Fatty acids, vegetable-oil, sulfated, sodium salts

Endpoint summary

Description of key information

No concern for acute toxicity regarding oral and dermal exposure routes

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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:

other: GLP Guideline Study (OECD 420, EC B.1 bis)

Justification for data waiving:

other:

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

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

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

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

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.

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: No signs of systemic toxicity were noted

Gross pathology:

No abnormalities were noted at necropsy.

Other findings:

Not applicable

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

 

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information: GHCS system

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 (Globally Harmonised Classification System - unclassified).

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 (Globally Harmonised Classification System – Unclassified).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Only preliminary results are available at present time.

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: HsdRccHan(TM)WIST

Sex:

male/female

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Duration of exposure:

24 hours

No. of animals per sex per dose:

5 males and 5 females

Control animals:

other: no information at that time

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

males: 0/5
females: 0/5

Interpretation of results:

other: does not trigger criteria for toxicity classification

Remarks:

Criteria used for interpretation of results: other: CLP

Conclusions:

The dermal median lethal dose was > 2000 mg/kg for acute (24-hour) exposure for rat. This does not classify the substance under the CLP regulation.

Executive summary:

Not available yet (preliminary results)

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

Acute oral exposure data are available for the sodium salt of sulphated castor oil. No toxicity was observed in a 1984 EC guideline study with rats at a single dose of 15,600 mg/kg bw. Read across from similar substances (sulfited fat liquors EC 307-037-4 fish oil and EC 281-975-1 rape oil) indicate the substances have low acute toxicity. The more conservative 2000 mg/kg bw no effect levels from the more extensive read across studies was used as the starting point to derive DNELs for the sulfated fat liquors.

Justification for selection of acute toxicity – oral endpoint
No data on the substance are available. The result of the testing on acute toxicity performed on the analogous sulphited vegetable oils sodium salt has been considered as read across

Justification for selection of acute toxicity – dermal endpoint
No data on the substance are available. The result of the testing on acute toxicity performed on the analogous sulphited vegetable oils sodium salt has been considered as read across

Justification for classification or non-classification

The substance is not considered dangerous for acute toxicity following CLP criteria set out in the Regulation 1272/2008