Esterification product of sunflower-oil fatty acids, with 1,4:3,6-dianhydro-D-glucitol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 03 April 2009 to 06 June 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: study performed according to OECD testing guideline and GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

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:

64896-70-4

Cas Number:

64896-70-4

IUPAC Name:

64896-70-4

Test material form:

liquid: viscous

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River USA
- Age at study initiation: 8-12 weeks
- Weight at study initiation: ca. 175 grams
- Fasting period before study: yes (feed only)
- Housing: standard polypropylene rat cages with stainless steel top grill
- Diet: standard gamma irradiated pellet feed supplied by M/s. Tetragon Chemie Pvt. Ltd., Bangalore, ad libidum
- Water: ad libitum
- Acclimation period: yes (5 days)

ENVIRONMENTAL CONDITIONS
- Temperature: 19.4°C to 22.4°C
- Humidity: 56% to 64%
- Air changes: -
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: 18 April 2009 To: 04 May 2009

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: -
- Justification for choice of vehicle: -
- Lot/batch no. (if required): -
- Purity: -

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

CLASS METHOD
- Rationale for the selection of the starting dose: -

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6 females (3 females per step)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
> body weight: days 0, 7 and 14
> morbidity/mortality: once daily
> clinical signs: at 0.5, 1, 2 and 4 hours after dosing, and once daily thereafter
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality/morbidity was observed in animals throughout the observation period.

Clinical signs:

No clinical signs were observed in animals throughout the observation period.

Body weight:

All the animals showed normal body weight during the experiment period.

Gross pathology:

Animals did not reveal any macroscopic lesions.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 of DOI is > 2000 mg/kg bw (with no mortality at this dose level).

Executive summary:

In an acute oral toxicity study according to OECD 423, and GLP, scored as validity 1 according to Klimisch criteria, groups of fasted female Wistar rats were given a single oral dose of DOI in corn oil at the dose of 2000 mg/kg bw (2x3 females) and observed for 14 days. Clinical signs and mortality were checked frequently during the hours following administration of the test substance, and once a day thereafter. Body weight was measured just before administration of the test substance on day 0 and then on days 7 and 14.

 

No clinical signs of toxicity and no mortality were observed during the study.

At necropsy, no apparent abnormalities were observed in any animal.

Under the experimental conditions, the oral LD50 of the test item DOI was higher than 2000 mg/kg in rats.

No classification for acute oral toxicity is warranted based on the absence of mortality up to 2000 mg/kg bw, according to the criteria of Annex VI Directive 67/548/EEC or UN/EU GHS.

This study is classified as acceptable, as it is performed according to OECD guideline and GLP.