Ethyldimethyl[2-[(2-methyl-1-oxoallyl)oxy]ethyl]ammonium ethyl sulphate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

January 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Test material form:

liquid

Details on test material:

METHACRYLOYLDIMETHYLETHYLAMMONIUMETHYLSULFATE, 39 .6% AQUEOUS FORMULATION

SUBSTANCE NUMBER: 94/521

LOT NUMBER: PARTIE 7/94

DATE OF MANUFACTURING: 10-SEP-1994

PHYSICAL STATE/APPEARANCE : LIQUID, ACHROMATIC

Specific details on test material used for the study:

METHACRYLOYLDIMETHYLETHYLAMMONIUMETHYLSULFATE, 39 .6% AQUEOUS FORMULATION

SUBSTANCE NUMBER: 94/521

LOT NUMBER: PARTIE 7/94

DATE OF MANUFACTURING: 10-SEP-1994

PHYSICAL STATE/APPEARANCE : LIQUID, ACHROMATIC

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

ANIMAL SPECIES: RABBIT / WHITE NEW ZEALAND (SPF)

ANIMAL SUPPLIER: DR. K. THOMAE GMBH, BIBERACH, FRG

AGE OF THE ANIMALS: YOUNG ADULT ANIMALS

ANIMAL IDENTIFICATION: EAR TATTOO

ROOM TEMPERATURE/ RELATIVE HUMIDITY: THE ANIMALS WERE HOUSED IN FULLY AIR-CONDITIONED ROOMS. CENTRAL AIR-CONDITIONING GUARANTEED A RAN­ GE OF 20 - 24 DEGREES CELSIUS FOR TEMPERATURE AND OF 30 - 70 % FOR RELATIVE HUMIDITY.THERE WERE NO DEVIATIONS FROM THESE RANGES WHICH INFLUENCED THE RESULTS OF THE STUDY.

DAY/NIGHT RHYTHM: 12 H/12 H (6.00 A.M. - 6.00 P.M./ 6.00 P.M. - 6.00 A.M. )

TYPE OF CAGE: STAINLESS STEEL WIRE MESH CAGES WITH GRATING, FLOOR AREA : 3000 CM2

NO. OF ANIMALS PER CAGE: SINGLE HOUSING

BEDDING: NO BEDDING IN THE CAGES; SAWDUST IN THE WASTE TRAYS

DRINKING WATER: ABOUT 250 ML TAP WATER PER ANIMAL PER DAY

DIET: KLIBA-LABORDIAET 341, KLINGENTALMUEHLE AG KAISERAUGST, SWITZERLAND (ABOUT 130 G PER ANIMAL PER DAY)

ANALYSIS OF DRINKING WATER: THE DRINKING WATER IS REGULARLY ASSAYED FOR CHEMICAL CONTAMINANTS BY THE MUNICIPAL AUTHORI­ TIES OF FRANKENTHAL ANO THE TECHNICAL SERVICES OF BASF AKTIENGESELLS CHAFT AS WELL AS FOR THE PRESENCE OF GERMS BY A CONTRACT LABORATORY.

ANALYSIS OF FEED: THE FEED USED IN THE STUDY WAS ASSAYED FOR CHEMICAL ANO MICROBIOLOGICAL CONTAMINANTS.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

Total quantity applied: 0.5 ml

Duration of treatment / exposure:

4 hours

Observation period:

1h, 24 h, 48 h and 72 hours after the patch removal.

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: dorsal/flank area
- Type of wrap if used: The test substance has been covered with a test patch and Fixomull stretch adhesive fleece.

REMOVAL OF TEST SUBSTANCE: residual is wiped with a cotton wool soaked in water.

SCORING SYSTEM: Draize's score

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 72 hours

Score:

0.1

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 72 hours

Score:

0

Max. score:

0

Reversibility:

other: no effect observed

Irritant / corrosive response data:

In the first 24 hours only erythema was observed and in only 1 animal (score = 1). Subsequently no effects were observed.

Other effects:

None.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the test, MADQUAT DES is not irritating to the skin of the rabbit.