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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was not conducted according to guideline/s and GLP but the report contains sufficient data for interpretation of study results.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The eye irritation test included instillation of an aliquot of 0.1 g of the test material into each conjunctival sac of a male New.Zealand White rabbit. The right eye was washed for two minutes with tap water after a 30-second exposure. The left eye was not washed immediately after exposure. At various time intervals both eyes were examined for conjunctival irritation, corneal injury and irritation of the iris.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of Disodium decyl(sulphonatophenoxy)benzenesulphonate and Disodium oxybis[decylbenzenesulphonate]
EC Number:
915-640-4
Molecular formula:
C22 H30 O7 S2 . 2 Na
IUPAC Name:
Reaction mass of Disodium decyl(sulphonatophenoxy)benzenesulphonate and Disodium oxybis[decylbenzenesulphonate]
Details on test material:
Chemical Name : XU-40340.00. DOWFAX 3B2, Powder Form
Appearance: tan solid
Source: Specialty Chemicals Technical Services & Development Department, The Dow Chemical Company

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Male New Zealand White rabbit

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5g
Duration of treatment / exposure:
Washed eye- 30 second exposure
Unwashed eye
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
1
Details on study design:
The eyes of the rabbit were established as being without defects or irritation 24 hours prior to study initiation. The eye irritation test included instillation of an aliquot of 0.1 g of the test material into each conjunctival sac of a male New Zealand White rabbit. The right eye was washed for two minutes with tap water after a 30-second exposure. The left eye was not washed immediately after exposure. At various time intervals both eyes were examined for conjunctival irritation, corneal injury and irritation of the iris. The eyes were anesthetized if moderate pain eas observed or anticipated. A drop of 5% aqueous fluorescein stain was used to aid in assessing corneal injury.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1, 24, 48, and 72 h and 7, 14 and 21 days
Score:
4
Max. score:
6
Reversibility:
not reversible
Remarks on result:
other: eye- not washed
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 1, 24, 48 and 72 h and 7 days
Score:
4
Max. score:
6
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: eye- not washed and after stain
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 14 and 21 days
Score:
3
Max. score:
6
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: eye- not washed and after stain
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 1 h
Score:
3
Max. score:
6
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: eye- not washed
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24 and 48 h
Score:
4
Max. score:
6
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: eye- not washed
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 72 h, 7, 14 and 21 days
Score:
3
Max. score:
6
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: eye- not washed
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1 h
Score:
3
Max. score:
6
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: eye- washed
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48, and 72 h and 7 and 14 days
Score:
4
Max. score:
6
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: eye- washed
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 21 days
Score:
3
Max. score:
6
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: eye- washed
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 1, 24, 48, and 72 h and 7 days
Score:
4
Max. score:
6
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: eye- washed and after stain
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 14 days
Score:
3
Max. score:
6
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: eye- washed and after stain
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 21 days
Score:
2
Max. score:
6
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: eye- washed and after stain
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 1 h
Score:
2
Max. score:
6
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: eye- washed
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48 and 72 h and 7 days
Score:
3
Max. score:
6
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: eye- washed
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 14 and 21 days
Score:
2
Max. score:
6
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: eye- washed
Irritant / corrosive response data:
The eye irritation test included instillation of an aliquot of 0.1 g of the test material into each conjunctival sac of a male New.Zealand White rabbit. The single exposure resulted in moderate discomfort, moderate conjunctival redness and swelling, moderate reddening of the iris, and moderate corneal injury. Ocular effects were still present in both eyes at day 21 of the test and included slight to moderate conjunctival irritation, slight corneal injury, and slight reddening of the iris. Ophthalmic anesthetic was administered to alleviate discomfort experienced by the rabbit.
Other effects:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Remarks:
Not reversible
Conclusions:
A single exposure of New Zealand White rabbit eyes to the test material resulted in moderate discomfort, moderate conjunctival redness and swelling , moderate reddening of the iris, and moderate corneal injury. Ocular effects were still present in both eyes at day 21 of the test and included slight to moderate conjunctival irritation, slight corneal injury, and slight reddening of the iris. Ophthalmic anesthetic was administered to alleviate discomfort experienced by the rabbit.
Executive summary:

The test material, XU-40340.00 DOWFAX 3B2 powder form, was submitted by the Specialty Chemicals Technical Services & Development Department, The Dow Chemical Company, Midland, MI. The material is of interest for use in the agriculture, cleaning, and textile industries. Standard acute toxicologic tests were conducted and included the acute oral toxicity, skin irritation, and eye irritation studies.

A single exposure of New Zealand White rabbit eyes to the test material resulted in moderate discomfort, moderate conjunctival redness and swelling , moderate reddening of the iris, and moderate corneal injury. Ocular effects were still present in both eyes at day 21 of the test and included slight to moderate conjunctival irritation, slight corneal injury, and slight reddening of the iris. Ophthalmic anesthetic was administered to alleviate discomfort experienced by the rabbit.