Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Few details on materials and methods were given, the individual animal data was not reported, no necropsy was performed, the airflow was not monitored, air changes per minute were not reported, the type of inhalation exposure was not specified. The requirements of the listed guideline were not available.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: The Guidelines for the Testing of Chemicals (State Environmental Protection Administration of China) 2004.5
Deviations:
no
Qualifier:
according to
Guideline:
other: The Guidelines for the Hazard Evaluation of New Chemical Substances (HJ/T 154-2004)
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
adopted Sep 2009
Deviations:
yes
Remarks:
few details on materials and methods were given, individual animal data not reported, no necropsy was performed, air changes per minute not reported, airflow was not monitored, the type of inhalation exposure not specified
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

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

Test animals

Species:
rat
Strain:
other: SPF Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Vital River Laboratory Animal Technology Co. Ltd., Beijing, China
- Weight at study initiation: 252.2 ± 1.9 g (females) and 258.0 ± 4.9 g (males)
- Housing: animals were housed individually
- Diet: rodent feed (HFK BIOSCIENCE Co., Ltd., Beijing, China), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 25
- Humidity (%): 55 ± 15
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
not specified
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Dynamic inhalation control system (HOPE-MED8051C), solid phase dust inhalation chamber (8051) and automatic dust dynamic control system (8051C) (Tianjin HOPE Co., Ltd., Tianjin, China); dust sampler and filter membrane (Yancheng Kebo Electron Instrument Co., Ltd., Jiangsu, China)
- Exposure chamber volume: 300 L
- Source and rate of air: 4.0 m³/h
- System of generating particulates/aerosols: dust of the test substance was generated with the dust generator and entered the inhalation chamber at a rate of 2.8 mL/min.

TEST ATMOSPHERE
- Brief description of analytical method used: gravimetric method. Samples of the test substance were collected at 1, 2 and 3 h using a dust sampler equipped with a filter membrane that had been weight prior to sampling. The weight minus filter weight was used as the sample weight.
Analytical verification of test atmosphere concentrations:
yes
Remarks:
gravimetric method
Duration of exposure:
4 h
Concentrations:
5 mg/L (nominal concentration)
5.47 mg/L (analytical concentration)
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: the animals were observed for mortality and clinical signs immediately after exposure, and daily thereafter for the rest of the study period; the body weight was recorded on Day 0 (prior to dosing), 7 and 14
- Necropsy of survivors performed: no

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5.47 mg/L air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Mortality:
No mortality occurred during the study period.
Clinical signs:
other: No clinical signs of toxicity were observed during the 14-day observation period.
Body weight:
The body weight gains were within the normal ranges in males and females during the whole study period.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
CLP: not classified