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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable well documented report which meets basic scientific principles.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982
Reference Type:
secondary source
Title:
SIDS Initial Assessment Report For SIAM 21
Author:
OECD
Year:
2007
Bibliographic source:
OECD SIDS

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
Principles of method if other than guideline:
The procedure used is based, but not in every part identical with the Proposed Guidelines of the United States Environmental Protection Agency (EPA) Paragraph 163.81-5 "Primary eye irritation study".
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Disodium 4,4'-bis[(4-anilino-6-morpholino-1,3,5-triazin-2-yl)amino]stilbene-2,2'-disulphonate
EC Number:
240-245-2
EC Name:
Disodium 4,4'-bis[(4-anilino-6-morpholino-1,3,5-triazin-2-yl)amino]stilbene-2,2'-disulphonate
Cas Number:
16090-02-1
IUPAC Name:
disodium 2,2'-ethene-1,2-diylbis{5-[(4-anilino-6-morpholin-4-yl-1,3,5-triazin-2-yl)amino]benzenesulfonate}
Details on test material:
- Name of test material (as cited in study report): FAT 65'023/L
- Physical state: powder
- Analytical purity: active substance content 83%,
- Lot/batch No.: EN 20
- Stability under test conditions: not determined

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Weight at study initiation: 2-3 kg
- Housing: individually in metal cages.
- Diet: Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland), ad libitum
- Water: water ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3 °C
- Humidity (%): 55±15 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye was not treated and served as an untreated control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
- Concentration (if solution): undiluted

Duration of treatment / exposure:
single exposure; in 3 of the 6 rabbits approximately 30 seconds after the treatment the treated eye was washed out
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with 10 ml of sterile physiological saline.
- Time after start of exposure: In 3 of the 6 rabbits approximately 30 seconds after the treatment the treated eye was flushed with 10 ml of sterile physiological saline.


TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
rinsed and unrinsed eyes
Time point:
other: 24 h - 48 h - 72 h
Score:
0
Max. score:
4
Reversibility:
other: no reactions
Irritation parameter:
iris score
Basis:
mean
Remarks:
rinsed and unrinsed eyes
Time point:
other: 24 h - 48 h - 72 h
Score:
0
Max. score:
2
Reversibility:
other: no reactions
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
unrinsed eyes
Time point:
other: 24 h - 48 h - 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
rinsed eyes
Time point:
other: 24 h - 48 h - 72 h
Score:
0.1
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
unrinsed eyes
Time point:
other: 24 h - 48 h - 72 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
rinsed eyes
Time point:
other: 24 h - 48 h - 72 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 48 h

Any other information on results incl. tables

Findings animal 1/2/3 (undiluted test substance, eyes not washed out):

 Time   Opacity Iritis  Erythema  Chemosis                  
24 h 0/0/0 0/0/0 0/1/1 1/0/0                  
48 h

0/0/0

  0/0/0 0/1/0 0/0/0                  
72 h 0/0/0  0/0/0 0/0/0 0/0/0                  
 7 d 0/0/0  0/0/0 0/0/0 0/0/0                  
 Mean: 24h - 48h - 72h 0/0/0  0/0/0 0/0.7/0.3 0.3/0/0                  

Findings animal 4/5/6 (undiluted test substance, eyes washed out):

 Time   Opacity Iritis    Erythema Chemosis                  
24 h 0/0/0  0/0/0 1/0/0 0/0/1                  
48 h

0/0/0

  0/0/0 0/0/0 0/0/0                  
72 h 0/0/0  0/0/0 0/0/0 0/0/0                  
 7 d 0/0/0  0/0/0 0/0/0 0/0/0                  
 Mean: 24h - 48h - 72h 0/0/0 0/0/0 0.3/0/0 0/0/0.3                  

FAT 65'023/L was found to cause mild irritation when applied to the rabbit eye mucosa.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is not irritant to eyes.