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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Method not decribed in detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: FDA [Fed. Reg. 28 (119), 5582, 1963] / Draize, Kelley [Drug Cosmet. Industr. 71 (1952) 36]
Principles of method if other than guideline:
Formamidine sulfinic acid was tested for eye irritation according to procedures published by the FDA (1963) and Draize and Kelley (1952).
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other:
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
Duration of treatment / exposure:
24 h
Observation period (in vivo):
7 days
Reading time points: 24, 48 and 72 h and 7 days
Number of animals or in vitro replicates:
6
Details on study design:
SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
other: mean out of 6 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
1.22
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
other: mean out of 6 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0.6
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
other: mean out of 6 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
other: mean out of 6 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritant / corrosive response data:
After 24h the effects on eye caused by the test material generally consisted of slight opacity of the cornea, slight iritis (3/ animals), and moderate redness and slight to severe swelling of conjuctivae. In the course of 7–day observation period some of these eye effects recovered partly or completely.
However, after 7 days slight of moderate to severe corneal opacity and vascularization on the cornea were observed in 4/6 rabbits, ulcus cornea in 2/6 animals, slight iritis in 3/6 rabbits and slight lesions of the conjuctivae in all six animals.

Any other information on results incl. tables

Table 1.Individual scores awarded tpthe ocular lesions elicited by the test item

 

 

 

Conjuctivae

Animal No.

Cornea

Iris

Redness

chemosis

after 24 hours

1

0

0

2

1

2

1

1

2

2

3

1

0

2

2

4

1

1

2

3

5

1

0

2

3

6

1

1

2

3

after 48 hours

1

1

1

2

2

2

1

1

2

2

3

1

0

2

3

4

2

1

2

3

5

2

1

2

3

6

1

0

2

2

after 72 hours

1

1-2

1

2

2

2

1

0

2

2

3

1

1

2

2

4

2

1

2

2

5

2

1

2

2

6

1

0

2

2

after 7 days

1

1

1

1

1

2

0

0

1

1

3

1

1

1

1

4

2

0

1

1

5

2-3

1

1

2

6

0

0

1

1

Mean out of 6 animals over 24, 48 and 72 h

1.22

0.6

2

2.27

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: Eye Dam 1, H318
DSD: Xi, R41
Executive summary:

It was concluded that according to the FDA standards formamidine sulfinic acid was a severe eye irritant.