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Diss Factsheets

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:
June 1 to 4, 1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 3,3'-(9,10-dioxoanthracene-1,4-diyldiimino)bis(2,4,6-trimethylbenzenesulphonate)
EC Number:
224-748-4
EC Name:
Sodium 3,3'-(9,10-dioxoanthracene-1,4-diyldiimino)bis(2,4,6-trimethylbenzenesulphonate)
Cas Number:
4474-24-2
Molecular formula:
C32H30N2O8S2.2Na
IUPAC Name:
disodium 3,3'-[(9,10-dioxo-9,10-dihydroanthracene-1,4-diyl)diimino]bis(2,4,6-trimethylbenzenesulfonate)
Test material form:
other: solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kleintier farm Madoerin AG EH 4414 Fuellinsdorf/Switzerland
- Age at study initiation: 14 - 15 weeks
- Weight at study initiation: 2.8 kg
- Housing: Indlvidually in stainless steel cages equipped with an automatic cleaning and drinking system.
- Diet: PeIIeted standand KIiba 34L, Batch 25/87 and 26/87 rabbit maintenance diet ("KIiba", Klingentalmuehle AG, 4303 Kaiseraugst, Switzerland) ad libitum
- Water: ad libitum
- Acclimation period: Five days under laboratory conditions aften veterinary examination.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 40-70 %
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light/12 hours dark.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.1 g
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
Opacity
Basis:
animal: 457
Time point:
other: mean score following grading at 24, 48, 72 h
Score:
ca. 0
Max. score:
0
Reversibility:
other: no symptoms
Remarks on result:
other: not washed eye
Irritation parameter:
cornea opacity score
Remarks:
Opacity
Basis:
animal: 458
Time point:
other: mean score following grading at 24, 48, 72 h
Score:
0.66
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: not washed eye
Irritation parameter:
cornea opacity score
Remarks:
Opacity
Basis:
animal: 459
Time point:
other: mean score following grading at 24, 48, 72 h
Score:
ca. 0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: not washed eye
Irritation parameter:
iris score
Basis:
animal: 457, 458, 459
Time point:
other: mean score following grading at 24, 48, 72 h
Score:
ca. 0
Max. score:
0
Reversibility:
other: no symptoms
Remarks on result:
other: not washed eye
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal: 457, 458, 459
Time point:
other: mean score following grading at 24, 48, 72 h
Score:
ca. 0.66
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: not washed eye
Irritation parameter:
chemosis score
Basis:
animal: 457
Time point:
other: mean score following grading at 24, 48, 72 h
Score:
ca. 0
Max. score:
0
Reversibility:
other: no symptoms
Remarks on result:
other: not washed eye
Irritation parameter:
chemosis score
Basis:
animal: 458
Time point:
other: mean score following grading at 24, 48, 72 h
Score:
ca. 1
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: not washed eye
Irritation parameter:
chemosis score
Basis:
animal: 459
Time point:
other: mean score following grading at 24, 48, 72 h
Score:
ca. 0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: not washed eye

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
Not irritating
Executive summary:

Method:

The eye irritation was determined in an irritation test on rabbits according to OECD Guideline 405 and EU Method B.5.

 

Observation:

The mortality was evaluated daily while the body weights was assessed at day 1 and at termination of the test on a Mettler PK 16 balance. The eyes of each animal were examined 1, 24, 48 and 72 hours after administration. The corrosive properties of the test article and the colour of the treated eye were described and recorded. 

Result:

Corrosive