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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:
July - Aug 2021
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2021

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Test material form:
solid: nanoform
Details on test material:
Heliogen Blau BGN
Lot Number: 210014P050
Date of production: 22 Feb 2021

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH,
- Age at study initiation: on study day 0: (male animals xx days, female animals yy days)
- Weight at study initiation: animals of comparable weight (+/- 20% of the mean body weight)
- Fasting period before study: no
- Housing: single houing or up to 5 animals
- Diet: Kliba laboratory diet, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20–24 °C
- Humidity: 30-65 %
- Air changes: 15 changes per hour
- Photoperiod: 12 hours light / 12 hours dark

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
nose only
Vehicle:
air
Mass median aerodynamic diameter (MMAD):
>= <= µm
Geometric standard deviation (GSD):
>= <=
Remark on MMAD/GSD:
Two samples were analyzed.
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: For each test group the dusts were produced inside the inhalation system with a dust generator and compressed air and passed into the inhalation system. The concentrations were adjusted by varying the apertural width rotation of the dosing wheel of the dust generator.
- Exposure chamber volume: 34 L
- Method of holding animals in test chamber: restraining tubes
- Source and rate of air: central air conditioning system,1.5 m³/h
- Method of conditioning air: Central air conditioning system provided cold air of about 15°C. This cold air passed through an activated charcoal filter, adjusted to room temperature of 20 to 24°C and passed through a second particle filter (H13 (HEPA) Camfil Farr, Germany). The so generated conditioned air was used to generate inhalation atmospheres.
- System of generating particulates/aerosols: The test item was stirred in its container before a sample for dust generation was taken. The test item was desagglomerated in a mixer (mixing for 10 seconds) before introduction into the dust generator via the dosing wheel (Gericke/BASF).
- Method of particle size determination: Stack Sampler Mark III (Andersen). Before sampling, impactor stages were assembled with preweighed glass fiber collecting discs, and equipped with a backup particle filter. The impactor was connected to a vacuum pump, and for each test group samples were taken from the breathing zone of the animals. Sampling occurred 30 minutes (or later) after the beginning of the exposure.
- Treatment of exhaust air: The exhaust air was filtered and conducted into the exhaust air of the building.

TEST ATMOSPHERE
- Brief description of analytical method used: gravimetric, filtration equipment with probe, internal diameter: 7 mm, Sampling Volume 15L, 4 samples at about hourly intervals
- Samples taken from breathing zone: yes

VEHICLE
none apart from air


TEST ATMOSPHERE:
- Particle size distribution: Based on cascade impactor measurements. The calculation of particle size distribution was carried out by means of mathematical methods for evaluating particle measurements.
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
1 and 5 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: Individual body weight was determined once during the acclimatization period, at the start of the exposure period (Day 0) and at least on Days 1, 3 and 7, and weekly thereafter, or before the sacrifice of the animals at the end of the observation period.
- Clinical observations were recorded for each animal before exposure, separately several times during exposure (usually hourly) and after exposure. At least once daily on the preexposure day and during the post exposure observation period.
- Necropsy of survivors performed: yes

Pathology: At the end of the observation period the surviving animals were sacrificed with CO2-inhalation in a chamber with increasing concentration over time and were subjected to gross pathological examination as well as the animal which died before. To clarify the gross pathological findings, selected organs of individual animals were examined histopathologically.


Statistics:
LC50 values were calculated for males, females and both sexes combined using a binomial test.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: awaiting draft report.

Applicant's summary and conclusion