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Diss Factsheets

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:
24 April 1990 - 5 June 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of dipotassium 3,3'-sulphonylbis(benzenesulphonate) and potassium 3-(phenylsulphonyl)benzenesulphonate
EC Number:
915-932-1
Molecular formula:
Reaction mass of C12H8O8S3.2K and C12H9O5S2.K
IUPAC Name:
Reaction mass of dipotassium 3,3'-sulphonylbis(benzenesulphonate) and potassium 3-(phenylsulphonyl)benzenesulphonate
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
Test substance: Additive VP KU 1-1909
Lot#: DZA-UER -8919598-A
Manufacturer: Bayer AG, Leverkusen
Purity: 86.5% (see annex, appendix.3)
Identity/Stability: guaranteed for the study period
Storage: room temp, darkness
CAS #: 63316-43-8
Molecular weight: 336 g/mol

Test animals

Species:
rabbit
Strain:
other: Albino HC:NZW
Details on test animals or test system and environmental conditions:
Prior to the individually housed in stainless steel cages with perforated bases, uder standardized conventional coditions. Excrement trays beneath the cages contained low-dust (wood) bedding. Bedding was regularly spot checked for contaminants at the instance of the Department of Laboratory Animal Services, and changed at leased twice weekly.
Room temp: 20 +/- 3 Celsius
Humidity: 50%
Light/Dark cycle: 12h, artificial illumination
Air exchange rate: ~10 times per hour

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
500 4mg
Duration of treatment / exposure:
4 hours
Observation period:
24, 48, and 71 hours
Number of animals:
3
Details on study design:
The treated skin area was aprox 6 cm^2 in size. After an exposure period of 4 hours, the dressing and patches were removed. The exposed skin areas were carefully washed with water without altering the existing response, or the integrity of the epidermis. The contrlateral skin area not treated with test substance served as control. DRAIZE scores were recorded approximately 24, 48, and 72 hours after application of the test substance.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not Applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not Applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not Applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not Applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not Applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other:
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The substance is non-irritating to skin.

Any other information on results incl. tables

No irritation (erythema, escar, oedema) was observed at any time period for any animal tested.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item was considered not to be irritating to the skin.
Executive summary:

In a GLP OECD 404 guideline study, 500mg of the substance was tested on three rabbits. All test subjects showed no signs of skin irritation and the substance can therefore be regarded as non-irritating to skin.