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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Qualifier:
according to guideline
Guideline:
other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147, November 2000, including the most recent partial revisions.
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
452-830-1
EC Name:
-
Molecular formula:
C27 H44 N2 Na2 O6 S3
IUPAC Name:
Equimolecular mixture of - Disodium 2-Hexadecylsulfanyl-1-(4-sulfo-butyl)-1H- benzoimidazole-5-sulfonate - Disodium 2-Hexadecylsulfanyl-3-(4-sulfo-butyl)-1H- benzoimidazole-5-sulfonate

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Strain: Albino Rabbit, New Zealand White (SPF-quality)

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
38.4 (37.4 - 39.4) mg
Duration of treatment / exposure:
1 second after instillation
Observation period (in vivo):
24h
Number of animals or in vitro replicates:
3 males
Details on study design:
No control animals were required because only one of the eyes was treated and the other eye remaining untreated, served as the reference control.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(mean score)
Time point:
24/48/72 h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 72hours
Remarks on result:
other: Max. score above is for opacity. Max. score for epithelial damage is 1 (maximum 25% of the corneal area).
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7days
Remarks on result:
other: Max. score above is for opacity. Max. score for epithelial damage is 2 (maximum 50% of the corneal area).
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 21days
Remarks on result:
other: Max. score above is for opacity. Max. score for epithelial damage is 3 (maximum 75% of the corneal area).
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48hours
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48hours
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48hours
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
24/48/72 h
Score:
2.7
Max. score:
3
Reversibility:
fully reversible within: 7days
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 14days
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
24/48/72 h
Score:
2.7
Max. score:
3
Reversibility:
fully reversible within: 21days
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
24/48/72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 7days
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7days
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
24/48/72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 7days
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 21 days
Other effects:
1. irritation:
The corneal injury consisted of opacity (maximum grade 1) and epithelial damage (maximum 75, 50 or 25% of the corneal area). As a result of the corneal injury, pannus (neovascularisation of the cornea) was apparent in one animal, 7 and 14 days after instillation.
Reduced elasticity of the eyelids was noted in one animal, 48 and 72 hours after instillation.
2. Corrosion:
There was no evidence of ocular corrosion.
3. Colouration/remnants:
No staining of (peri)ocular tissues by the test substance was observed and no test substance remnants were seen.
4. Toxicity/mortality:
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
According to GHS criteria, the substance should be classified as Category 2 (irritating to the eyes).