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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:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Ditin pyrophosphate
EC Number:
239-635-5
EC Name:
Ditin pyrophosphate
Cas Number:
15578-26-4
Molecular formula:
H4O7P2.2Sn
IUPAC Name:
ditin pyrophosphate
Test material form:
solid: particulate/powder

Test animals / tissue source

Species:
rabbit
Strain:
other: albino rabbit

Test system

Vehicle:
not specified
Amount / concentration applied:
100 mg
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
100 mg of the sample were plcaced in the conjunctival sac of one eye of each three albino rabbits. Reaction were scored periodically for 7 days.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 10 min/1h/2h/4h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
> 0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 4 d
Score:
2
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 5d /6d /7d
Score:
3
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 10 min/1h/2h/4h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
< 1
Max. score:
2
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 4d/5d/6d/7d
Score:
1
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 10 min
Score:
< 2
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1h/2h
Score:
2
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 4h
Score:
2
Max. score:
3
Remarks on result:
other: necrosis occures
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
2
Max. score:
3
Remarks on result:
other:
Remarks:
necrosis occures
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 4d/5d/6d/7d
Score:
3
Max. score:
3
Remarks on result:
other: necrosis occures
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 10 min
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1h/2h/4h
Score:
2
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
4
Remarks on result:
other:
Remarks:
necrosis occures
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 4d/5d/6d/7d
Score:
1
Max. score:
4
Remarks on result:
other: necrosis occures
Irritant / corrosive response data:
The irritant reaction involved all ocular tissues and appear to be irreversible.
Cornea: Althought unaffected initially, effects were evident within 24 hours. The tissue became moderately cloudy on the 4th day and markedly opacified on the 5th day.
Iris: Slight congestion appeared within 24 hours. Then intensified to swelling and increased folds.
Conjunctiva and chemosis: Moderate inflammation and chemosis appeared promptly. White necrosis became evident within 4 hours and persisted throughout.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Tin(II) pyrophosphate is classified for eye irritation (categori 1) according to Regulation (EC) n. 1272/2008 criteria.
Executive summary:

100 mg of the sample were plcaced in the conjunctival sac of one eye of each three albino rabbits. Reaction were scored periodically for 7 days.

The irritant reaction involved all ocular tissues and appear to be irreversible.

Cornea: The tissue became moderately cloudy on the 4th day and markedly opacified on the 5th day.

Iris: Congestion appeared within 24 hours.

Conjunctiva and chemosis: Moderate inflammation and chemosis appeared promptly. White necrosis became evident within 4 hours and persisted throughout.