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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15-29 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 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

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

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:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation:10 weeks old
- Weight at study initiation: males average 312 g, females average 183 g
- Fasting period before study: no
- Housing: Individually housed 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 (%): 34-60
- Air changes (per hr): approx 15x
- Photoperiod (hrs dark / hrs light): 12-12

IN-LIFE DATES: From 15 April 2010 to 29 April 2010

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: back of the animal
- % coverage: The test substance formulation was applied in an area of approx. 10% of the total body surface, i.e. approx. 25 cm² for males and 18cm² for females.
- Type of wrap if used: a surgical gauze patch (Surgy 1D), successively covered with aluminum foil and Coban elastic bandage. A piece of Micropore tape was additionally used for fixation of the bandages in females only.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): water
- Time after start of exposure: 24 hours (at removal of the patch)

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 ml/kg
- Concentration (if solution): 200 mg/ml in water
- Constant volume or concentration used: yes

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 females and 5 males

Control animals:

not required

Details on study design:

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

Statistics:

no data

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no mortality occurred

Clinical signs:

other: Chromodacryorhhoea was noted in four males and two females on Day 1. Hunched posture and piloection were noted in one female on Day 2. Scales, scabs, necrosis, general erythema, and/or scars were seen in the treated skin-area of the animals during the obs

Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the animals.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Not classified according to Regulation (EC) No. 1272/2008

Conclusions:

The dermal LD50 value of MIZULAN FL-80 in Wistar rats was established to exceed 2000mg/kg body weight.
Based on these results, MIZULAN FL-80 does not have to be classified and has no obligatory labeling requirement for acute dermal toxicity according to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations (2007) and the Regulation (EC) No 1272/2008 on classification, labeling and packaging of substances and mixtures