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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:
24.08.1982 to 27.08.1982
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
[[(phosphonomethyl)imino]bis[(ethylenenitrilo)bis(methylene)]]tetrakisphosphonic acid, sodium salt
EC Number:
244-751-4
EC Name:
[[(phosphonomethyl)imino]bis[(ethylenenitrilo)bis(methylene)]]tetrakisphosphonic acid, sodium salt
Cas Number:
22042-96-2
Molecular formula:
C9H28N3O15P5.xNa
IUPAC Name:
sodium hydrogen [10,10-dihydroxy-10-oxido-2,5,8-tris(phosphonomethyl)-2,5,8-triaza-10-phosphadec-1-yl]phosphonate
Constituent 2
Reference substance name:
[[(phosphonomethyl)imino]bis[(ethylenenitrilo)bis(methylene)]]tetrakisphos phonic acid, sodium salt
IUPAC Name:
[[(phosphonomethyl)imino]bis[(ethylenenitrilo)bis(methylene)]]tetrakisphos phonic acid, sodium salt
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Albino New Zealand White rabbits were used (12-16 weeks old, body weight range 2.15-2.34 kg, supplied by Hylyne Rabbits Ltd., Marston, Northwich, Cheshire, UK). 

Test system

Vehicle:
unchanged (no vehicle)
Remarks:
aqueous solution, administered undiluted.
Controls:
not required
Amount / concentration applied:
Amount applied: 0.1 ml
Duration of treatment / exposure:
0.1 ml test substance (equivalent to 58 mg active salt) was instilled into the conjunctival sac of the right eye of each animal.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
Three
Details on study design:
Comment: other: No indication that eye was rinsed.
Responses were evaluated 1, 24, 48 and 72 hours after dosing.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48 and 72
Score:
0
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The test substance produced no evidence of an ocular irritation in any rabbit. A dulling of the normal lustre of the cornea was observed in all three rabbits at the one hour reading, accompanied in one rabbit by iritis. A diffuse crimson-red colouration of the conjunctivae accompanied by slight or distinct swelling with partial eversion of the eyelids was observed in two rabbits at this reading. Mild conjunctival inflammation and swelling was observed in the remaining animal. The reactions had reversed in all three animals by the 24 hour reading.
Other effects:
None reported.

Any other information on results incl. tables

CORNEA
No scored effects, but dulling of the cornea was observed in
all 3 animals, 1 hour after dosing.  Total score 0.

IRIS
Score 1 in 1 animal, 1 hour after dosing.  Total score 1.

CONJUCTIVAL REDNESS
Score 2 in 2 animals and score 1 in the third, 1 hour after
dosing.  Total score 5.

CONJUNCTIVAL CHEMOSIS
Score 2 in 1 animal and score 1 in 2 animals, 1 hour after
dosing.  Total score 4.  

From 24 hours after dosing, no abnormal symptoms observed
any animal.  

Group total score = 10.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In the eye irritation study with DTPMP-7Na, conducted according to OECD Test Guideline 405 and in compliance with GLP, DTPMP-7Na was concluded to be not irritating to the eyes of rabbits.