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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Qualifier:
according to
Guideline:
EU Method B.2 (Acute Toxicity (Inhalation))
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: rat/CD/Crl:CD
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: males 45 days, females 56 days
- Weight at study initiation: males 204-228 g, females 194-220 g
- Fasting period before study: 16 hours before exposure
- Housing: caged by sex in groups of 2-3 animals/cage
- Diet: feeding was discontinued approx. 16 hours before exposure
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 3°C
- Humidity (%): 55% +/- 15%
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 17.11.2003 To: 02.12.2003

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
nose only
Vehicle:
clean air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: dynamic inhalation chamber (Rotameter, ROTA Apparate- und Maschinenbau, 0-79664 Wehr/Baden)
- Exposure chamber volume: 40 L
- Method of holding animals in test chamber: in pyrex tubes at the edge of the chamber in a radial position.
- Flow rate of air: 900 L/h
- Method of conditioning air: air was taken from the surrounding atmosphere of the laboratory room and filtered using an in-li ne disposable
gas filter
- System of generating particulates/aerosols: rotating brush dust generator (RBG 1000, PALAS GmbH Partikel und Lasermesstechnik, 0-76229
Karlsruhe)
- Method of particle size determination: cascade impactor (MAY, K.R. Aerosol impaetion jets, J.Aerosol Sei..§, 403 (1975), RESEARCH ENGINEERS Ltd, London N1 5RO, UK
- Treatment of exhaust air: passage through appropriate filter
- Temperature, humidity, oxygen content in air chamber: temperature 22°C +/- 3°C, humidity based on the guidelines, recordings of humidity in
the chamber are not made where dust examinations are carried out, oxygen content 21%

TEST ATMOSPHERE
- Brief description of analytical method used: Dust sampies were taken once every hour during the exposure. For that purpose, a SARTORIUS filter
(Minisart SM 17598 0.45 µm) was placed in the purpose-made inlet of the inhalation chamber in such a way that the opening of the filter was close
to the animals' noses. By means of a piece of silicon tubing, the filter was connected to an air-flow meter attached to a pump. The filter was
weighed before and after sampling (accuracy: 10 µg)
- Samples taken from breathing zone: yes

VEHICLE
- Composition of vehicle: clean air
- Concentration of test material in vehicle:
- Purity: filtered using an in-line disposable gas filter)

TEST ATMOSPHERE
- MMAD (Mass median aerodynamic diameter): 2.383 µm
- Geometric mean diameter: 3.3575 µm
- GSD (Geometric st. dev.): 3.629 µm

Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
5.15 +/- 0.10 mg/l
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations for mortality and clinical signs: during and after exposure, daily thereafter
- Frequency of weighing: day 0 (prior to dosing), day 7 and day 14
- Necropsy of survivors performed: yes
- Other examinations performed: gross examination of organs at necropsy, organ weights,

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LC0
Effect level:
> 5.15 mg/L air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5.15 mg/L air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Mortality:
no mortality occurred
Clinical signs:
Particular attention was directed to observation of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma
Body weight:
Individual weights of animals were determined before the exposure and weekly after exposure. Changes in weight were calculated and recorded when survival exceeds one day.
Gross pathology:
Macroscopic post mortem findings: no pathological findings

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
Under the present test conditions, no signs of toxicity were observed at 5.15 ± 0.1 0 mg L-threonine/L air. No mortality occurred. No abnormalities were detected at necropsy. The animals gained the expected weight throughout the study period.