Registration Dossier

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
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
other: Information from migrated NONS file as per inquiry # [06-0000024522-76-0000], permission to refer granted by ECHA
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 84/449/EWG, B.5
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
4-[(3-hydroxypropyl)amino]-3-nitrophenol
EC Number:
406-305-9
EC Name:
4-[(3-hydroxypropyl)amino]-3-nitrophenol
Cas Number:
92952-81-3
Molecular formula:
C9H12N2O4
IUPAC Name:
4-[(3-hydroxypropyl)amino]-3-nitrophenol

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
0.1 ml
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 hr
Score:
1.7
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 hr
Score:
0.7
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 hr
Score:
1
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
other: -
Time point:
other: -
Score:
2
Max. score:
2
Remarks on result:
other: Max. duration : 72 h; Max. value at end of observation period : 1(related to all animals)
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 hr
Score:
1
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 hr
Score:
0.3
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 hr
Score:
0.7
Irritation parameter:
chemosis score
Basis:
other: -
Time point:
other: -
Score:
2
Max. score:
2
Remarks on result:
other: Max. duration : 48 hr ; Max. value at end of observation period : 0 (related to all animals)
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 hr
Score:
1
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 hr
Score:
0.7
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 hr
Score:
0.7
Irritation parameter:
cornea opacity score
Basis:
other: -
Time point:
other: -
Score:
1
Max. score:
1
Remarks on result:
other: Max. duration : 72 hr; Max. value at end of observation period: 1 (related to all animals)
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 hr
Score:
0.7
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 hr
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 hr
Score:
0.3
Irritation parameter:
iris score
Basis:
other: -
Time point:
other: -
Score:
1
Max. score:
1
Remarks on result:
other: Max. duration : 48 hr; Max. value at end of observation period : 0 (related to all animals)
Irritant / corrosive response data:
Reversibility of any observed effect : Changes fully reversible within 7 days

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The substance was not classified as a eye irritant.