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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
Deviations:
not specified
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetrasodium [μ-[[3,3'-[azoxybis[(2-hydroxy-p-phenylene)azo]]bis[4-hydroxy-6-(3-sulphoanilino)naphthalene-2-sulphonato]](8-)]]dicuprate(4-)
EC Number:
250-792-9
EC Name:
Tetrasodium [μ-[[3,3'-[azoxybis[(2-hydroxy-p-phenylene)azo]]bis[4-hydroxy-6-(3-sulphoanilino)naphthalene-2-sulphonato]](8-)]]dicuprate(4-)
Cas Number:
31765-95-4
Molecular formula:
C44H24Cu2N8O17S4.4Na
IUPAC Name:
tetrasodium [μ-[[3,3'-[azoxybis[(2-hydroxy-p-phenylene)azo]]bis[4-hydroxy-6-(3-sulphoanilino)naphthalene-2-sulphonato]](8-)]]dicuprate(4-)
additive 1
Chemical structure
Reference substance name:
Sodium sulphate
EC Number:
231-820-9
EC Name:
Sodium sulphate
Cas Number:
7757-82-6
Molecular formula:
H2O4S.2Na
IUPAC Name:
disodium sulfate
Test material form:
solid: particulate/powder
Details on test material:
0.9 % Spolostan 4P1.6 % SireneX12-L
Specific details on test material used for the study:
Saturnová šeď LCG: 95.2 % (w/w)black powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS - Source: Spolek chovatelů Hradec Králové, Czech Republic - Weight at study initiation: > 2.5 kg - Housing: individual cages without bedding, monitored conditions - Diet (e.g. ad libitum): standard granular feed (for rabbits and guinea pigs) ad libitum - Water (e.g. ad libitum): tap water ad libitum ENVIRONMENTAL CONDITIONS - Temperature (°C): 20 ± 2°C - Humidity (%): 40 - 70 % - Photoperiod (hrs dark / hrs light): 12 hrs light / 12 hrs dark

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.1 g of the test substance
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 animals
Details on study design:
REMOVAL OF TEST SUBSTANCE - Washing (if done): yes - Time after start of exposure: 24 hours SCORING SYSTEM: According to OECD Guidelinr 405 TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0 - 1
Max. score:
3
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: average score: 0.667
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0 - 1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: average score: 0.333
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0 - 2
Max. score:
3
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: average score: 1.000
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0 - 1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: average score: 0.333
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0 - 2
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: average score: 0.333
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1 - 2
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: average score: 1.667
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1 - 2
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: average score: 1.667

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance, Direct Black 112, is not irritant to eyes according to conditions listed in Regulation (EC) 1272/2008 (CLP).