Fatty acids, C12-18 (even numbered)-methyl esters, sulfonated, sodium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11th January - 21st February, 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

Commission Directive 92/69/EEC

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C12-18, α-sulfo, 1-Me esters, sodium salts

EC Number:

288-224-7

EC Name:

Fatty acids, C12-18, α-sulfo, 1-Me esters, sodium salts

Cas Number:

85681-86-3

Molecular formula:

C13H25NaO5S - C19H37NaO5S

IUPAC Name:

Fatty acids, C12-18, α-sulfo, 1-Me esters, sodium salts

Constituent 2

Reference substance name:

Fatty acids, C12-18, α-sulfo, disodium salts

EC Number:

286-085-7

EC Name:

Fatty acids, C12-18, α-sulfo, disodium salts

Cas Number:

85186-99-8

Molecular formula:

C12H22Na2O5S - C18H34Na2O5S

IUPAC Name:

Fatty acids, C12-18,α-sulfo, disodium salts

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan UK Ltd, Blackthorn, Bicester, Oxon, UK
- Females (if applicable) nulliparous and non-pregnant: No data
- Age at study initiation: 5-8 weeks old
- Weight at study initiation: males 134-148g; females 124-132 g.
- Fasting period before study: Overnight fast immediately before dosing
- Housing: Housed in groups of up to five by sex in solid floor polypropylene cages furnished with woodflakes.
- Diet: ad libitum from 2 hours after dosing. Rat and Mouse Expanded Diet No. 1,
- Water: ad libitum from 2 hours after dosing
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22
- Humidity (%): 38-69
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

DMSO

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): No data
- Justification for choice of vehicle: No data
- Lot/batch no. (if required): No data
- Purity: No data

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

DOSAGE PREPARATION (if unusual):The test material was ground to a fine powder using a mortar and pestle and freshly prepared, as required, as a solution/suspension at the appropriate concentration in DMSO. Homogeneity was assured by the use of a Silverson Homogeniser.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Not applicable

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for deaths or overt signs of toxicity 1/2, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days. Individual bodywieghts were recorded prior to dosing on Day 0 and on Days 7 and 14 or at death.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology (external examination and opening of the abdominal and thoracic cavities).

Statistics:

Not stated

Results and discussion

Preliminary study:

The female was found dead one day after dosing. No clinical signs of toxicity were noted.
Based on this information, a dose level of 2000 mg/kg bw was selected for the main study.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable

Mortality:

Two females were found dead one day after dosing.

Clinical signs:

other: Common signs of systemic toxicity noted were hunched posture, lethargy, decreased respiratory rate and laboured respiration with additional signs of noisy respiration and increased salivation. Surviving animals recovered two to four days after dosing.

Gross pathology:

Abnormalities noted at necropsy of the females that died during the study were haemorrhagic lungs, dark liver, dark kidneys, haemorrhage of the gastric mucosa and hamorrhage fo the small and large intestines. Sloughing of the gastric mucosa was noted at necropsy of one male and one female that were killed at the end of the study. No abnormalities were noted at necropsy of all other animals that were killed at the end of the study.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of the test item was > 2000 mg/kg bw.

Executive summary:

The acute oral toxicity of the test item was assessed in a study performed according to OECD TG 401 and Method B.1 of Commission Dreictive 67/548/EEC using Sprague-Dawley rats. In a preliminary test, 2 rats (one male/one female) were dosed by gavage at 2000 mg/kg bw. The female was found dead one day after dosing. No clinical signs of toxicity were noted. Based on this information, a dose level of 2000 mg/kg bw was selected for the main study. Based on the results of this test, rats (5 males and 5 females) were dosed by gavage at 2000 mg/kg bw/day and observed for 14 days. Two females were found dead one day after dosing. No further deaths were recorded. Common signs of systemic toxicity noted were hunched posture, lethargy, decreased respiratory rate and laboured respiration with additional signs of noisy respiration and increased salivation. Surviving animals recovered two to four days after dosing. Surviving animals showed expected bodyweight gain during the study. Abnormalities noted at necropsy of the females that died during the study were haemorrhagic lungs, dark liver, dark kidneys, haemorrhage of the gastric mucosa and hamorrhage of the small and large intestines. Sloughing of the gastric mucosa was noted at necropsy of one male and one female that were killed at the end of the study. No abnormalities were noted at necropsy of all other animals that were killed at the end of the study. Based on the results of this study, the oral LD50 was determined to be >2000 mg/kg bw.