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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:
30-10-1984 to 13-11-1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
(non-GLP study)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report): Sicopal-GElb FA 7295, Sicopal-Gelb L-1110
- Physical state: solid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomas GmbH, 7950 Biberach, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 weeks
- Weight at study initiation: 251-290 g (males), 168-201 g (females)
- Housing: 5 rats/ cage, suspended D III cage
- Diet: KLIBA Labordiät Ratte/Maus A 343 10 mm Pellet, ad libitum
- Water: tap water, ad libitum

ENVIRONMENTAL CONDITIONS 9set conditions)
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 30-10-1984 To: 13-11-1984

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
nose/head only
Vehicle:
other: The test substance was mixed with Aerosil E 200 at 5% w/w to improve pourability.
Mass median aerodynamic diameter (MMAD):
2.6 µm
Geometric standard deviation (GSD):
3.3
Remark on MMAD/GSD:
The percentage of fine particulates in the atmosphere was calculated to be 88.5%.
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: INA 20 (Glas-Stahl-Konstruktion, BASF Aktiengesellschaft), dust generation with Vibratomat
- Exposure chamber volume: ca. 55 L
- Method of holding animals in test chamber: animals were placed in a tube
- Rate of air: 1500 L/hour
- Method of particle size determination: gravimetrically
- Temperature in air chamber: 19 - 25°C

TEST ATMOSPHERE
- Brief description of analytical method used: air was filtered and and concentration was determined gravimetrically (according to Silverman, L.: Particle Size Analysis in Industrial Hygiene, 1971, p. 235 - 259)
- Samples taken from breathing zone: yes
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
5.15 mg/L (after correction for Aerosil content)
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observation and weighing: rats were observed daily, body weights were determined before exposure, on day 7 and day 14 after exposure
- Necropsy of survivors performed: yes (gross pathology)

Results and discussion

Effect levels
Key result
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:
During exposure rats were observed with increased breathing rate. After expsoure, rats were observed with increased and intermittent breathing and scrubby fur. These symptoms disappeared by day six of exposure.
Body weight:
Body weight increase was comparable to historical control data.
Gross pathology:
Gross pathology revealed slightly yellow lungs in the sacrificed animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on an acute inhalation study with Sicopal-Gelb L-1 110, the LC50 following four hour inhalation exposure to the test substance was concluded to exceed 5.15 mg/L for male and female Wistar rats.
Executive summary:

An acute inhalation study was performed with Sicopal-Gelb L-1 110 (a test substance with approximately 57% bismuth vanadate oxide and 43% Bismuth molybdenum oxide) equivalent to OECD guidelines. Male and female Wistar rats (10/sex) were exposed for 4 hours to 5.15 mg/L (MMAD of the particles = 2.6µm). During exposure rats were observed with increased breathing rate. During the 14 days observation period, rats were observed with increased and intermittent breathing and scrubby fur. These symptoms disappeared by day six of exposure. No mortality occurred up to 14 days after exposure. No alterations in body weight increase of the exposed rats was found. At necropsy, slightly yellow lungs in the sacrificed animals was observed. Based on these results, the LC50 was concluded to exceed 5.15 mg/L for male and female Wistar rats.