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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
Study period:
From November 5, 1990 to November 12, 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
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:
yes

Test material

Constituent 1
Reference substance name:
A mixture of: trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(4-(4-nitro-2-sulfonatoanilino)phenylazo)phenolato)ferrate(1-); trisodium bis(2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)ferrate(1-); trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(4-nitro-2-sulfonatophenylazo)phenolato)ferrate(1-); trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(3-sulfonatophenylazo)phenolato)ferrate(1-); disodium 3,3'-(2,4-dihydroxy-1,3(or 1,5 or 3,5)-phenylenediazo)dibenzenesulfonate
EC Number:
406-870-1
EC Name:
A mixture of: trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(4-(4-nitro-2-sulfonatoanilino)phenylazo)phenolato)ferrate(1-); trisodium bis(2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)ferrate(1-); trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(4-nitro-2-sulfonatophenylazo)phenolato)ferrate(1-); trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(3-sulfonatophenylazo)phenolato)ferrate(1-); disodium 3,3'-(2,4-dihydroxy-1,3(or 1,5 or 3,5)-phenylenediazo)dibenzenesulfonate
Cas Number:
115100-55-5
Molecular formula:
not applicable
IUPAC Name:
triiron(3+) nonasodium 2-(2-{4-hydroxy-2-oxido-5-[2-(3-sulfophenyl)diazen-1-yl]phenyl}diazen-1-yl)-4,6-dinitrobenzen-1-olate 2-(2-{5-[2-(3,5-dinitro-2-oxidophenyl)diazen-1-yl]-2-hydroxy-4-oxidophenyl}diazen-1-yl)-4,6-dinitrobenzen-1-olate tris(2-(2-{5-[2-(3,5-dinitro-2-oxidophenyl)diazen-1-yl]-4-hydroxy-2-oxidophenyl}diazen-1-yl)-4,6-dinitrobenzen-1-olate) 2-{2-[4-hydroxy-5-(2-{4-[(4-nitro-2-sulfophenyl)amino]phenyl}diazen-1-yl)-2-oxidophenyl]diazen-1-yl}-4,6-dinitrobenzen-1-olate
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:
TEST ANIMALS
- Source: Broekman Instltute, Someren, The Netherlands.
- Age at study initiation: ~ 14 weeks
- Weight at study initiation: 2144 - 2766 grams
- Housing: Individually in cages with perforated floors and equipped with an automatic drinking system (ITL, Bergen, The Netherlands).
- Diet (e.g. ad libitum): Standard laboratory rabbit diet (LKK-20, pellet diameter 4 mm, Hope Farms, Woerden, The Netherlands) approx. 100 g per day.
- Water (e.g. ad libitum): Free access to tap-water diluted with decalcified water.
- Acclimation period: five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 °C
- Humidity (%): 55 %
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): Lighting was 12 hours artificial f!uorescent light and 12 hours dark per day.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 72 mg
Duration of treatment / exposure:
single injection into the conjunctival sac
Observation period (in vivo):
72 hours of observation period
Number of animals or in vitro replicates:
3 female rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes.
Immediately after fluorescein examination on day 2, both eyes of all three animals were rinsed with approx 50 ml tepid tap-water, using a velocity of flow which did not affect the eyes, to try to remove residual test substance.

SCORING SYSTEM:
CORNEA
-Opacity: degree of density (area most dense taken for reading)
No ulceration or opacity: 0
Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly
visible: 1
Easily discernible translucent area, details of iris slightly obscured: 2
Nacreous areas, no details of iris visible, size of pupil barely discernible: 3
Opaque cornea, iris not discernible through the opacity: 4
-Area of cornea affected
No ulceration or opacity: 0
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
IRIS
Normal: 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia, or injection,
any of these or any combination thereof, iris still reacting to light (sluggish reaction is positive): 1
No reaction to light, haemorrhage, gross destruction (any or all of these): 2
CONJUNCTIVAE
-Redness: (refers to palpebral and bulbar conjunctivae, excluding cornea and iris).
Blood vessels normal
Some blood vessels definitely hyperaemic (injected): 1
Diffuse, crimson colour, individual vessels not easily discernible: 2
Diffuse beefy red: 3
-Chemosis: lids and/or nictating membrane
No swelling: 0
Any swelling above normal (includes nictating membrana): 1
Obvious swelling with partial eversion of lids: 2
Swelling with lids about half closed: 3
Swelling with lids more than half closed: 4
-Discharge:
No discharge: 0
Any amount different from normal (does not include small amounts observed in inner canthus 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, in a considerable area around the eye: 3.

TOOL USED TO ASSESS SCORE: 2% fluorescein in water (adjusted to pH 7.0)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: rinsed eye
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: rinsed eye
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: rinsed eye
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: rinsed eye
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.33
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: rinsed eye
Irritation parameter:
chemosis score
Basis:
animal: #1 and #3
Time point:
24/48/72 h
Score:
0.33
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: rinsed eye
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: rinsed eye
Irritant / corrosive response data:
Instillation of substance into one of the eyes of each of three albino rabbits affected the conjunctivae in all animals.
The irritation of the conjunctivae was reversible within 72 hours in animal #3 and within 7 days in animals #1 and #2.
Treatment of the eyes with 2% fluorescein, 24 hours after test substance instillation revealed no corneal epithelial damage in any of the animals.
Other effects:
Brown staining of the treated eye, head and paws by the test substance was observed.
No toxic symptoms were observed in the animals during the test period and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:
other: not classified according to the CLP regulation (EC) no. 1272/2008
Conclusions:
The test substance was not irritatibng for rabbit eye.
Executive summary:

The purpose of this study was to assess the possible irritation or corrosion potential when a single dose of was placed in the conjunctival sac of a rabbit eye.

This study was carried out in accordance with OECO Guideline No. 405, "Acute Eye Irritation / Corrosion" and EEC Directive 84/449/EEC, Part B.5, "Acute Toxicity - Eye Irritation".

The substance was instilled In one of the eyes of each of the three animals, followed by five observations at approximately 1, 24, 48 and 72 hours and 7 days after test article administration. Under the conditions of this study, the substance resulted in adverse effects of the conjunctivae. The irritation of the conjunctivae was reversible within 72 hours in one animal and within 7 days 1n the other two animals. No ocular corrosion was observed In any of the animals. No signs of systemic intoxication were observed during the study period. The mean eye irritation scores (24, 48, 72 h) for corneal opacity and iritis were 0 in all treted animals; conjunctival redness scores were 1, 2 and 1.33 in animals #1, #2 and #3 and chemosis scores were 0.33 in animals #1 and #3 and 1 in animal #2. Al the effects observed were reversible within 7 -day study period.