(1S)-1-{(2R)-3,4-bis[(2-hexyldecanoyl)oxy]-5-oxo-2,5-dihydrofuran-2-yl}ethane-1,2-diyl bis(2-hexyldecanoate)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

September 25 - October 09, 1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study is performed in accordance with OECD guideline 401 and meets the requirements of GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Directive 92/69/EEC, B.1 OECD 401

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material (as cited in study report): Nikkol VC-IP
- Substance type: Colourless to light yellow liquid
- Physical state: Liquid
- Stability under test conditions: stable
- Storage condition of test material: In refrigerator in the dark

Test animals

Species:

rat

Strain:

other: Wistar strain Crl:(WI)BR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany.
- Age at study initiation: Approx. 6 weeks.
- Weight at study initiation: 177-192 g (males), 147-163 g (femals)
- Fasting period before study: Food was withheld overnight prior to dosing until approximately 3-4 hours after administration of the test substance.
- Housing: Group housing of 5 animals per sex per cage
- Diet: Carfil Quality BVBA, Oud-Turnhout, Belgium
- Water: Tap-water, Certificates of quarterly analysis were examined and then retained in the NOTOX archives
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: No vehicle applied.

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: At periodic intervals on the day of dosing (day 1) and once daily thereafter; body weight on day 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic findings

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: Signs of toxicity related to dose levels: No mortality occured and no clinical signs of toxicity were observed.

Gross pathology:

Effects on organs: None.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 value of NIKKOL VC-IP in rats was established as exceeding 2000 mg/kg body weight.