Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well performed OECD study with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Ammonium 4-acetoacetylamino-5-methoxy-2-methylbenzenesulphonate
EC Number:
276-769-3
EC Name:
Ammonium 4-acetoacetylamino-5-methoxy-2-methylbenzenesulphonate
Cas Number:
72705-22-7
Molecular formula:
C12H15NO6S.H3N
IUPAC Name:
ammonium 4-acetoacetylamino-5-methoxy-2-methylbenzenesulphonate
Details on test material:
purity: 90% contains residual water

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breeding
- Weight at study initiation: 2.5 - 3.2 kg
- Housing: in single cages located in completely air-conditioned rooms
- Diet: Altromin 2013 Zuchtdiät - Kaninchen (Altromin GmbH, Lage/Lippe), ad libitum
- Water: deionized and chlorinated water from automatic dispensors, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+-2
- Humidity (%): 55+-10
- Photoperiod: 12 hrs dark / 12 hrs light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
abraded
Vehicle:
physiological saline
Controls:
no
Amount / concentration applied:
500 mg substance suspended with 0.5 ml 0.9% NaCl-solution
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- % coverage: 100
- Type of wrap if used: plaster and semi-occlusive bandage

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 hours

SCORING SYSTEM (according to DRAIZE):
erythema: 0 - 4 ; edema: 0 - 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 1 day
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 h
Score:
0
Max. score:
4

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this test the substance is considered to be not irritating to the skin
Executive summary:

The substance was tested for skin irritation at 3 albino New Zealand rabbits according to OECD guideline 404. 500 mg of the substance suspended in 0.5 ml saline solution was applied with a plaster on 2.5 cm x 2.5 cm of the abraded skin of the rabbits and fixed with a semi-occlusive bandage. After 4 hours the substance was removed and the erythema and edema scores were evaluated according to the Draize system. 0.5 hours after removal of the batch one animal showed redness and swelling, but these signs disappeared within 24 hours. All other animals were free from signs.