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Reaction mass of tetrasodium 8,8'-(1E,1'E)-(4,4'-(cyclohexane-1,1-diyl)bis(4,1-phenylene))bis(diazene-2,1-diyl)bis(7-hydroxynaphthalene-1,3-disulfonate) and trisodium 7-hydroxy-8-((E)-(4-(1-(4-((E)-(1-hydroxy-4-sulfonatonaphthalen-2-yl)diazenyl)phenyl)cyclohexyl)phenyl)diazenyl)naphthalene-1,3-disulfonate
EC number: 942-692-5 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Remarks:
- The complete Read Across Approach is attached at section 13. Source study has reliability 1.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).
- GLP compliance:
- no
- Remarks:
- pre GLP
Test material
- Reference substance name:
- Similar Substance 01
- IUPAC Name:
- Similar Substance 01
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: russian breed.
- Weight at study initiation: 2.1 to 2.9 kg.
- Acclimation period: at least 8 days.
- Housing: animals were kept separately in metal cages (overall dimensions 47×32×34 cm).
- Diet: standard diet of Nafag, ad libitum.
- Water: drinking water, ad libitum.
- Health check: only rabbits showing normal ophtalamic findings were included in the test.
ENVIRONMENTAL CONDITIONS
- Temperature: 18 ± 1 °C
- Relative humidity: 55 ± 5 %
- Photoperiod: 14 hours light/day
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 g. - Duration of treatment / exposure:
- 1 minute in three animals (eyes of the remaining 3 animals were not rinsed).
- Observation period (in vivo):
- 8 days.
- Number of animals or in vitro replicates:
- 3 males and 3 females.
- Details on study design:
- APPLICATION
The test substance was introduced into the conjunctival sac of the left eye with a spatula. After application, the eyelids were held open for a few seconds. The right eye was left untreated and served as a control.
REMOVAL OF TEST SUBSTANCE
The eyes of 3 animals were rinsed 1 minute after application with physiologic saline.
TOOL USED TO ASSESS SCORE: hand-slit lamp.
SCORING SYSTEM
The reactions were appraised after 1 and 6 hours; 1, 2, 3, 6 and 8 days on the basis of "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the AFDO.
CORNEA
A Opacity and degree of density (most dense area scored) .
No opacity: 0
Scattered or diffuse area, details of iris clearly visible: 1
Easily discernible translucent areas, details of iris slightly obscured: 2
Opalescent areas, no details of iris visible, size of pupil barely discernible: 3
Opaque, iris invisible: 4
B Area of cornea involved
One quarter (or less) but not zero: 1
Greater than one quarter, but less than half: 2
Greater than half, but less than three quarters: 3
Greater than three quarters, up to whole area: 4
A x B x 5; Maximum possible score = 80
IRITIS
A Values
Normal: 0
Folds above normal, congestion, swelling, circumcornea injection (any or all of these or combination of any thereof) iris still reacting to light (sluggish reaction is positive: 1
No reaction to light, haemorrhage, gross destruction (any or all of these): 2
A x 5; Maximum possible score = 10
CONJUNCTIVAE
A Redness (refers to lids and bulbar conjunctivae excluding cornea and iris)
Vessels normal: 0
Vessels definitely injected above normal: 1
More diffuse, deeper crimson red, individual vessels not easily discernible: 2
Diffuse beefy red: 3
B Chemosis
No swelling: 0
Any swelling above normal (includes nictitating membrane): 1
Obvious swelling with partial eversion of lids: 2
Swelling with lids about half closed: 3
Swelling with lids about half closed to completely closed: 4
C Discharge
No discharge: 0
Any amount different from normal (does not include small amounts observed in inner cantus of normal animals): 1
Discharge with moistening of the lids and hairs just adjacent to lids: 2
Discharge with moistening of the lids and hairs, and considerable area around the eye: 3
(A + B + C) x 2; Maximum possible score = 20
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 3/3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: rinsed eye
- Irritation parameter:
- iris score
- Basis:
- animal: 3/3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: rinsed eye
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 3/3
- Time point:
- other: 24, 48, 72 hours
- Score:
- > 2
- Reversibility:
- not fully reversible within: 8 days in 2 animals
- Remarks on result:
- other: rinsed eye
- Irritation parameter:
- chemosis score
- Basis:
- animal: 3/3
- Time point:
- other: 24, 48, 72 hours
- Score:
- < 2
- Reversibility:
- not fully reversible within: 8 days in two animals
- Remarks on result:
- other: rinsed eye
- Irritant / corrosive response data:
- Test item was found to cause moderate irritation: mean reaction score after 48 hours in unrinsed eyes: 43.7 and in rinsed eyes: 38.3.
