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Toxicological information

Skin irritation / corrosion

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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

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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hours
Score:
0.1
Max. score:
1
Reversibility:
fully reversible within: 48 hours
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.