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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:
1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Tripotassium/trisodium 5-(4-chloro-6-(N-(4-(4-chloro-6-(5-hydroxy-2,7-disulfonato-6-(2-sulfonatophenylazo)-4-naphthylamino)-1,3,5-triazin-2-yl-(N-methyl)amino)phenyl)amino)-1,3,5-triazin-2-ylamino)-4-hydroxy-3-(2-sulfonatophenylazo)naphthalene-2,7-disulfonate
EC Number:
402-150-6
EC Name:
Tripotassium/trisodium 5-(4-chloro-6-(N-(4-(4-chloro-6-(5-hydroxy-2,7-disulfonato-6-(2-sulfonatophenylazo)-4-naphthylamino)-1,3,5-triazin-2-yl-(N-methyl)amino)phenyl)amino)-1,3,5-triazin-2-ylamino)-4-hydroxy-3-(2-sulfonatophenylazo)naphthalene-2,7-disulfonate
Cas Number:
118578-11-3
Molecular formula:
Hill formula: C45H26Cl2K3N14Na3O20S6 C45H32Cl2N14O20S6.xK.xNa
IUPAC Name:
tripotassium trisodium 5-({4-chloro-6-[(4-{[4-chloro-6-({8-hydroxy-3,6-disulfo-7-[2-(2-sulfophenyl)diazen-1-yl]naphthalen-1-yl}amino)-1,3,5-triazin-2-yl]amino}phenyl)(methyl)amino]-1,3,5-triazin-2-yl}amino)-4-hydroxy-3-[2-(2-sulfophenyl)diazen-1-yl]naphthalene-2,7-disulfonate
Test material form:
solid: particulate/powder
Details on test material:
CI Reactive Red 231

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Mellor rabbits, Chedderton heights, Chedderton UK
- Weight at study initiation: 2000-2620 g for males and 1775-2736 g for females
- Housing: The rabbits were housed individually in satinised aluminium sheet cages (605mm width x 490mm depth x 455mm height). The floor of each cage was made of perforated aluminium sheet and the door was made of polycarbonate (MAKROLON).
- Diet (e.g. ad libitum): The animals were allowed free access to food and were given access to unlimited water via an automatic system.
- Acclimation period: 6 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16°C
- Humidity (%): 50±10%
- Air changes (per hr): 20-30
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light and 12 hours of darkness.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
24 h
Observation period (in vivo):
21 d
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): fir three animals irrigation was done for 2 min
- Time after start of exposure: 1 minute

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
80
Reversibility:
other: irreversible red colortion of cornea
Remarks on result:
probability of severe irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1-2 h
Score:
8
Max. score:
20
Reversibility:
fully reversible within: 7 d
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24 h
Score:
7.3
Max. score:
20
Reversibility:
fully reversible within: 7 d
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
48 h
Score:
3.3
Max. score:
20
Reversibility:
fully reversible within: 7 d
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
72 h
Score:
2.7
Max. score:
20
Reversibility:
fully reversible within: 7 d
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
7 d
Score:
0
Max. score:
20
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24 h
Score:
1.7
Max. score:
10
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
7 d
Score:
0
Max. score:
10
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.5
Max. score:
10
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
not measured/tested
Irritant / corrosive response data:
Initial Pain: Following application of 100mg of the test sample into the rabbit eye practically no initial pain reaction was seen in one animal and slight initial pain reactions were seen in the remaining animals (classes 1 and 2 on a 0-5 scale). One animal was holding its eye closed, as if in pain, 1-2 hours after application.

Irrigated Eyes: Approximately half the test sample was displaced from the conjunctival sac of one animal shortly after application.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Under the study conditions, the substance was severe irritating to rabbit eye.
Executive summary:

A study was conducted to determine the eye irritation potential of the test substance according to a method similar to OECD Guideline 405, in compliance with GLP. Six female rabbits were used for the study. 100 mg of test substance were loaded into the conjunctival sac of the left eye of the animals. Three animals were washed out with warm water after 1 minute of exposure to the test substance. One animal among the three of the washout group died after 24 h, however it was concluded that the death was not due to the test substance. In non-washout animals, up to at least 3 d after application, corneal opacity could not be assessed due to staining. In the two animals in which it was subsequently possible to assess, no signs of corneal opacity were seen. Iritis could not be assessed for up to 1 d after application in two of the animals. After this period, slight iritis was seen on Day 1 in one animal only. No iritis was seen in either of the other animals during the study. Due to staining, however, iritis could not be assessed in one of the animals until the third reading. Additional observations included corneal, iridial and conjunctival staining by the test sample, which persisted to the end of the study (21 days after application), dried secretion on the periorbital skin and three animals holding their eye closed 1-2 h after application. Due to the irreversible coloration of cornea, the test substance was considered to be a severe irritant (Pemberton, 1987).