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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well performed GLP and OECD guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

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-5-methoxy-N,2-dimethylbenzenesulphonamide
EC Number:
256-380-5
EC Name:
4-amino-5-methoxy-N,2-dimethylbenzenesulphonamide
Cas Number:
49564-57-0
Molecular formula:
C9H14N2O3S
IUPAC Name:
4-amino-5-methoxy-N,2-dimethylbenzene-1-sulfonamide
Details on test material:
- Name of test material (as cited in study report): Kresidinsulfmethylamid TF 9

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG breeding colony
- Age at study initiation: about 3 - 5 months
- Weight at study initiation: 1.9 - 3.0 kg
- Housing: air conditioned rooms in single cages
- Diet: Altromin 2123 and hay ad libitum
- Water: tap water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+-3
- Humidity (%): 50+-20
- Photoperiod: 12 hrs dark / 12 hrs light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
physiological saline
Controls:
no
Amount / concentration applied:
500 mg of the test item mixed with 0.5 ml of a 0.9% NaCl-solution
Duration of treatment / exposure:
4 hours
residual test substanced was removed with lukewarm tap water at the end of the exposure period
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: cellulose patch fixed with a plaster

REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm 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:
animal: # 64 and 96 each
Time point:
other: mean of 24, 48, and 72 h
Score:
0
Max. score:
4
Reversibility:
other: no signs if irrtation (erythema) at any time
Irritation parameter:
erythema score
Basis:
animal: # 95
Time point:
other: mean of 24, 48, and 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
animal: # 64, 95, 96 each
Time point:
other: mean of 24, 48, and 72 h
Score:
0
Max. score:
4
Reversibility:
other: no signs of irritation (edema) at any time
Other effects:
no other effects reported

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
not irritating to skin
Executive summary:

The test item was tested for dermal irritation/corrosion in rabbits according to OECD 404. 500 mg of the test item pasted with physiol. saline were applied to the clipped dorsal skin of 3 rabbits for 4 hours under semiocclusive conditions. Thereafter the residual test item was removed using lukewarm tap water. Mean scores for edema and erythema were calculated (24, 48, and 72 hours reading) for each rabbit.

Based on the findings the test substance was considered not to be a skin irritant.