Registration Dossier

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 without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 16 CFR 1500.41
GLP compliance:
no
Remarks:
Study conducted prior to implementation of GLP

Test material

Constituent 1
Chemical structure
Reference substance name:
1,4-dichloro-5,8-dihydroxyanthraquinone
EC Number:
220-599-4
EC Name:
1,4-dichloro-5,8-dihydroxyanthraquinone
Cas Number:
2832-30-6
Molecular formula:
C14H6Cl2O4
IUPAC Name:
1,4-dichloro-5,8-dihydroxy-9,10-dihydroanthracene-9,10-dione

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Lippische Versuchstierzucht / Extertal 1
- Weight at study initiation: 2.1 kg (average)
- Housing: individual cages
- Diet (e.g. ad libitum): "mümmel z" (ssniff / Soest)
- Water (e.g. ad libitum): yes
- Acclimation period: 7-14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-18
- Humidity (%): 40 r.h.
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 100 µL bulk volume/animal
Duration of treatment / exposure:
>1 sec (application in conjunctival sac of right eyelids, manually closed for 1 sec, eyes not rinsed after treatment)
Observation period (in vivo):
24, 48 and 72 h after start of application, observation control after 8 days
Number of animals or in vitro replicates:
6
Details on study design:
SCORING SYSTEM: "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics", FDA, 1959, p.51

TOOL USED TO ASSESS SCORE: fluorescein

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: 48 h
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other:
Remarks:
score = 0
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other:
Remarks:
score = 0
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other:
Remarks:
score = 0
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other:
Remarks:
score = 0
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other:
Remarks:
score = 0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other:
Remarks:
score = 0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
cornea opacity: <=25% of cornea size with opacity spots, iris clearly visible in animals #1 and #2 within 24 hours of application (fully reversible within 24 hours); all other animals showed cornea and iris score 0.
conjunctivae: discharge with wetted eyelids and hairs directly at eyelids in one animal (#6) within 24 hours of application (fully reversible within 24 hours); all other animals showed score 0 on conjunctivae

Any other information on results incl. tables

Table: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility Cornea Iris Conjunctivae Chemosis
Max. score: 4 Max. score: 2 Max. score: 3 Max. score: 4
24 h 1/1/0/0/0/0 0/0/0/0/0/0 0/0/0/0/0/2 0/0/0/0/0/0
48 h 0/0/0/0/0/0 0/0/0/0/0/0 0/0/0/0/0/0 0/0/0/0/0/0
72 h 0/0/0/0/0/0 0/0/0/0/0/0 0/0/0/0/0/0 0/0/0/0/0/0
Average 24h, 48h, 72h 0.33/0.33/0/0/0/0 0/0/0/0/0/0 0/0/0/0/0/0.67 0/0/0/0/0/0
Area effected <=25%/<=25%/0/0/0/0 -- -- --
Maximum average score (including area affected, max 110)        
Reversibility*) c/c/--/--/--/-- --/--/--/--/--/-- --/--/--/--/--/c --/--/--/--/--/--
Average time (unit) for reversion 48 hrs -- 48 hrs --
 
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In this study, 5,8-Dichlorchinizarin was not irritating to the eyes.
Executive summary:

In a primary eye irritation study performed in accordance with the Code of Federal Regulations, Title 16, Section 1500.41, 5,8-Dichlorchinizarin was instilled into the conjunctival sac of 6 albino rabbits (strain New Zealand White).  Animals then were observed for 7 days.  Irritation was scored by "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics", FDA, 1959, p.51.

Animals #1 and #2 showed opacity spots on cornea and clear iris within 48 hours of application (score 1). Animal #6 showed discharge at conjunctiva within 24 hours of application. All observed effects were fully reversible within 48 hours). No irritation occurred in any other animal during the entire observation period.

In this study, 5,8-Dichlorchinizarin is not an eye irritant.