Registration Dossier
Registration Dossier
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EC number: 825-571-0 | CAS number: 60428-79-7
Acute Toxicity: inhalation
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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Version / remarks:
- 2009
- GLP compliance:
- yes
- Limit test:
- yes
Test material
- Reference substance name:
- Molybdenum, bis(N,N-dibutylcarbamodithioato-κS,κS')dioxodi-μ-thioxodi-, stereoisomer
- EC Number:
- 825-571-0
- Cas Number:
- 60428-79-7
- Molecular formula:
- C18H36Mo2N2O2S6
- IUPAC Name:
- Molybdenum, bis(N,N-dibutylcarbamodithioato-κS,κS')dioxodi-μ-thioxodi-, stereoisomer
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: 268-300 (males), 203-228 g (females)
- Fasting period before study: no
- Housing: group housing up to 5 animals per cage and sex
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- Humidity (%): 49-54
- Air changes (per hr): >=
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To:
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Mass median aerodynamic diameter (MMAD):
- ca. 4.3 µm
- Geometric standard deviation (GSD):
- ca. 2.2
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: directed flow nose only inhalation chamber
- Exposure chamber volume:
- Method of holding animals in test chamber: restraining tubes
- Source and rate of air: approx. 1 l/min at each animal port
- Method of conditioning air:
- System of generating particulates/aerosols: Wright dust feeder
- Method of particle size determination: 8 stage Marple personal cascade impactor; collected dust fraction was determined gravimetrically
- Treatment of exhaust air: passed through a filter
- Temperature, humidity, pressure in air chamber: 20.1-21.6°C, 10-12%
TEST ATMOSPHERE
- Brief description of analytical method used:
- Samples taken from breathing zone: yes/no
VEHICLE
- Composition of vehicle (if applicable):
- Concentration of test material in vehicle (if applicable):
- Justification of choice of vehicle:
- Lot/batch no. (if required):
- Purity:
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: 0.5 µm - approx. 10 µm
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 4.3 µm, GSD 2.2
CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration: - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- ca. 4 h
- Concentrations:
- 5.0 +/- 0.1 mg/l
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observation, weighing on days 1, 2, 4, 8, 15
- Necropsy of survivors performed: yes, macroscopic
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC0
- Effect level:
- >= 5 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- no
- Clinical signs:
- other: after exposure, hunched posture and yellow staining (general) were seen for all animals between Days 1 and 4.
- Body weight:
- body weight loss was noted for all animals, this continued for three females up to Day 8, the animals regained weight during the second week.
- Gross pathology:
- no abnormalities observed
Applicant's summary and conclusion
- Interpretation of results:
- other: no death at limit concentration
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