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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
17.10.2010 to 16.05.2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2011

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.2 (Acute Toxicity (Inhalation))
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
1,4-Benzenedicarboxylic acid, 1,4-diisononyl ester
EC Number:
700-453-0
Cas Number:
59802-05-0
Molecular formula:
C26H42O4
IUPAC Name:
1,4-Benzenedicarboxylic acid, 1,4-diisononyl ester
Test material form:
liquid

Test animals

Species:
rat
Strain:
other: Crl:CD (SD)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd
- Age at study initiation: 62 to 69 days
- Weight at study initiation: 329 to 396 g for
males and 212 to 256 g for females
- Housing: The animals were housed one animal per cage during the preliminary phase and five of one sex per cage during the main study. The cages were made of a polycarbonate body with a stainless steel mesh lid.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: least 5 days before treatment

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 23°C
- Humidity (%): 40 to 70%
- Air changes: Each animal room had its own supply of filtered fresh air, which was passed to atmosphere
and not re-circulated.
- Photoperiod (hrs dark / hrs light): 12 hours continuous light and 12 hours continuous dark per 24 hours

IN-LIFE DATES: From: 02/12/2010 To: 29/12/2010

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose only
Vehicle:
air
Mass median aerodynamic diameter (MMAD):
2.5 µm
Geometric standard deviation (GSD):
2.9
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: The inhalation exposure system comprised an ADG snout-only inhalation exposure chamber, restraining tubes, a jet atomiser, air supply and extract lines, which attached to the top and bottom of the chamber respectively and an air supply to the atomiser. A filtration system was incorporated in the extract line.
- Exposure chamber volume: approximately 30 litres
- Source and rate of air: The compressed air flow rate exiting the jet atomiser was 9 litres/minute; the extract airflow
rate was set at 10 litres/minute.
- Method of conditioning air: Air supply and extract were monitored using in-line
flowmeters, checked at intervals throughout the exposure and recorded manually.
- System of generating particulates/aerosols: The aerosol generator, a stainless steel concentric jet atomiser (manufactured in house by Inhalation Engineering services), was designed to produce and maintain an atmosphere containing a high proportion of respirable droplets.
- Method of particle size determination: The mass median aerodynamic diameter (MMAD) and the geometric standard deviation (σg) of the droplet aerosol were calculate assuming a log-normal distribution of particle size.



TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: A measured volume of air was drawn at a rate of approximately 2 litres/minute from inhalation exposure chamber through a Marple Model 296 Personal Cascade Impactor (Andersen Instruments, Smyrna, Georgia, USA) attached to the chamber.

Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
4 h
Concentrations:
5.22 mg/l
No. of animals per sex per dose:
1 control and 1 test group, each consisting of 5 male and 5 female animals
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed intermittently for signs of reaction to the test substance during exposure and at least twice daily throughout the observation period. The weight of each main study animal was recorded on Days 1 (prior to dosing), 2, 4, 8 and 15.
- Other examinations performed: clinical signs, body weight, lung weights, histopathology

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
5.2 mg/L air
Based on:
test mat.
Mortality:
There were no unscheduled deaths.
Clinical signs:
other: Wet fur was evident for a proportion of animals from both groups and was considered to be related to the restraint procedure.
Body weight:
There were no treatment related effects on bodyweight.
3.4 Lung
Gross pathology:
The macroscopic examination performed after a single exposure and a 14 day observation
period revealed enlargement of the liver in three treated male animals. This finding most
likely reflected the large size of these animals rather than exposure to the test substance.
The nature and incidence of all other findings were consistent with the commonly seen
background of macroscopic changes.

Applicant's summary and conclusion

Conclusions:
Under the conditions of this study the LC50 (4 hour) of Bis(C9(Branched)Alkyl) Benzene-1,4-Dicarboxylate
is in excess of 5.20 mg/L for male and female rats.