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Diss Factsheets

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:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
no GLP study, no information about cornea and iris scores.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
no information about cornea and iris scores.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Manganese, 3-hydroxy-4-[(1-sulfo-2-naphthalenyl)azo]-2-naphthalenecarboxylic acid complex
EC Number:
252-525-1
EC Name:
Manganese, 3-hydroxy-4-[(1-sulfo-2-naphthalenyl)azo]-2-naphthalenecarboxylic acid complex
Cas Number:
35355-77-2
Molecular formula:
C21H12MnN2O6S
IUPAC Name:
manganese(2+) hydrogen 3-oxido-4-[(E)-(1-sulfonatonaphthalen-2-yl)diazenyl]naphthalene-2-carboxylate
Test material form:
solid: particulate/powder
Details on test material:
- Physical state: purple powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: 11-16 weeks
- Mean body weight at study initiation: males 2.57 and females 2.60 kg
- Housing: the rabbits were caged singly in an experimental room
- Diet: A commercial diet (Styles-Oxid) was fed ad lib.
- Water: sterile filtered water was available at all times
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 50-70
- Photoperiod: Animals were exposed to artificial light for 10 hours daily from 08.00 - 18.00 hours

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 100 mg
Duration of treatment / exposure:
single treatment
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6
Details on study design:
- the test substance was instilled into the conjunctival sac of the left eye. The eyelids were then closed for one second.
- the non-treated left eye served as control

REMOVAL OF TEST SUBSTANCE
- Washing: after 30 seconds the compounds was, as far as possible, flushed out of the eyes of three of the six rabbits with warm water for 1 minute

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.11
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: washed eyes
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: washed eyes
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.55
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: not washed eyes
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: not washed eyes
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: washed eyes
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
other: washed eyes
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
other: washed eyes
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: washed eyes
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: washed eyes
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: washed eyes
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: not washed eyes
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 28 hours
Remarks on result:
other: not washed eyes
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
other: not washed eyes
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: not washed eyes
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: not washed eyes
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: not washed eyes

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Only based on the given results for the conjunctiva, the test compound is not considered irritating to the eye.
Executive summary:

In an acute eye irritation/corrosion study with New Zealand White rabbits, 100 mg of the test compound were instilled into the conjunctival sac of the left eye of six rabbits (3/sex). The eyelids were then closed for one second. After 30 seconds the test item was washed out of the eyes of three of the rabbits. The eyes of the remaining three animals were not washed out. The rabbits were examined 1, 24, 48 and 72 hours after application of the test compound. A very slight to mild conjuctival reaction was seen in 3/3 unwashed and 2/3 washed eyes one hour after application of the compound. By 24 hours 3/3 unwashed and 1/3 washed eyes were showing a very slight reaction. These rapidly returned to normal by 48 hours (2/3 unwashed, 1/3 washed eyes) and 72 hours (1/2 in washed eyes). The observed mean conjunctivae scores for the washed and unwashed eyes were 0.11 and 0.55, respectively. After 1 hour of application 2/3 washed and unwashed eyes showed slight chemosis. This effects were fully reversible within 48 hours and a mean chemosis score (24,48,72h) of 0 was determined for both, washed and unwashed eyes.The effects of the test substance on the iris and the cornea were not investigated in this study.