Magnesium bis(dinonylnaphthalenesulphonate)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion, other

Remarks:

Existing in-vivo study

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November 23 - 26, 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: non-GLP, test with formulation, limited information on results (no individual data, only 2 observations), The exposure during 24 hours represents a worst case. The information in the report is limited to the information in the summary.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

see below

Principles of method if other than guideline:

6 animals were treated. Exposure period was 24 hours under occlusion. Observations were done at 24 and 72 hours.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Magnesium bis(dinonylnaphthalenesulphonate)

EC Number:

248-777-7

EC Name:

Magnesium bis(dinonylnaphthalenesulphonate)

Cas Number:

28015-99-8

Molecular formula:

Mg[C28H43O3S]2

IUPAC Name:

magnesium bis(dinonylnaphthalenesulphonate)

Test material form:

liquid: viscous

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Cedar Knolls Farm
- Age at study initiation: not indicated
- Weight at study initiation: not reported
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: not reported

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22 °C
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied : 0.5 g
- Concentration (if solution): 50%

Duration of treatment / exposure:

24 hours

Observation period:

at 24 and 72 h

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm2
- Type of wrap if used: occlusive; gauze patches, wrapped with rubberized elastic cloth

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: Draize (FHSLA 16 CFR 1500)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 and 72 h

Score:

2.4

Max. score:

3.16

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other: only two observations

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 and 72 h

Score:

2

Max. score:

2.5

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other: only two observations

Other effects:

not remarkable

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance is irritating to the skin

Executive summary:

The test substance was applied on the skin of 6 rabbits for 24 hours. Observations at 24 and 72 hr indicated that the test substance is irritating to the skin.