Reaction mass of sodium 1-methoxy-1-oxohexadecane-2-sulphonate and sodium methyl 2-sulphooctadecanoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

08-28 April 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 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 3

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 1-methoxy-1-oxohexadecane-2-sulphonate

EC Number:

223-676-0

EC Name:

Sodium 1-methoxy-1-oxohexadecane-2-sulphonate

Cas Number:

4016-24-4

Molecular formula:

There are different notations of the molecular formula, dependent on whether it is depicted as protonated or not: C17H34O5S.Na C17H33NaO5S C14H29CH(CO2CH3)SO3Na CH3(CH2)13CH(SO3Na)COOCH3

IUPAC Name:

sodium 1-methoxy-1-oxohexadecane-2-sulfonate

Constituent 2

Reference substance name:

Sodium methyl 2-sulphooctadecanoate

EC Number:

223-770-1

EC Name:

Sodium methyl 2-sulphooctadecanoate

Cas Number:

4062-78-6

Molecular formula:

There are different notations of the molecular formula, dependent on whether it is depicted as protonated or not: C19H38O5S.Na or C19H37O5S.Na CH3(CH2)15CH(SO3Na)COOCH3

IUPAC Name:

sodium methyl 2-sulphooctadecanoate

Test material form:

solid: flakes

Details on test material:

- Physical state: pale yellow flakes
- Storage condition of test material: In refrigerator (2-8 ºC) in the dark

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: 12 weeks
- Weight at study initiation: 167-203 g
- Fasting period before study: Animals were deprived of food overnight prior to dosing and until 3-4 hours after administration of the test substance. Water was available.
- Housing: Group housing of 3 animals per cage in labeled Macrolon cages (containing sterilized sawdust as bedding material and paper as cage-enrichment.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.8-21.5
- Humidity (%):34-53
- Air changes (per hr): approx 15x
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 08 April 2010 to 28 April 2010

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/ml or 30 mg/ml
- Justification for choice of vehicle: based on trail formulations

Maximal dose volume: 10 ml/kg

Doses:

2000 mg/kg
300 mg/kg

No. of animals per sex per dose:

3 animals at 2000 mg/kg
6 animals at 300 mg/kg

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:observations daily (first day: 3x), weighing weekly
- Necropsy of survivors performed: yes (all animals)
- Other examinations performed: clinical signs, body weight, macroscopic examination

Statistics:

no

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 300 - < 2 000 mg/kg bw

Based on:

test mat.

Remarks:

formulated in water

Mortality:

no mortality at 300 mg/kg
all three animals at 2000 mg/kg were found dead on Day 1

Clinical signs:

other: 2000 mg/kg: lethargy, flat and/or hunched posture, uncoordinated movements, piloerection, laboured respiration, ptosis. 300 mg/kg: hunched posture, piloerection. The animals (at 300 mg/kg) had recovered from the symptoms between Days 2 and 5.

Gross pathology:

Macroscopic post mortem examination of the animals treated at 2000 mg/kg, which were all found dead during the study, revealed dark red discolouration of the glandular mucosa of the stomach and dark red discolouration of the small intestines together with reddish contents.
Macroscopic post mortem examination of the surviving animals, which were treated at 300 mg/kg did not reveal any abnormalities

Other findings:

none

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Remarks:

Category 4 according to Regulation (EC) No 1272/2008

Conclusions:

The oral LD50 value of MIZULAN FL-80 in Wistar rats was established to be within the range of 300-2000 mg/kg body weight. According to the Regulation (EC) No 1272/2008 on classification, labeling and packaging of substances and mixtures, the test substance should be classified as Category 4 and should be labeled as H302: Harmful if swallowed.