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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

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
Qualifier:
according to guideline
Guideline:
EPA OTS 798.1150 (Acute inhalation toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Bis(2-ethylhexyl) adipate
EC Number:
203-090-1
EC Name:
Bis(2-ethylhexyl) adipate
Cas Number:
103-23-1
IUPAC Name:
bis(2-ethylhexyl) adipate
Details on test material:
Please refer to confidential details on test material

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: breeding facility Dr. K. Thomae GmbH, Biberach, FRG
- Age at study initiation: approx. 8 - 9 weeks old
- Weight at study initiation: 206 g (females); 284 g (males)
- Housing:singly in cages type DK III (Becker, Germany).
- Diet: ad libitum
- Water:ad libitum
- Acclimatisation period:at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24°C
- Humidity: 30-70%
- Air changes (per hr): 12 hours light/12 hours dark


Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose/head only
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
Exposure system: Head-nose inhalation system INA 20 (glass-steel construction, BASF AG, volume V ~ 55L).
Technical equipment:
piston metering pump KP 2000 (Desaga)
two-component atomizer Mod.970 (stainless steel, Schlick).
aerosol mixing vessel (glass, BASF AG)
cyclonic separator (glass, BASF AG).
Flow rate of the test substance to the atomizer: 35.0 mL/h.
Exposure: supply air flow of 1500 L/h, exhaust air flow of 1350 L/h.

Analytical determination method: Gravimetric determination of the inhalation atmosphere concentration.
In addition, particle size was analyzed.
Equipment:
Stack Sampler Mark III (Andersen)
Vacuum Compressed Air Pump (Millipore)
Sampling probe (internal diameter 6.9 mm)
Limiting orifice 3 L/min
Balance: Sartorius M3P and Sartorius LC 1201S.
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
5.7 mg/L
No. of animals per sex per dose:
5 rats
Control animals:
no
Details on study design:
Duration of observation period: 14 days.
Clinical examinations: body weight (prior to exposure, after 7 days and after 14 days). Other clinical signs and findings.
Pathology: gross-pathological examination.
Statistics:
Probit analysis.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5.7 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Mortality:
No lethality occured at the tested concentration of 5.7 mg/L during the study period of 14 days. Therefore, the study satisfied the criteria of a limit test (LC50 > 5.7 mg/L).
Clinical signs:
other: Clinical examination revealed irregular and accelerated respiration as well as attempts to escape and piloerection. No clinical signs could be detected from post dosing day 5 onward.
Body weight:
Body weight development of the animals was not influenced.
Gross pathology:
No macroscopic pathological findings were noted in animals examined at the end of the study.
Other findings:
Particle size distribution, expressed as mass median aerodynamic diameter (MMAD), was calculated to be 1.4 µm.

Applicant's summary and conclusion