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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study performed according to OECD guideline 405 and in compliance to GLP.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991
Reference Type:
review article or handbook
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-(2,4-diaminophenoxy)ethanol dihydrochloride
EC Number:
266-357-1
EC Name:
2-(2,4-diaminophenoxy)ethanol dihydrochloride
Cas Number:
66422-95-5
Molecular formula:
C8H12N2O2.2ClH
IUPAC Name:
2-(2,4-diaminophenoxy)ethan-1-ol dihydrochloride
Details on test material:
Test item : Imexine OAJ
EC number : 266-357-1
Batch number : Op 118
Purity : 99.4%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
100 mg undiluted.
Duration of treatment / exposure:
On day 1, a 100mg sample of neat Imexine OAJ was instilled in the conjunctival sac of the left eye of the animals. The eyes were not rinsed following instillation of the test item. The non-treated right eye served as a control. The ocular reactions were assessed 1, 24, 48 and 72 hours after instillation, as well as on day 8 and day 15.
Observation period (in vivo):
The ocular reactions were assessed 1, 24, 48 and 72 hours after instillation, as well as on day 8 and day 15.
Number of animals or in vitro replicates:
3 females

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 hours
Score:
2
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 hours
Score:
3
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 hours
Score:
2
Irritation parameter:
chemosis score
Max. score:
3
Remarks on result:
other: Max. duration, max. value at end of observation period related to all animals
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
(cumulative)
Time point:
other: 72 hours
Score:
2.33
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 hours)
Score:
1.67
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 hours
Score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 hours
Score:
2
Irritation parameter:
conjunctivae score
Max. score:
2
Remarks on result:
other: Max. duration, max. value at end of observation period related to all animals
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
(cumulative)
Time point:
other: 72 hours
Score:
1.89
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 hours
Score:
1
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall 24, 48 and 72 hours
Score:
1
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 hours
Score:
1
Irritation parameter:
iris score
Max. score:
1
Remarks on result:
other: Max. duration, max. value at end of observation period related to all animals
Irritation parameter:
iris score
Basis:
mean
Remarks:
(cumulative)
Time point:
other: 72 hours
Score:
1
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 hours
Score:
2
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 hours
Score:
2
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 hours
Score:
1.33
Irritation parameter:
cornea opacity score
Max. score:
2
Remarks on result:
other: Max. duration, max. value at end of observation period related to all animals
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
(cumulative)
Time point:
other: 72 hours
Score:
1.78

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Imexine OAJ (2-(2,4-diaminophenoxy)ethanol dihydrochloride) was considered to be an irritant to rabbit eyes when tested undiluted. At the end of the observation period of 15 days the effects were not reversible thus justifying a category 1 classification.
Executive summary:

The eye irritation potential of the substance 2-(2,4-diaminophenoxy)ethanol dihydrochloride was assessed according to OECD guideline 405 in compliance to GLP. On day 1, a 100mg sample of neat Imexine OAJ was instilled in the conjunctival sac of the left eye of the animals. The eyes were not rinsed following instillation of the test item. The non-treated right eye served as a control. The ocular reactions were assessed 1, 24, 48 and 72 hours after instillation, as well as on day 8 and day 15. Marked ocular reactions were observed. They included moderate to marked chemosis and slight to moderate redness of conjunctivae, slight to moderate corneal opacification and slight iridal lesions. At the end of the observation period of 15 days the effects were not reversible thus justifying a category 1 classification.