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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1982
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:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Principles of method if other than guideline:
occlusive dressing
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
4-amino-2,5-dichloro-N,N-dimethylbenzenesulphonamide
EC Number:
247-501-2
EC Name:
4-amino-2,5-dichloro-N,N-dimethylbenzenesulphonamide
Cas Number:
26175-68-8
Molecular formula:
C8H10Cl2N2O2S
IUPAC Name:
4-amino-2,5-dichloro-N,N-dimethylbenzene-1-sulfonamide
Details on test material:
- Name of test material (as cited in study report): 1-Amino-2,5-dichlorbenzol-4-sulfonsaeure-dimethylamid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoering AG, 4414 Fuellinsdorf, Switzerland
- Age at study initiation: approx. 12 weeks
- Weight at study initiation: 2.3 - 3.0 kg
- Housing: individually in stainless steel cages with automatic drinking water supply and cleaning system
- Diet: pelleted standard Kliba 341, rabbit maintenance diet ad libitum
- Water: tap water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-2
- Humidity (%): 55+-10
- Photoperiod : Light cycle 12 hours/day

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: Polyethyleneglycol / Saline = 7 / 3
Controls:
no
Amount / concentration applied:
The test material was applied under a patch of filter paper approx. 3 cm x 3 cm. 1 g of a 50% suspension of the test substance diluted with polyethyleneglyol/saline (7/3) was used. When the patch was in place it was covered with impermeable material and fastened to the body with adhesive tape.
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 (1 male, 2 females)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: # 140, 141, 142 each
Time point:
other: mean of 24, 48, and 72 h
Score:
0
Max. score:
4
Reversibility:
other: no signs of irritation (erythema) at any time
Irritation parameter:
edema score
Basis:
animal: # 140, 141, 142 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
Irritant / corrosive response data:
no signs of irritation or corrosion at any time
Other effects:
NO ACUTE TOXICOLOGICAL SIGNS WERE OBSERVED IN THE ANIMALS DURING THE TEST PERIOD.

Applicant's summary and conclusion

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

When testing for acute dermal irritation/corrosion in rabbits according to OECD 404 the test substance showed no signs of irritation (all scores 0). No destructions or irreversible alterations of the treated skin were observed. Thus it was concluded that the test substance is not irritating and not corrosive to skin.