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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
eye 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 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
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 / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Madorin AG, Fullingsdorf, Schweiz
- Age at study initiation: about 3 - 5 months
- Weight at study initiation: 2.8 - 3.0 kg
- Housing: single cages in fully air conditioned rooms
- Diet: Altromin 2123 ad libitum and 15 g hay per day
- Water: deionized and dechlorinated tap water ad libitum

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

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated right eye of the animal
Amount / concentration applied:
100 mg test subtance in the left eye of the animal
Duration of treatment / exposure:
24 hours
Number of animals or in vitro replicates:
72 hours
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: physiolog. NaCl-solution
- Time after start of exposure: 24 hours

SCORING SYSTEM:
cornea: 0 - 4
iris: 0 - 2
conjunctivae: 0 - 3
chemosis: 0 - 4

TOOL USED TO ASSESS SCORE: fluorescein, UV light

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 h
Score:
1.66
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 48 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 h
Score:
0.66
Max. score:
2
Reversibility:
fully reversible within: 24 h
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
2
Irritation parameter:
cornea opacity 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 has not to be classified as eye irritating.
Executive summary:

The substance was testes for eye irritation according to OECD guideline 405 with 3 Albino New Zealand Rabbits. 100 mg of the substance were administered into the left eye of each animal. Some animals showed a sligt redness and swelling of the conjunctivae. But these signs were fully reversible at the latest after 48 hours.