Bis(2-ethylhexyl) carbonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2002-01-23 to 2002-02-08

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

22 March 1997

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

amended Directive (96/54/EEC) dated 30 September 1996, Annex IVB

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Bis(2-ethylhexyl) carbonate

EC Number:

238-925-9

EC Name:

Bis(2-ethylhexyl) carbonate

Cas Number:

14858-73-2

Molecular formula:

C17H34O3

IUPAC Name:

bis(2-ethylhexyl) carbonate

Test material form:

other: liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: no data
- Weight at study initiation: males: 246 - 270 g; females: 163 - 167 g
- Fasting period before study: Fasted from 16 h before until 3-4 h after the administration of the test article. Water was available ad libitum during this period.
- Housing: housed collectively at 3 animals per cage (Makrolon® III)
- Diet: ad libitum, standard laboratory rat diet Teklad Global 18 % Protein Rodent Diet (pelleted diet, batch no.: H141) produced by Harlan Teklad, Shaw's farm, Blackthorn Bicester, Oxon, OX6 OTP, England
- Water: ad libitum, tap water as for human consumption
- Acclimation period: 7 days (females); 9 days (males)


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 16
- Photoperiod (hrs dark / hrs light): Artificial light was set to give a cycle of 12 hours light and 12 hours dark with light on at 7.00 a.m.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: applied undiluted

MAXIMUM DOSE VOLUME APPLIED: Since the density of the liquid test article was determined as 0.89 g/ml, the test article was administered at a volume of 2.25 ml/kg body weight which corresponded to a dose of 2000 mg/kg bw.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The test was carried out in one step in 3 female and 3 male animals. Initially, the dose of 2000 mg/kg bw was administered to 3 female rats. Since no mortality was observed within 48 hours, the test article was administered subsequently to 3 male rats at the same dose of 2000 mg/kg bw.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations : In each animal a number of clinical-toxicological signs were evaluated according to a modified IRWIN Screening procedure and observed findings were recorded. The animals were examined during 10 min after dosing and at the following post-treatment intervals: 1 h, 2 h, 6 h, 24 h and thereafter once daily up to day 14.
- Frequency of weighing: Body weights were recorded immediately before treatment and on days 7 and 14 p.a. (termination).
- Necropsy of survivors performed: yes

Statistics:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: approx. 100 % a.i.; no animal died

Mortality:

0/6 - No animal died during the course of the 14-day observation period following the orally administered dose of 2000 mg/kg bw.

Clinical signs:

other: No clinical signs were observed during the 14-day observation period.

Gross pathology:

Gross pathological examinations on day 14 p.a. (terminal necropsy) did not reveal abnormal macroscopic findings.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)

Conclusions:

On the basis of the results obtained after a single oral administration in rats, the oral LD50 of Bis(2-ethylhexyl) carbonate was determined to be > 2000 mg/kg bw. No significant clinical signs, changes in body weight or gross pathological findings were observed.

Executive summary:

In an acute oral toxicity study according to EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method) dated 30 September 1996 and OECD Guideline 423, 22 March 1997, 3 male and 3 female young adult Wistar rats were given a single oral dose of Bis(2-ethylhexyl) carbonate, approx. 100 % a.i.) at a dose of  2000 mg/kg bw (limit test) and observed for 14 days.

 

Oral LD₅₀ Males and Females > 2000  mg/kg bw

No animal died during the course of the 14-day observation period following the dose of 2000 mg/kg bw.

No clinical signs were observed.

There was no influence of the treatment on the body weight development in all male and female animals during the 14-day observation period.

Gross pathological examinations on day 14 p.a. did not reveal any finding.