Registration Dossier

Administrative data

acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1 July - 5 August, 1983
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Conducted prior to GLP. No information on the purity of the test sample. No clear information on the conditions of exposure but it seems to be whole body. Thes test was carried out at he maximum achievable concentration.

Data source

Reference Type:
study report
Report Date:

Materials and methods

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

Test material

Test material form:
solid: particulate/powder
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Busan 11-M1
- Substance type: No data
- Physical state: White powder
- Analytical purity: No data
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: No data
- Lot/batch No.: 6-5606
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: Room temperature

Test animals

Details on test animals and environmental conditions:
- Source: Charles River Breeding Laboratories, Inc., Kingston, NY
- Age at study initiation: males 45 - 53 days, females 71 - 85 days (upon arrival)
- Weight at study initiation: Males mean group weight range 233.6 - 241.0 g, Females mean group 221.4 - 241.6
- Fasting period before study: No data
- Housing: Individually in stainless steel wire-mesh cages
- Diet (e.g. ad libitum): Purina Rodent Laboratory Chow at libitum during nonexposure periods
- Water (e.g. ad libitum): Tap water ad libitum during nonexposure periods
- Acclimation period: at least one week

- Temperature (°C): 21.67 - 25.56 °C
- Humidity (%): 61 - 84% during study, 42 - 49% during exposure
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

IN-LIFE DATES: From: 01/07/1983 To: 05/08/1983

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
whole body
not specified
Details on inhalation exposure:
- Exposure apparatus: Plexiglass chamber (control group), glass and stainless steel chambers (exposed groups)
- Exposure chamber volume: 100L
- Method of holding animals in test chamber: in cages
- Source and rate of air: Generation system and accessory chamber, total chamber airflow 16.7 L/min.
- Method of conditioning air: Wright dust feeds (2) generating into the tangential input duct on the turret top
- System of generating particulates/aerosols: Wright dust feeds (2)
- Method of particle size determination: samples obtained using Andersen Mini Sampler Cascade Impactor placed inside the chamber on top of animal cages
- Treatment of exhaust air: No data
- Temperature, humidity, pressure in air chamber: temperature 23.33 - 23.89, humidity 42 - 49% , no data on pressure

- Brief description of analytical method used: gravimetric concentrations were determined as outlined in "Any other information on materials and methods" below
- Samples taken from breathing zone: yes

No data

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution:
- MMAD (Mass median aerodynamic diameter): Group 2: Mean = 3.4, S.D. = 0.28; Group 3: Mean 2.8, S.D = 0.14
- GSD (Geometric st. dev.): Group 2: Mean = 1.8, S.D. = 0.13; Group 3: Mean 1.9, S.D = 0.05
Analytical verification of test atmosphere concentrations:
gravimetric concentrations
Duration of exposure:
4 h
Nominal: Group 2 = 14.52 mg/L, Group 3 = 21.70 mg/L
Mean gravimetric concnetrations: Group 2 = 2.98 mg/L (S.D. = 0.15), group 3 = 3.54 mg/L (S.D. = 1.394)
No. of animals per sex per dose:
Control animals:
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed prior to exposure, at the start of exposure and at 30 minute intervals during exposure. The animals were observed twice daily for 14 days post exposure. Body weights of all animals were recorded immediately prior to exposure and on Days 2, 3, 4, 7 and 14 post exposure.
- Necropsy of survivors performed: yes
- Other examinations performed: Special attention was paid to lungs and respiratory tract during necropsy. The lungs, lever, kidneys and any other organs exhibiting gross pathologic changes were removed and fixed for histopathology.
No data

Results and discussion

Effect levelsopen allclose all
Dose descriptor:
Effect level:
> 21.7 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: Maximum attainable concentration
Dose descriptor:
Effect level:
> 3.54 mg/L air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: Maximum attainable concentration
One Group 2 male was found dead on Day 2 and one Group 3 female was found dead on Day 1 of exposure.
Clinical signs:
During exposure, all Group 2 and 3 animals appeared languid from 30 min through 4 hours. Group 2 animals showed slight dyspnea from hour 2 through 4. Group 2 animals showed rhinorrhea from hour 1 through 4. Dust covered the fur of all Group 2 and 3 animals.
On day 1 post exposure Group 3 animals showed the following clinical signs: 3 males and 1 female appeared languid, blood crusts were observed around the nose of 1 male and 1 female and polypnea and wheezing were observed in 1 male and 1 female. All remaining Group 3 animals appeared normal from Day 2 through termination.
Body weight:
Mean body weights of the Group 1 (control) females decrease slightly on days 2 and 4 post exposure. Mean body weights of both sexes of test groups decrease markedly on Day 2 and increased steadily thereafter with the exception of a decrease in the Group 2 female mean body weight on day 14.
Gross pathology:
7 Group 1 (control) animals, 7 of the Group 2 animals and 8 of the group 3 animals had no gross pathology observations.
The lungs of one Group 1 (control) animal showed scattered pinpoint red areas. The lobes of the lung of the Group 2 animal found dead were dark red, and those of the Group 3 animal found dead failed to collapse when thoracic cavity was opened. One or both renal pelves were dilated in one Group 1 (control) female, one Group 2 female and one Group 2 male. The uterine horns of two Group 1 (control) females and one group 3 females were distended with clear fluid.
Other findings:
No further data

Any other information on results incl. tables

No further data

Applicant's summary and conclusion

Interpretation of results:
not classified
Migrated information Criteria used for interpretation of results: EU
The inhalation LC50 was found to be >3.54mg/L air (analytical) the maximum attainable concentration. Therefore it does not warrent classification of acute inhalation toxicity according to EU legislation
Executive summary:

In a study conducted by Coate (1983), the test substance, Busan 11-M1, was examined for its ability to cause toxicity when administered via whole-body inhalation to male and female Sprague-Dawley rats. The test animals were exposed to nominal concentrations of the test substance 14.52 mg/L and 21.70 mg/L. The test animals were exposed to the test substance via whole-body inhalation for a period of up to 4 hours. They were then observed for 14 days following treatment to determine the effects. Under the conditions of this study, there were no test substance related mortalities observed and no test substance related adverse effects recorded. The LC50 is greater than >3.54mg/L air (analytical) the maximum attainable concentration.  Based on this result, the test substance does not require classification for acute inhalation toxicity according to Regulation EC No. 1272/2008.