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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: no guideline defined, but available information is sufficient for assessment

Data source

Reference
Reference Type:
publication
Title:
Über das Verhalten des Organismus bei Einwirkung verschiedener Weichmacher
Author:
Bornmann G, Loeser A, Mikulicz K, Ritter K
Year:
1956
Bibliographic source:
Zeitschrift für Lebensmittel-Untersuchung und -Forschung, June 1956, Volume 103, Issue 6, pp 413-424, DOI: 10.1007/BF01683646

Materials and methods

Principles of method if other than guideline:
Method according to Kärber G, Naunyn-Schmiedebergs Arch. exper. Pathol. Pharmakol. 162, 480 (1931).
Rats were given different doses by gavage of undiluted 'Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate' and observed for 7 days for clinical signs and mortality.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate
EC Number:
905-983-8
Molecular formula:
C21H32O4; C22H42O4; C20H22O4
IUPAC Name:
Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate
Test material form:
liquid

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMAL
- Weight at study initiation: 120-180 g
- Housing: single
- Diet ad libitum
- Water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): >20

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Rats wer given different doses by gavage of undiluted 'Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate' and observed for 7 days for clinical signs and mortality.
Method according to Kärber G, Naunyn-Schmiedebergs Arch. exper. Pathol. Pharmakol. 162, 480 (1931).
Doses:
no details given
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
Rats wer given different doses by gavage of undiluted 'Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate' and observed for 7 days for clinical signs and mortality.
Method according to Kärber G, Naunyn-Schmiedebergs Arch. exper. Pathol. Pharmakol. 162, 480 (1931).
Statistics:
calculation according to Burn JH, Biologische Auswertungsmethoden p. 29, Berlin: Springer 1937

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
10.4 mL/kg bw
Remarks on result:
other: 10400 mg/kg bw
Mortality:
no details given
Clinical signs:
other: somnolenz, staggering gait, diarrhea, poor general condition
Gross pathology:
no data

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

10 rats per dose received different doses of undiluted 'Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate' by gavage and were observed for 7 days for mortality and clinical finings. Animals showed staggering gait, somnolenz, suffered from diarrhea and poor general condition. The LD50 is 10.4 ml/kg bw accounting for 10400 mg/kg bw (density = 1).