptor:
Effect level:
290 mg/m³ air
Based on:
test mat.
Exp. duration:
4 h
Dose descriptor:
Effect level:
474 mg/m³ air
Based on:
test mat.
Exp. duration:
4 h
see table 1 in "any other information on results incl. tables"
Clinical signs:
other: unspecific behavioral disorders, abnormal breathing, irritation on the visible mucosas of eye and nose. At 483 mg/m³ and above also prone position
Body weight:
no data presented
Gross pathology:
Animals died during the 14 days observation period: liver-like changes of the lung, serous fluid in thorax and trachea, lobular pattern of liver, test item noted in oesophagus and in the gastro-intestinal tract, reddened mucosa of the gastro-intestinal tract, yellowish and bloody mucus in the gut, pale kidneys.Animals sacrificed after the observation period: in some animals the lung was spotted reddish-greyish and with areas of a lobular pattern
Other findings:

Any other information on results incl. tables

Table 1 : Mortality
Analytical concentration (mg/m³ air) Toxicological result* Duration of symptoms Animals found dead Mortality (%)
male rats
147.0 0/10/10 4h - 6d - 0
292.0 2/10/10 4h - 9d 24h 20
483.0 4/10/10 4h - 4d 24h 40
733.0 10/10/10 4h - 6h 4h-24h 100
2975.0 10/10/10 4h - 6h 4h-24h 100
female rats
147.0 1/10/10 4h - 6d 3d 10
292.0 4/10/10 4h - 9d 24h-3d 40
483.0 9/10/10 4h - 4d 4h-24h 90
733.0 10/10/10 4h - 6h 4h-24h 100
2975.0 10/10/10 4h - 6h 4h-24h 100

* first number: number of dead animals, second number: number of animals with symptoms,

third number: number of animals tested

Determination of the mass median diameter (MMAD):

- Mass median diameter: 6.94 µm

- geometric standard deviation: 1.64

- correlation coefficient: 1.00

Respirability (< 5 µm):

a) mass related: 26 % (measured)

b) number related: 50 % (extrapolated)

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category II
Migrated information Criteria used for interpretation of results: EU
In conclusion, the LC50 can be estimated for females with 290 mg/m³ air and for males with 474 mg/m³ air after 4 hours exposure to the test item.
Executive summary:

In an acute inhalation toxicity study equivalent to OECD 403, groups of young male and female Wistar rats (10 per sex/concentration) were exposed by the inhalation route (nose/head only) to the test item for 4 hours at mean concentrations of 147, 292, 483, 733 and 2975 mg/m³ air. Animals then were observed for 14 days. Mortality and distinct clinical signs were observed after exposure to the test substance. Based on the results obtained, the LC50 can be estimated for females with 290 mg/m³ air and for males with 474 mg/m³ air.