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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:
from 2008-01-07 till 2008-01-12
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline-conform study under GLP without deviations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
2004/73/EG, B.5
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
483-300-8
EC Name:
-
Cas Number:
99580-93-5
Molecular formula:
Hill formula: C3H13N2O3P CAS formula: C2H8N2.CH5O3P
IUPAC Name:
1,2-Ethanediamine methylphosphonate
Details on test material:
Batch number: FEB 278-810
Nature of substance: solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
rbt, New Zealand White Hsd If:NZW (SPF)

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated contralateral eye served as control.
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
Time point:
other: overall at 24, 48 and 72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Time point:
other: 24 - 72 hours
Score:
0 - <= 0.33
Max. score:
1
Reversibility:
fully reversible
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 #1
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 - 72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 - 72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Max. duration: h; 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 2 days.

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Considering the reported data of this irritation study it can be stated that the test item produced slightly to diffuse irritating effects, which were fully reversible.
According to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 2001/59/EC) the test item does not have to be classified and has no obligatory labelling requirement for eye irritation.