The irritation consisted of conjunctival reaction, of reflective hyperemia of the iris and of corneal reaction.
There was a tendency to regress. Rinsing the eyes led to practically the same results.
Any other information on results incl. tables
Mean values from gradings at 24, 48 and 72 hours
Reaction | Animal N. | Eye | After | Mean | ||
24 hrs | 48 hrs | 72 hrs | ||||
Cornea | 154 | not rinsed | 1 | 1 | 1 | 1.00 |
117 | not rinsed | 1 | 1 | 1 | 1.00 | |
25 | not rinsed | 1 | 2 | 2 | 1.67 | |
104 | rinsed | 1 | 1 | 1 | 1.00 | |
102 | rinsed | 1 | 1 | 1 | 1.00 | |
133 | rinsed | 1 | 1 | 1 | 1.00 | |
Iris | 154 | not rinsed | 1 | 1 | 1 | 1.00 |
117 | not rinsed | 1 | 1 | 1 | 1.00 | |
25 | not rinsed | 1 | 1 | 1 | 1.00 | |
104 | rinsed | 1 | 1 | 1 | 1.00 | |
102 | rinsed | 1 | 1 | 1 | 1.00 | |
133 | rinsed | 1 | 1 | 1 | 1.00 | |
Conjunctival redness | 154 | not rinsed | 3 | 3 | 3 | 3.00 |
117 | not rinsed | 3 | 3 | 3 | 3.00 | |
25 | not rinsed | 3 | 3 | 3 | 3.00 | |
104 | rinsed | 3 | 3 | 3 | 3.00 | |
102 | rinsed | 2 | 3 | 2 | 2.33 |
|
133 |
rinsed |
3 |
3 |
1 |
2.33 |
|
Conjunctival chemosis |
154 |
not rinsed |
2 |
1 |
1 |
1.33 |
117 |
not rinsed |
2 |
1 |
1 |
1.33 |
|
25 |
not rinsed |
2 |
1 |
1 |
1.33 |
|
104 |
rinsed |
2 |
2 |
1 |
1.67 |
|
102 |
rinsed |
2 |
1 |
1 |
1.33 |
|
133 |
rinsed |
2 |
1 |
1 |
1.33 |
Rabbit eye irritation scores-feference procedure
1 hrs |
6 hrs |
1 days |
2 days |
||||||||||||||||||||||||
Rabbit No. |
154 |
117 |
25 |
140 |
102 |
133 |
154 |
117 |
25 |
140 |
102 |
133 |
154 |
117 |
25 |
140 |
102 |
133 |
154 |
117 |
25 |
140 |
102 |
133 |
|||
Eye, left/right |
n |
n |
n |
r |
r |
r |
n |
n |
n |
r |
r |
r |
n |
n |
n |
r |
r |
r |
n |
n |
n |
r |
r |
r |
|||
I . Cornea |
|||||||||||||||||||||||||||
A Opacity |
0 |
0 |
0 |
0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
2 |
1 |
1 |
1 |
|||
B Area involved |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
|||
a = AxBx5 (Max. 80) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
20 |
20 |
20 |
20 |
20 |
20 |
20 |
20 |
20 |
20 |
20 |
20 |
|||
II . Iritis |
1 |
0 |
1 |
0 |
0 |
0 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|||
b = Score x 5 (Max. 10) |
5 |
0 |
5 |
0 |
0 |
0 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|||
III . Conjunctivae |
|||||||||||||||||||||||||||
A Redness |
2 |
3 |
3 |
2 |
1 |
2 |
3 |
3 |
3 |
2 |
1 |
2 |
3 |
3 |
3 |
3 |
2 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
|||
B Chemosis |
2 |
3 |
2 |
2 |
1 |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
1 |
1 |
1 |
2 |
1 |
1 |
|||
C Discharge |
2 |
3 |
3 |
2 |
1 |
2 |
3 |
2 |
2 |
3 |
3 |
3 |
3p |
2 |
2p |
3p |
2p |
2 |
2 |
2 |
2p |
3 |
3 |
1 |
|||
c = (A+B+C)x2 (Max. 20) |
12 |
18 |
16 |
12 |
6 |
12 |
16 |
14 |
14 |
14 |
12 |
