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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:
1997
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
92/69/EEC
Deviations:
not specified
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
-
EC Number:
424-870-1
EC Name:
-
Cas Number:
27624-67-5
IUPAC Name:
2,4-diamino-5-[[4-(2-sulfooxyethylsulfonyl)phenyl]diazenyl]benzenesulfonic acid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
86 mg
Duration of treatment / exposure:
Not specified
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: Draize’s

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.3
Max. score:
2
Reversibility:
not specified
Remarks on result:
other: Max. duration: 72 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
2
Reversibility:
not specified
Remarks on result:
other: Max. duration: 72 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not specified
Remarks on result:
other: Max. duration: 72 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
2
Reversibility:
not specified
Remarks on result:
other: Max. duration: 24 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
not specified
Remarks on result:
other: Max. duration: 24 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
2
Reversibility:
not specified
Remarks on result:
other: Max. duration: 24 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
1
Reversibility:
not specified
Remarks on result:
other: Max. duration: 48 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
not specified
Remarks on result:
other: Max. duration: 48 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
not specified
Remarks on result:
other: Max. duration: 48 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.3
Max. score:
2
Reversibility:
not specified
Remarks on result:
other: Max. duration: 48 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
2
Reversibility:
not specified
Remarks on result:
other: Max. duration: 48 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
2
Reversibility:
not specified
Remarks on result:
other: Max. duration: 48 h; Max. value at end of observation period: 0 (related to all animals)
Irritant / corrosive response data:
Reversibility of any observed effect: changes not fully reversible within 21 days
Other effects:
Residual test material was noted around the treated eye of all animals throughout the study. Orange-colored staining was noted in all treated eyes during the study. Dulling of the normal lustre of the cornea was noted in two treated eyes one hour after treatment, in all treated eyes at the 24-hour observation and in one treated eye at the 48-hour observation. No other corneal effects were noted. Orange-colored staining prevented accurate evaluation of the iris in all treated eyes one hour after treatment, in two treated eyes at the 24-hour observation and in one treated eye at the 24-hour observation. The staining persisted in the two surviving animals up to and including the 21-day observation. Iridial inflammation was noted in one treated eye at the 24-hour observation. No other iridial effects were noted.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
The substance is classified as serious eye damage due to its persistent and severe effects on the eye.
Executive summary:

An in vivo test was conducted to assess the eye irritating effects of the test material Everzol Yellow GSP (EC 424-870-1). Three individuals of New Zealand white rabbit were tested with the selected dose of 86 mg and the effects were recorded according to the Draize’s scoring system for the first 24, 48 and 72 hours after treatment: orange-colored staining was noted in all treated eyes during the study and prevented accurate evaluation of the iris in all treated eyes one hour after treatment, in two treated eyes at the 24-hour observation and in one treated eye at the 24-hour observation while dulling of the normal lustre of the cornea was noted in two treated eyes one hour after treatment, in all treated eyes at the 24-hour observation and in one treated eye at the 48-hour observation. The staining persisted in the two surviving animals up to and including the 21-day observation (one animal was found dead Day 18; the cause of death was not determined but was considered not to be treatment related).
Therefore, due to its persistent staining effects, moderate but persistent eye lesions, eye corrosion Everzol Yellow GSP (EC 424-870-1) was considered a severe eye irritant and labelled with the EU risk phrase R41 (risk of serious damage to eyes).