Oils, fish, sulfated, sodium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

other: Read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

From 21 April 2010 - 18 May 2010

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Read Across from a GLP well conducted study on the supporting structural related substance

Justification for type of information:

The justification for the use of the similar substance is detailed in the Read Across document attached in section 13

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Oils, fish, oxidized, bisulfited, sodium salts

EC Number:

307-037-4

EC Name:

Oils, fish, oxidized, bisulfited, sodium salts

Cas Number:

97488-98-7

Molecular formula:

Not applicable, UVCB

IUPAC Name:

Oils, fish, oxidized, bisulfited, sodium salts

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report): FLL Sample 3
- Physical state: viscous liquid
- Purity: 90%
- Lot/batch No.: LS06921
- Expiration date of the lot/batch: 13 October 2010
- Storage condition of test material: room temperature, in the dark
- Other: amber coloured

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:

2000 mg/kg

No. of animals per sex per dose:

5

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:

A sighting study with one animal given a single oral gavage dose of 2000 mg/kg bw showed no signs of toxicity after 14 days of observation. Four additional animals were treated at this dose level for the main study.

Effect levels

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:

other: Hunched posture was noted in all animals during the day of dosing. Animals appeared normal four hours or one day after dosing.

Gross pathology:

No abnormalities were noted at necropsy.

Other findings:

Not applicable

Any other information on results incl. tables

Table 2. 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	1-0 Female	186	200	216	14	16
	2-0 Female	173	189	196	16	7
	2-1 Female	186	214	219	28	5
	2-2 Female	178	189	202	11	13
	2-3 Female	173	195	217	22	22

 

 

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information according to CLP Criteria used for interpretation of results: EU

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:

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 a dose level of 2000 mg/kg, an additional four fasted female animals were given a single oral dose of test material, as a suspension in distilled water, 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.

 

Mortality. There were no deaths.

 

Clinical Observations. Hunched posture was noted in all animals during the day of dosing. Animals appeared normal four hours or one day after dosing.

 

Bodyweight. All animals showed expected gains in bodyweight.

 

Necropsy. No abnormalities were noted at necropsy.