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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test performed before OECD and GLP guidelines. Important aspects are in line with current OECD guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
1975

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: FDA-guideline, Federal Register, Vol. 38, No. 187, 1973
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: company guideline simila to OECD 405
Deviations:
no
GLP compliance:
no
Remarks:
prior to GLP implementation

Test material

Constituent 1
Chemical structure
Reference substance name:
4-amino-2,5-dimethoxy-N-phenylbenzenesulphonamide
EC Number:
257-821-4
EC Name:
4-amino-2,5-dimethoxy-N-phenylbenzenesulphonamide
Cas Number:
52298-44-9
Molecular formula:
C14H16N2O4S
IUPAC Name:
4-amino-2,5-dimethoxy-N-phenylbenzene-1-sulfonamide
Details on test material:
- Name of test material (as cited in study report): Chinonbasesulfanilid

Test animals / tissue source

Species:
rabbit
Strain:
other: SPF-Albino-Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.5 - 2.0 kg
- Housing: single cage
- Diet: ERKA 8300, Futterwerke Robert Koch oHG/Hamm, ad libitum
- Water : tap water, ad libitum

ENVIRONMENTAL CONDITIONS: no data

Test system

Vehicle:
other: unchanged (no vehicle), or 10% dilution in sesame oil
Controls:
other: untreated eye of the test animal
Amount / concentration applied:
a) 100 mg unchanged substance without vehicle
b) 0.1 ml of a 10% dilution of the substance in sesame oil
Duration of treatment / exposure:
Duration of treatment was 24 h. Eyes were rinsed with phsiol. saline after the first examination (24 after instillation).
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
6 for the unchanged (no vehicle) substance and 6 for the 10% dilution
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing : physiologic NaCl-solution
- Time after start of exposure: 24 h (= after the first examination)

TOOL USED TO ASSESS SCORE: hand-slit lamp / binocular / fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: # 50, 21, 72, 20, 78, 51 each
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no signs of irritation (cornea) at any time
Remarks on result:
other: unchanged (no vehicle)
Irritation parameter:
iris score
Basis:
animal: # 50, 21, 72, 20, 78, 51 each
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
2
Reversibility:
other: no signs of irritation (iris) at any time
Remarks on result:
other: unchanged (no vehicle)
Irritation parameter:
conjunctivae score
Basis:
animal: # 51
Time point:
other: mean of 24, 48, 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: unchanged (no vehicle)
Irritation parameter:
conjunctivae score
Basis:
other: # 50,72, 78 each
Time point:
other: mean of 24, 48, 72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: unchanged (no vehicle)
Irritation parameter:
conjunctivae score
Basis:
animal: # 21, 20 each
Time point:
other: mean of 24, 48, 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: unchanged (no vehicle)
Irritation parameter:
chemosis score
Basis:
animal: # 50, 21, 72, 20, 78, 51 each
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no signs of irritation (chemosis) at any time
Remarks on result:
other: unchanged (no vehicle)
Irritant / corrosive response data:
All mean scores calculated for the 10% dilution are 0
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:
Based on the findings in this test the unchanged test substance and its 10% dilution are not eye-irritating.
Executive summary:

Chinonbasesulfanilid was tested for eye irritating properties according to FDA-guideline (Federal Register, Vol. 38, No. 187, 1973) which is similar to OECD 405. Following this protocol 100 mg of the undiluted test substance (or a 10% dilution) were applied into the conjunctival sac of one eye from each of six rabbits. The other eye remained untreted and served as control. After 24 h exposure time the eyes were rinsed with physiol. saline. The eyes of the animals were examined at 1, 7, 24, 48, 72 h, and 7, 14 days after test substance application. Mean scores (mean of 24, 48, 72 h) were calculated for cornea, iris, conjunctivae redness, and conjunctivae chemosis for each animal.

Based on the findings in this test the unchanged test substance and its 10% dilution are not eye-irritating.