14 |
16 |
14 |
14 |
16 |
12 |
14 |
12 |
12 |
12 |
16 |
14 |
10 |
|||
Total = a+b+c (Max. 110) |
17 |
18 | 21 | 12 | 6 | 12 | 21 | 19 | 19 | 19 | 17 | 19 | 41 | 39 | 39 | 41 | 37 | 39 | 37 | 37 | 57 | 41 | 39 | 35 | |||
Group mean |
18.7 |
10.0 |
19.7 |
18.3 |
39.7 |
39.0 |
43.7 |
39.3 |
3 days | 4 days | 8 days | ||||||||||||||||||
Rabbit No. | 154 | 117 | 25 | 140 | 102 | 133 | 154 |
117 |
25 |
140 |
102 |
133 |
154 |
117 |
25 |
140 |
102 |
133 |
||
Eye, left/right |
n |
n |
n |
r |
r |
r |
n |
n |
n |
r |
r |
r |
n |
n |
n |
r |
r |
r |
||
I . Cornea |
||||||||||||||||||||
A Opacity |
1 |
1 |
2 |
1 |
1 |
1 |
1 |
1 |
2 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
||
B Area involved |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
||
a = AxBx5 (Max. 80) |
20 |
20 |
40 |
20 |
20 |
20 |
20 |
20 |
40 |
20 |
20 |
20 |
20 |
20 |
20 |
20 |
20 |
20 |
||
II . Iritis |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
||
b = Score x 5 (Max. 10) |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
||
III . Conjuctivae |
||||||||||||||||||||
A Redness |
3 |
3 |
3 |
3 |
2 |
1 |
1 |
2 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
||
B Chemosis |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
1 |
1 |
1 |
1 |
1 |
0 |
||
C Discharge |
1 |
1 |
1p |
1p |
1 |
1 |
1 |
1 |
1 |
0 |
1 |
1 |
1 |
1 |
1 |
0 |
1 |
1 |
||
c = (A+B+C)x2 (Max. 20) |
10 |
10 |
10 |
10 |
8 |
6 |
6 |
8 |
6 |
4 |
4 |
4 |
6 |
6 |
6 |
4 |
6 |
2 |
||
Total = a+b+c (Max. 110) |
35 |
35 |
55 |
35 |
33 |
31 |
35 |
33 |
51 |
29 |
29 |
29 |
31 |
31 |
31 |
29 |
31 |
27 |
||
Group mean |
41.7 |
33.0 |
39.3 |
29.0 |
31.0 |
29.0 |
n = not rinsed
r = rinsed after 1 minute
p = purulent
Applicant's summary and conclusion
- Interpretation of results:
- other: classified in cat. 2 according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- Moderately irritating.
- Executive summary:
Method
The substance was tested for eye irritation according to the method inserted into the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO). Under the conditions of this experiment 6 rabbits were tested with 0.1 g of test item inserted into the conjunctival sac of the left eye and the lids were held open for a few seconds. The right eye was not treated and served as a control. In 3 of the 6 rabbits approximately 1 minute after treatment both eyes were rinsed with physiologic saline. The reactions were appraised with a slit lamp after 1 and 6 hours; 1, 2, 3, 6 and 8 days.
Results
Under the conditions of this experiment preparation the test item was found to cause moderate irritation when applied to the rabbit eye mucosa.
Rinsing the eyes led to practically the same results. There was a tendency to regress.
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