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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
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:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
To one male and two female rabbits about 0.1 ml of undiluted Luprintan TX 4493 (= Anthraquinone-2-sulfonic acid sodium salt) was applied to the conjunctival sac of the right eyelid. The substance was not washed out. Readings according to Draize were done after 1, 24, 48 and 72 hours after the application.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
Animals species: Rabbit / White Vienna
Animal breeder: Gaukler, D-6050 Offenbach, FRG
Acclimatisation: At least 8 days before the beginning of the study
Type of cage: Stainless steel wire mesh walk floors (40 cm x 51 cm)
No. animals per cage: 1
Room temperature/ The animals were housed in fully air-conditioned rooms (20 - 24°C; relative humidity 30 - 70°C).
relative humidity
Day/night rhythm: 12 hours / 12 hours
Drinking water: About 250 ml tap water per animal per day
Diet: Kliba 341
Clipping of the fur: At least 15 hours before the beginning of the study

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 ml (unchanged)
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
72 hours
Duration of post- treatment incubation (in vitro):
None
Number of animals or in vitro replicates:
1 male and 2 female rabbits
Details on study design:
Number of animals: 1 male and 2 female rabbits
Mean weight: male: 2.79 kg; female: 3.12 kg
Application volume: 0.1 ml (unchanged)
Application site: single application to the conjunctival sac of the right eyelid; the substance was not washed out
Observation period: 72 hours
Readings: 1, 24, 48 and 72 hours after the application
Negative control: untreated eye

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
Reversibility:
other: score = 0 at any time point
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: score = 0 at any time point
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: score = 0 at any time point
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Irritant / corrosive response data:
The cornea, iris, conjunctivae and chemosis score was 0 at 24, 48 and 72 hours.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The cornea, iris, conjunctivae and chemosis score was 0 at 24, 48 and 72 hours.
Executive summary:

To one male and two female rabbits about 0.1 ml of undiluted Luprintan TX 4493 (= Anthraquinone-2-sulfonic acid sodium salt) was applied to the conjunctival sac of the right eyelid. the substance was not washed out. Readings according to Draize were done after 1, 24, 48 and 72 hours after the application. The cornea, iris, conjunctivae and chemosis score was 0 at 24, 48 and 72 hours. Therefore Luprintan TX 4493 (= Anthraquinone-2-sulfonic acid sodium salt) is not irritating to the eyes.