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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
September 1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
2 instead of 3 animals
Qualifier:
according to guideline
Guideline:
other: ETAD Method
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium [(9,10-dihydro-9,10-dioxo-1,4-anthrylene)diimino]bis[ethyltoluenesulphonate]
EC Number:
280-163-4
EC Name:
Disodium [(9,10-dihydro-9,10-dioxo-1,4-anthrylene)diimino]bis[ethyltoluenesulphonate]
Cas Number:
83027-61-6
Molecular formula:
C32H28N2Na2O8S2
IUPAC Name:
Reaction mass of disodium 2-ethyl-3-({4-[(2-ethyl-6-methyl-3-sulfonatophenyl)amino]-9,10-dioxo-9,10-dihydroanthracen-1-yl}amino)-4-methylbenzene-1-sulfonate, disodium 4-ethyl-3-({4-[(2-ethyl-6-methyl-3-sulfonatophenyl)amino]-9,10-dioxo-9,10-dihydroanthracen-1-yl}amino)-2-methylbenzene-1-sulfonate and disodium 4-ethyl-3-({4-[(6-ethyl-2-methyl-3-sulfonatophenyl)amino]-9,10-dioxo-9,10-dihydroanthracen-1-yl}amino)-2-methylbenzene-1-sulfonate
Test material form:
solid: particulate/powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Single cages
- Weight at study initiation: 3-4 kg
- Sex: male/female
- Application into conjunctiva

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
50 mg/100 µl/animal
Duration of treatment / exposure:
one treatment at 0 h
Observation period (in vivo):
7 d
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: Draize score

TOOL USED TO ASSESS SCORE: biomicroscope / fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 d
Remarks on result:
probability of mild irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Redness occurred after the treatment but was fully reversible within 7 d. No signs of corrosion observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance caused a mild irritation (conjunctivae redness). All signs were fully reversible within 7 d. The substance is not classifiable according to CLP criteria.