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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Eye irritation

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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: non-GLP study, but according to OECD guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
1984
Deviations:
no
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Hexasodium 4,4'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-morpholino-1,3,5-triazine-4,2-diyl]imino]]bis[5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate]
EC Number:
241-769-4
EC Name:
Hexasodium 4,4'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-morpholino-1,3,5-triazine-4,2-diyl]imino]]bis[5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate]
Cas Number:
17791-81-0
Molecular formula:
C60 H46 N16 Na6 O22 S6
IUPAC Name:
4,4'-[1,2-ethenediylbis[(3-sulfo-4,1-phenylene)imino[6-(4-morpholinyl)-1,3,5-triazine-4,2-diyl]imino]]bis[5-hydroxy-6-(2-phenyldiazenyl)-2,7-naphthalenedisulfonic acid] hexasodium salt
Test material form:
not specified

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wölferstrasse 4, CH-4414 Füllinsdorf
- Age at study initiation: 1 male, 2 females
- Weight at study initiation: male : 3.0 kg, females: 2.7 - 2.9 kg
- Housing: Individually in stainless steel cages (35.5 x 55.5 x 45 cm)
- Diet: Pelleted standard Kliba 341, Batch 62/91 rabbit maintenance diet ("Kliba", Klingentalmühle AG, CH-4303 Kaiseraugst), ad libitum
- Water: Community tap water from Itingen, ad libitum
- Acclimation period: four days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 40 -70
- Air changes (per hr): 10 -15
- Photoperiod (hrs dark / hrs light): 12/12 (music during the light period

Test system

Vehicle:
not specified
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied : 0.1 g


Duration of treatment / exposure:
The eyelids were held together for about one second. The test substance was not washed out.
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
1 male
2 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM: according to the OECD score system

TOOL USED TO ASSESS SCORE: hand-slit lamp 30 SL/M (C. Zeiss AG, Zuerich /Switzerland) and a Varta Cliptrix diagnostic-lamp (A. Riegger, Basel /Switzerland)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0
Max. score:
4
Remarks on result:
other: not rinsed
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24 h/ 48 h/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: not rinsed
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24 h/48 h/72 h
Score:
0
Max. score:
4
Remarks on result:
other: not rinsed
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24 h/48 h/ 72 h
Score:
0
Max. score:
2
Remarks on result:
other: not rinsed
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0
Max. score:
2
Remarks on result:
other: not rinsed
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0
Max. score:
2
Remarks on result:
other: not rinsed
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24 h/ 48 h/ 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 21 days
Remarks on result:
other: not rinsed
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24 h/ 48 h/ 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: not rinsed
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24 h/ 48 h/ 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 21 days
Remarks on result:
other: not rinsed
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0
Max. score:
4
Remarks on result:
other: not rinsed
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: not rinsed
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24 h/ 48 h/ 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: not rinsed

Any other information on results incl. tables

No necropsy was performed in the animals euthanized at termination of observation. No acute clinical symptoms were observed in the animals during the test and observation period, and no mortality occured. The body weight gain of all rabbits was similar.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU