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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
Study period:
01 - 04 Dec 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium 1-amino-9,10-dihydro-9,10-dioxo-4-[[4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]anthracene-2-sulphonate
EC Number:
240-267-2
EC Name:
Disodium 1-amino-9,10-dihydro-9,10-dioxo-4-[[4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]anthracene-2-sulphonate
Cas Number:
16102-99-1
Molecular formula:
C22H18N2O11S3.2Na C22H16N2Na2O11S3
IUPAC Name:
disodium 1-amino-9,10-dioxo-4-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)amino]-9,10-dihydroanthracene-2-sulfonate
Test material form:
solid: particulate/powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Albino New Zealand Rabbit
Food: Altromin 2123 rabbit
Water: deionised chlorinated water
Food and water ad libitum
Single housing
Weight: 2.4 - 2.9 kg
Age: ca. 3 - 5 months
Room temperature: 20°C
Relative air humidity: 50%

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
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):
1, 24, 48, 72 h after exposure
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): 24 h after study initiation with physiological NaCl solution

SCORING SYSTEM: according to OECD TG 405

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Swellings occured 1 h after application in 3 / 3 animals. Swelling of conjuctivae occured 24 h after application in 1 / 3 animals. All signs of irritation were fully reversible within 48 h.
Other effects:
Hyperemia of conjunctival blood vessels in 3 / 3 animals
Iris coloured blue in 3 / 3 animals

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No significant signs of irritation occured in an OECD 405 with rabbits. All symptoms were fully reversible within 48 h (conjuctivae, chemosis). The test item does not fulfill the criteria for classification according to the CLP Regulation.