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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: Study follows acceptable practices. Conducted prior to GLP regulations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: US FHSLA, CFR, Title 21, para. 191.12
Deviations:
not specified
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: viscous as 50% solution in light paraffinic petroleum oil as placed on the market
Details on test material:
A brown-black viscous liquid:
50% DNNSA (DI C8-C10, BRANCHED, C9 RICH, ALKYLNAPHTHALENE SULFONIC ACID)
50% light paraffinic petroleum oil

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
One tenth of a milliliter of test material was instilled in one eye of each rabbit. The other eye of each rabbit remained untreated and served
as a control. The treated eyes were not washed. The rabbits were immobil ized in head stocks for 24 hours and then returned to their cages.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 ml 50% solution in light paraffinic petroleum oil as placed on the market
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
Ocular lesions were evaluated at 24, 48 and 72 hours and at 4, 7 and 14 days after treatment.
Number of animals or in vitro replicates:
6
Details on study design:
Methods of dosing are similar to Daize procedure except untreated eye used as a control.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 6 rabbits
Time point:
other: 24 h
Score:
2.33
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 6 rabbits
Time point:
other: 48 h
Score:
2.67
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 6 rabbits
Time point:
other: 72 h
Score:
2.67
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 6 rabbits
Time point:
other: 24 h
Score:
1.33
Max. score:
2
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 6 rabbits
Time point:
other: 48 h
Score:
1.67
Max. score:
2
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 6 rabbits
Time point:
other: 72 h
Score:
1.83
Max. score:
2
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 6 rabbits
Time point:
other: 24 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 6 rabbits
Time point:
other: 48 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 6 rabbits
Time point:
other: 72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 6 rabbits
Time point:
other: 24 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 6 rabbits
Time point:
other: 48 h
Score:
3.83
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 6 rabbits
Time point:
other: 72 h
Score:
3.67
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritant / corrosive response data:

The test material is a severe primary eye irritant.
Other effects:
No clinical signs of adverse effects were observed.

Any other information on results incl. tables

See detailed results and scoring procedure in attached document (next section).

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
DNNSA as a 50% formulation in light petroleum oil is a severe primary eye irritant in rabbits.
Executive summary:

Synex 1052, a 50% DNNSA formulation in light petroleum oil was tested for primary eye irritation in New Zealand White rabbits.

One tenth of a milliliter of test material was instilled in one eye of each rabbit. Six rabbits were treated. The other eye of each rabbit remained untreated and served as a control. The treated eyes were not washed. The rabbits were immobilized in head stocks for 24 hours and then returned to their cages. Ocular lesions were evaluated at 24, 48 and 72 hours and at 4, 7 and 14 days after treatment.

No clinical signs of adverse systemic effects were observed. The test material is a severe primary eye irritant.