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

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzyl 2-ethylhexyl adipate
EC Number:
261-234-9
EC Name:
Benzyl 2-ethylhexyl adipate
Cas Number:
58394-64-2
Molecular formula:
C21H32O4
IUPAC Name:
benzyl 2-ethylhexyl adipate
Constituent 2
Chemical structure
Reference substance name:
Bis(2-ethylhexyl) adipate
EC Number:
203-090-1
EC Name:
Bis(2-ethylhexyl) adipate
Cas Number:
103-23-1
Molecular formula:
C22H42O4
IUPAC Name:
bis(2-ethylhexyl) adipate
Constituent 3
Chemical structure
Reference substance name:
Dibenzyl adipate
EC Number:
219-516-4
EC Name:
Dibenzyl adipate
Cas Number:
2451-84-5
Molecular formula:
C20H22O4
IUPAC Name:
dibenzyl adipate
Test material form:
liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 9-12 weeks
- Weight at study initiation: males: 293-322 g, females: 215-230 g
- Housing: singly
- Diet ad libitum except during exposure
- Water (e.g. ad libitum except during exposure)
- Acclimation period: 23 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23
- Humidity (%): 46-56
- Air changes (per hr): 13
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
nose only
Vehicle:
air
Details on inhalation exposure:
The animals were exposed to the test atmosphere for 4 hours and 5 minutes. The exposure period was extended beyond 4 hours to allow the chamber to reach equilibrium. At the end of the exposure period the generation was terminated and the chamber was operated for a further 15 min with clean air. At the end of this period the animals were removed from the exposure tube. Prior to being returned to their cages excess test substance was removed from the fur of each animal.

Atmosphere generation:
The test atmosphere was generated using a 1/4 inch JCO atomizer.
Chamber concentration measurements
Particel size distribution measurements
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
ca. 4 h
Concentrations:
5.08 mg/L = 5080 mg/m³
No. of animals per sex per dose:
5 males and 5 females
Control animals:
not specified
Details on study design:
The animals were exposed to the test atmosphere for 4 hours and 5 minutes. The exposure period was extended beyond 4 hours to allow the chamber to reach equilibrium. At the end of the exposure period the generation was terminated and the chamber was operated for a further 15 min with clean air. at the end of this period the animals were removed from the exposure tube. Prior to being returned to their cages excess test substance was removed from the fur of each animal. The animals were observed for 14 days.
Statistics:
no data

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5 000 mg/m³ air
Exp. duration:
4 h
Remarks on result:
other: all animals survived
Mortality:
No animal died.
Clinical signs:
other: Follwing exposure all animals exhibited irregular respiration but recovered from this sympton by day 3.
Body weight:
All animals lost body weight by day 1 but showed a continued weight gain thereafter through day 14.
Gross pathology:
No gross abnormalities were detected at the end of the 14 day observation period.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

An acute inhalation toxicity test according to OECD TG 403 was conducted to determine the potential of 'Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate' to produce toxicity from a 4-hour exposure via inhalation (nose-only exposure) route.

The test atmosphere was generated using a 1/4 inch JCO atomizer. The gravimetric chamber concentration was 5080 mg/m³. The mass median aerodynamic diameter was estimated to be 1.72 µm. All animals survived the exposure to the test atmosphere. Following exposure all animals exhibited irregular respiration. However, the animals recovered from this symptom by day 3 and appeared active and healthy for the remainder of the 14-day observation period. Although all animals lost body weight by day 1, all animals showed a continued weight gain thereafter through day 14. No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period. Thus, the LC50 is > 5000 mg/m³.