Registration Dossier

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:
other: according to OECD TG and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
yes
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
content 99.1 %
red powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 2 month
- Weight at study initiation: 180-200 g
- Fasting period before study:
- Housing: before test : singly and during test in groups
- Diet ad libitum
- Water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 40-60
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
nose only
Vehicle:
clean air
Details on inhalation exposure:
target concentration 5000 mg/m³
mean gravimetric concentration 2868 mg/m³
maximum technically attainable concentration
inlet air flow 28 l/min (concurrent control : air. 15 l/min)
exhaust air flow: 23.8 l/min (concurrent control: 12.8 l/min)
mean temperature 22.4.°C (concurrent control: 22.4°C
mean rel humidity 10.3 % (concurrent control: 5.1 %)
Mass Median Aerodynamic Diameter(MMAD) 4.78 µm
Aerosol Mass < 3 µm: 22 %
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
ca. 4 h
Concentrations:
target concentration 0 or 5000 µg/m³ (maximum technically attainable mean concentration: 2868 mg/m³)
No. of animals per sex per dose:
5 rats /sex and concentration
Control animals:
yes
Details on study design:
according to the respective guideline , 2 weeks post exposure observation
To identify exposure related effects, comparisons with an appropriate vehicle control were performed. This control was exposed to an atmosphere using essentially similar exposure conditions as were used for the test substance.
body weight determination on days 1, 3, 7 and weekly thereafter
deaths were recorded
clinical signs and appearance and behavior of each rat were recorded
Necropsy was performed
and gross pathological changes were notet (if available)
Statistics:
one-way ANOVA
The particle-size distribution was analyzed using an ANDERSEN critical orifice
cascade impactor.
Mass Median Aerodynamic Diameter (MMAD): Construct a 'Cumulative Percent
Found - Less Than Stated Particle Size' Table, calculate the total mass of test
substance collected in the cascade impactor.
Calculation of Geometric Standard Deviation (GSD): Refer to the log probability
graph used to calculate the Mass Median Aerodynamic Diameter

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 2 868 mg/m³ air (analytical)
Exp. duration:
4 h
Mortality:
no rat died
Clinical signs:
other: no specific clinical signs were observed
Body weight:
Comparisons between the control and the exposure group did not reveal changes in body weights of toxicological significance



in body weights of no toxicological significance
Gross pathology:
-Animals sacrificed at the end of the observation period:
No macroscopic findings
Other findings:
no further data

Any other information on results incl. tables

Target concentration: 5000 mg/m³

Gravimetric concentration: 2868 mg/m³

MMAD:                             4.78 µm

GSD                                   1.82

Aerosol Mass <3 µm:       22.0 %

Mass recovered:              2228 mg/m³

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Executive summary:

A study on acute inhaltion toxicity of Macrolex Rot EG on rats has been conducted in accordance with OECD TG 403. A group of male and female rats was nose-only exposed to the dry powder aerosol of the test article at an actual concentration of 2868 mg/m³.. No animal died, no clinical findings and no pathotlogical changes were noted. Therefore, the results can be summarized as follows:

LC50 (rat) > 2868 mg/m³, the maximum technically attainable concentration.