Fatty acids, C14-22, ethylene esters, bisulfited, sodium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21 April 2010 - 01 June 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Rape oil, bisulfited, sodium salt

EC Number:

281-975-1

EC Name:

Rape oil, bisulfited, sodium salt

Cas Number:

84082-27-9

IUPAC Name:

-

Test material form:

liquid: viscous

Details on test material:

- Name of test material (as cited in study report): FLL sample 4
- Chemical name: Rape oil, bisulfited, sodium salt (triglycerides, C12 to C24 , even, saturated and unsaturated, bisulfited, sodium salt)
- Physical state: viscous liquid
- Purity: 90%
- Impurities: 10% water content by Karl Fischer
- Lot/batch No.: 240210
- Expiration date of the lot/batch: not reported
- Storage condition of test material: room temperature in the dark
- Other: yellow/brown color
- All other template details: Not reported

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories UK Ltd, Bicester, Oxon, UK
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 173 - 178 g
- Fasting period before study: overnight before dosing, and approximately 3-4 hours after dosing
- Housing: housed in groups of up to four in suspended solid-floor polypropylene cages furnished with woodchips
- Diet (e.g. ad libitum): ad libitium access to 2014 Teklad Global Rodent diet
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 degrees C
- Humidity (%): 30- 70 percent
- Air changes (per hr): at least 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark

IN-LIFE DATES: Not reported

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Remarks:

BP

Details on oral exposure:

VEHICLE: no details reported

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg

DOSAGE PREPARATION (if unusual): suspension of test item in distilled water

CLASS METHOD: not applicable
VEHICLE
- other: arachis oil BP was used for the 300 mg/kg dose level, no vehicle was used for the 2000 mg/kg dose level

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg

DOSAGE PREPARATION (if unusual): not applicable

CLASS METHOD: not applicable

Doses:

300, 2000 mg/kg

No. of animals per sex per dose:

1 animal at 300 mg/kg, 5 animals at 2000 mg/kg

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observations, weighed at days 0, 7, 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross necropsy (external examination and opening of abdominal and thoracic cavities to look for macroscopic abnormalities)

Statistics:

None reported

Results and discussion

Preliminary study:

One animal was treated with 300 mg/kg bw test material suspended in Arachis oil BP and observed for 14 days. The animal exhibited no mortality, no signs of cystemic toxicity, expected gains in bodyweight, no abnormalities at necropsy.

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no effects were observed at the highest dose tested, 2000 mg/kg bw

Mortality:

No deaths observed

Clinical signs:

No signs of systemic toxicity were noted

Body weight:

All animals showed expected gains in bodyweight over the observation period (see Table 5)

Gross pathology:

No abnormalities were noted at necropsy.

Other findings:

Not applicable

Any other information on results incl. tables

Table 5. Individual bodyweights and bodyweight changes.

 

Dose level, mg/kg	Animal number and sex	Bodyweight (g) at Day			Bodyweight gain (g) during week
		0	7	14	1	2
2000	2-0 Female	169	181	193	12	12
	3-0 Female	176	189	199	13	10
	3-1 Female	170	186	199	16	13
	3-2 Female	194	210	230	16	20
	3-3 Female	176	200	216	24	16

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

CLP Implementation.

Conclusions:

The acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight.

Executive summary:

Study Summary:

Introduction. The study was performed to assess the acute oral toxicity of the test material in the Wistar strain rat. The method was designed to meet the requirements of the following:

- OECD Guideline for Testing of Chemicals No 420 “Acute oral toxicity – fixed dose method” (adopted 17 December 2001)

- Method B1 bis Acute toxicity (oral) of Commission Regulation (EC) No. 440/2008

 

Method. Following a sighting test at dose levels of 300 and 2000 mg/kg, a further group of four fasted female animals were given a single oral dose of undilted test material at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

 

Morality. There were no deaths.

 

Clinical Observations. There were no signs of systemic toxicity ntoed.

 

Bodyweight. All animals showed expected gains in bodyweight.

 

Necropsy. No abnormalities were noted at necropsy.

 

Conclusion. The acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight.