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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Details on test material:
- Name of test material (as cited in study report): "WS 400304"
- Molecular formula: C7H8O3S.C5H5N
- Physical state: White solid
- Analysis: acid value 202, base value 2
- Trade name: BYK-LP K 20953
- Supplier: BYK Chemie
- Lot/batch No.: CD-05-167
- Expiration date of the lot/batch: 2008-01-01
- Stability under test conditions: Stable
- Storage condition of test material: Room temperature
- Other:
* pH=3.74 (1% solution in deionised water)
* density 1.25 g/cm3 at 60 °C
* Soluble in water

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Supplier: Charles River Deutschland GmbH, D-97633 Sulzfeld
- Number and sex: 3 males
- Bodyw eights (at the start and at the termination of the study):
Animal No. 61: 2.2 kg and 2.5 kg
Animal No. 62: 2.3 kg and 2.6 kg
Animal No. 63: 2.0 kg and 2.4 kg
- Cages: individual caging in metal wire cages, Ehret GmbH, D-79312 Emmendingen, type KK 016R, 79 cm x 59 cm bottom area, 38 cm height.
- Room temperature: 19.0 °C
- Relative humidity: 48.4 %
- Light: artificial light from 6 a.m. to 6 p.m.
- Feed: Altromin 2123 maintenance diet for rabbits, rich in crude fiber, ad libitum. Hay-briquettes (supplied by SSNOFF, D-59494 Soest) were offered additionally as a dietary supplement.
- Water: tap water from an automatic watering system, ad libitum
- Acclimatisation: 5 days (animal No. 61) and 12 days (animal No. 62 and 63)

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye served as a negative control.
Amount / concentration applied:
The test substance consisted of a crystalline and a viscous part. Before the instillation into the eyes the test substance was given into a mortar for grinding the crystals. 0.1 ml of the resulting viscous mass was administered per animal into the conjunctival sacs of the right eyes. The left eyes remained untreated and served as control.
Firstly, the test substance was given to one animal. As no evidence for a serious damage to the eye of this animal wa found during the initial 72 hours observation period, the test substance was administered to the other two animals subsequently.
Duration of treatment / exposure:
Not specified
Observation period (in vivo):
1, 24, 48 and 72 hours and 7 days after the administration of the test substance
Number of animals or in vitro replicates:
3 males
Details on study design:
Both eyes of the animals were examined 24 hours before the instillation and approximately 1, 24, 48 and 72 h p.a.
Further examination was performed in all animals 24 h after administration by instillation of a fluorescein solution (Minims Fluorescein Sodium 2%) onto the cornea. The whole eyes, especially the corneae, the irises and the conjunctivae were examined using an otoscope lamp.
Calculation of the MMAS (Modified Maximum Average Score) was performed according to the ECETOC Technical Report No.48(2), 1998 (Eye Irritation Reference Chemicals Data Bank, 2nd ed.)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48 h
Score:
1
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24 h
Score:
1
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48 h
Score:
2
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24 h
Score:
3
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
48 h
Score:
2
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24 h
Score:
2
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
48 h
Score:
1
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Other effects:
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occured.

Applicant's summary and conclusion

Interpretation of results:
other: not irritating