Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Currently viewing:

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:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
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
Details on test material:
- Name of test material (as cited in study report): di(2-ethylhexyl)adipate
- Substance type: a clear colourless liquid
- Analytical purity: 100.4% (ester titration)
- Lot/batch No.: GC-2-27-76
- Storage condition of test material: at 4 degrees Celcius

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: NCI Frederick cancer institute
- Age at study initiation: 3 weeks
- Housing: 5 per cage
- Diet :e.g. ad libitum
- Water :e.g. ad libitum
- Acclimatisation period: 2 weeks


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-31
- Humidity (%): 10-88
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12


Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Doses:
0.08, 0.16, 0.31, 0.63, 1.25, 2.5 , 5.0, 10, 20 g/kg
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
Ten groups of five males and five females were administered a single dose of the test substance in corn oil by
gavage. The high doses were initiated after the start of the low dose groups (0.08- 1.25 g/kg).
All surviving animals were killed after 14 days .
Statistics:
no data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 20 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: The estimated LD50 was 45 g/kg for males and 24 .6 g/kg for females.
Mortality:
males and females: 1/5 at 20 g/kg
males: 2/5 at 10 g/kg
Clinical signs:
other: no data
Gross pathology:
no data

Any other information on results incl. tables

         Survival(a)

Dose(g/kg ) Male        Female

 

0.08            5/5           5/5

0.16            5/5           5/5

0.31            5/5           5/5

0.63            5/5           5/5

1.25            5/5           5/5

1.25(b)       5/5           5/5

2.50(b)       5/5           5/5

5.00(b)       5/5           5/5

10.00(b)     3/5          5/5

20.00(b)     4/5          4/5

(a) Number surviving/number per group

(b) The single dose acute toxicity study at these higher doses was initiated 1 week after the single dose acute toxicity study at lower doses .

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met