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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:
1991-08-19 to 1991-09-23
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
adopted: 1981-02-02
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Versuchstierzucht Winkelmann, Borchen, Kreis Paderborn, Germany
- Age at study initiation: 2 to 3 months
- Weight at study initiation: 170 - 210 g
- Housing: 5 animals per cage (Makrolon type III)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 °C +- 2
- Humidity (%): ca. 50 %
- Air changes (per hr): ca. 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose/head only
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: inhalation chamber (TSE Labortechnik, Bad Homburg)
- Exposure chamber volume: 20 L
- Method of conditioning air: VIA-Drucklufttrockner
- System of generating particulates/aerosols: Wright-Dust-Feeder + self constructed metal cyclone as particle precipitator (used at higher doses)
- Method of particle size determination: Berner- or Andersen-cascade impactor
- Treatment of exhaust air: aerosol filter (absorbent cotton) and + combustor
- Temperature, humidity, pressure in air chamber: 24 °C, 25 %


TEST ATMOSPHERE
- Brief description of analytical method used: GC
- Samples taken from breathing zone: yes

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: see "any other information on materials and methods including tables"
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): see "any other information on materials and methods including tables"
- stability of test atmosphere: total carbon analyzer (Ratfisch RS 55)
Analytical verification of test atmosphere concentrations:
yes
Remarks:
see (I)
Duration of exposure:
4 h
Concentrations:
- 37.6, 150.6, 177.3, 289.3, 449.1 mg/m³, (respective contribution to the concentrations by particles: 0.0, 2.3, 18.8, 44.7, 165.5 mg/m³)
No. of animals per sex per dose:
- 5
Control animals:
other: animals of the study were compared to periodically tested animals (once per 3 month, clean air)
Details on study design:
- Duration of observation period following administration: 28 days
- Frequency of observations: several times on day 0, daily thereafter; frequency of weighing: day 1, day 3, day 7, day 14 and day 28
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, gross necropsy
Statistics:
Maximum-Likelihood where applicable

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LC50
Effect level:
170 mg/m³ air
Based on:
test mat.
95% CL:
137 - 213
Exp. duration:
4 h
Sex:
male
Dose descriptor:
LC50
Effect level:
150 mg/m³ air
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: this value was approximated, as the slope of dose response curve was very steep
Sex:
female
Dose descriptor:
LC50
Effect level:
201 mg/m³ air
Based on:
test mat.
95% CL:
157.7 - 257.9
Exp. duration:
4 h
Mortality:
- see table on mortality, body weight decrease, clinical signs and necroscopy
- mortality occurred between day 1 and day 14 post application
Clinical signs:
- clinical signs reported for days 0,1,2,3,7,14,21,28
- see table on mortality, body weight decrease, clinical signs and necroscopy
Body weight:
- see table on mortality, body weight decrease, clinical signs and necroscopy
Gross pathology:
- see table on mortality, body weight decrease, clinical signs and necroscopy
Other findings:
- reflexes: see table on mortality, body weight decrease, clinical signs and necroscopy

Applicant's summary and conclusion

Interpretation of results:
Category 2 based on GHS criteria
Remarks:
Migrated information
Conclusions:
Under the conditions of this acute inhalation toxicity study a combined LC50 for both sexes of 170 mg/m³ air (137 — 213, 95% CL) and a LD50 for males of 150 mg/m³ air were deduced for rats.