2-(methylamino)ethanol, compound with sulphur dioxide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

solid test substance was applied as a solution; humidity range (animal housing): 20-80 %

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Remarks:

signed 2008-04-17

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium sulphite

EC Number:

231-821-4

EC Name:

Sodium sulphite

Cas Number:

7757-83-7

IUPAC Name:

disodium sulfite

Details on test material:

- Name of test material: Natriumsulfit wasserfrei food grade (E221)/(PRD30042389); (Sodium sulfite)
- Physical state: white solid
- Analytical purity: 98.1 %
- Batch No.: 83704888Q0
- Storage stability: stable under storage conditions
- Storage condition of test material: at room temperature; under N2; protected against humidity
- Homogeneity: the test substance was homogenous by visual inspection.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, 97633 Sulzfeld, Germany
- Age at study initiation: approx. 8 weeks old (males), approx. 12 weeks old (females)
- Weight at study initiation: animals of comparable weight (±20 % of the mean weight); mean weights: 255 g (males), 218 g (females)
- Housing: individually, in fully air-conditioned rooms in Makrolon type III cages. Bedding: H 15005-29; Ssniff Spezialitäten GmbH, 59494 Soest, Germany)
- Diet: VRF1(P); SDS (Special Diets Services), 67122 Altrip, Germany
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
- Enrichment: NGM E-022; ABEDD®LAB & VET Service GmbH, 1160 Wien, Austria

ENVIRONMENTAL CONDITIONS
- Temperature: 22–26 °C
- Relative humidity: 20–80 %
- Photoperiod: 12 hours dark / 12 hours light

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: about 24 hours before administration the fur was clipped. Then a single application to the clipped epidermis (dorsal and dorsolateral parts of the trunk) was applied.
- % coverage: at least 10 % of the body surface (about 40 cm²)
- Type of wrap: covering of the application site with a semi-occlusive dressing (the bandage consisted of four layers absorbent gauze, Ph. Eur. Lohmann GmbH & Co. KG and Fixomull stretch (adhesive fleece), Beiersdorf AG, Germany) for 24 hours, afterwards removal of the dressing

REMOVAL OF TEST SUBSTANCE
- Washing: the application site was rinsed with warm water.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount applied: 10 mL/kg bw (application volume)
- Concentration: 20 g/100 mL
- Constant volume or concentration used: constant volume
- For solids, paste formed: no, a solution was used for application. The test substance preparation was produced for the application group shortly before application. The dose formulation was stirred continuously to ensure a homogeneous distribution of the test item in the vehicle.

VEHICLE: doubly distilled water

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 animals

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Body weight determination: shortly before administration (day 0), weekly thereafter and on the last day of observation
- Signs and symptoms: recording of signs and symptoms several times on the day of application, at least once each workday for the individual animals
- Scoring of skin findings: individual readings 30–60 minutes after removal of the semi-occlusive dressing (day 1), as a rule weekly thereafter and on the last day of observation
- Mortality: a check for any dead or moribund animal was made twice each workday and once on weekends and on public holidays.
- Pathology: necropsy with gross-pathology examination on the last day of the observation period after sacrifice with carbon dioxide in a chamber with increasing concentrations over time

Assessment of skin reactions: The evaluation of skin reactions was performed according to Draize JH (1959): Appraisal of the safety of chemicals in foods, drugs and cosmetics. The association of food and drug officials of the United States, Austin, Texas. Descriptions of any dermal findings not covered by this scale were recorded.

Statistics:

The means and standard deviations were calculated by using MS Excel 2003.

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: There was no mortality at the limit dose level.

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 3

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: No systemic clinical observations were noted. No local effects were observed.

Gross pathology:

No macroscopic pathologic abnormalities were noted in the animals (5 males and 5 females) examined on the last day of observation.