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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1989
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:
1989
Report date:
1989

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:
4-amino-2,5-dimethoxy-N-methylbenzenesulphonamide
EC Number:
256-435-3
EC Name:
4-amino-2,5-dimethoxy-N-methylbenzenesulphonamide
Cas Number:
49701-24-8
Molecular formula:
C9H14N2O4S
IUPAC Name:
4-amino-2,5-dimethoxy-N-methylbenzene-1-sulfonamide
Details on test material:
purity: 97.8 - 98.0 %

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
- Age at study initiation: 3 - 5 month
- Weight at study initiation: 1.8 - 2.4 kg
- Housing: single cages in fully air conditioned rooms
- Diet: Altromin 2123 ad libitum and 15 g hay per day
- Water. deionized and dechlorated water from automatic dispensers (ad libitum)
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+-3
- Humidity (%): 50+-20
- Photoperiod : 12 hours light per day

Test system

Type of coverage:
semiocclusive
Preparation of test site:
abraded
Vehicle:
other: Polyethyleneglycol 400
Controls:
no
Amount / concentration applied:
500 mg test substance with 0.6 ml Polyethyleneglycol 400
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: semiocclusive bandage

REMOVAL OF TEST SUBSTANCE
- Washing: slightly warm tap water
- Time after start of exposure: 4 hours

SCORING SYSTEM:
Erythema: 0 - 4
Edema: 0 - 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 60 min
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 60 min
Score:
0
Max. score:
0

Applicant's summary and conclusion

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

The substance was tested for skin irritation according OECD guideline 404. 3 Albino New Zealand Rabbits were used. After 4 hours exposure time none of the animals showed either signs for erythema or edema.