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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:
19.-23.10.2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study was carried out in accordance with internationally valid GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Batch No.: V 1161
Purity: main component: 9,10-Anthraquinone 98.9 wt.%
Significant impurities: Anthracene 0.01 wt.%, 2,3-Naphthalic anhydride 0.25%, Naphtho[2,3-b]thiphenquinone 0.33%, 1,4- Anthraquinone 0.32%
Appearance: Yellow crystalline powder
Expiration date: 06/2024
Storage: The test substance was stored in the dark place at laboratory temperature during the study.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: breeding farm VELAZ s.r.o., Koleč u Kladna, Czech Republic, RČH CZ 21760152
- Age at study initiation: 4 – 5 months
- Weight at study initiation: 2.5 – 3.0 kg
- Housing: Conventional animal room – individually in metallic cages
- Diet: Standard pelleted diet TM-MAK 1 for rabbits and guinea pigs ad libitum
- Water: Drinking tap water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Room temperature: 20 +/- 3°C, permanently monitored
- Humidity (%): Relative humidity: 30 – 70%, permanently monitored
- Air changes (per hr): approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): Light period: 12 hour light/12 hour dark

STUDY TIME SCHEDULE:
Animal supply: 30. 09. 2009
Experimental part of study: 19. 10. – 23. 10. 2009

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0,1 g
-The test substance was used in delivered form and it was measured out immediately before application.


Duration of treatment / exposure:
24 hours
Observation period (in vivo):
1, 24, 48 and 72 hours after application and then daily
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: According to the grading system given in Method B.5 Acute Toxicity: Eye Irritation/Corrosion, Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008.

TOOL USED TO ASSESS SCORE: fluorescein and ophthalmoscopy

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Rabbit No. 10:
strong lacrimation was observed 1 hour after application
1 hour: Conjunctivae – some blood vessels hyperaemic (injected)
Chemosis – no alterations
Cornea – no alterations
Iris – no alterations
24 hours: No alterations
48 hours: No alterations
72 hours: No alterations


Rabbit No. 11:
1 hour: Conjunctivae – diffuse, crimson colour, individual vessels not easily discernible
Chemosis – no alterations
Cornea – no alterations
Iris – no alterations
24 hours: Conjunctivae – some blood vessels hyperaemic (injected)
48 hours: No alterations
72 hours: No alterations

Rabbit No. 12:
1 hour: Conjunctivae – diffuse, crimson colour, individual vessels not easily discernible
Chemosis – someswelling above normal Lacrimation
24 hours: Conjunctivae – some blood vessels hyperaemic (injected)
48 hours: No alterations
72 hours: No alterations

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The changes described further were observed on eye of animals. The effects were detected at all three animals at 1 hour after application, in two animal the lesions persisted to 24 h after application.
Changes at 1 hour after application: redness of conjunctivae – diffuse, crimson colour, individual vessels not easily discernible; chemosis – some swelling above normal.
Changes at 24 hours after application: conjunctivae – some blood vessels hyperaemic (injected).
Changes at 48 hours after application: no alterations
No clinical signs of systemic intoxication were detected.
Examination of eye irritation after single application demonstrated, that the test substance, Anthraquinone, is not irritating for eye of rabbit.
Executive summary:

The test substance, Anthraquinone, was tested for the assessment of eye irritation/corrosion effects using albino rabbit (New Zealand Albino breed).

 

The test was performed according to the Method B.5 Acute Toxicity: Eye Irritation/Corrosion. Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008.

The test was performed initially using one animal. Because a corrosive effect was not observed in initial test, the response was confirmed using two additional animals.

 

The changes described further were observed on eye of animals. The effects were detected at all three animals at 1 hour after application, in two animal the lesions persisted to 24 h after application.

Changes at 1 hour after application: redness of conjunctivae – diffuse, crimson colour, individual vessels not easily discernible; chemosis – some swelling above normal.

Changes at 24 hours after application: conjunctivae – some blood vessels hyperaemic (injected).

Changes at 48 hours after application: no alterations

No clinical signs of systemic intoxication were detected.

 

Examination of eye irritation after single application demonstrated, that the test substance, Anthraquinone, is not irritating for eye of rabbit.

 

The classification of the test substance eye irritation/corrosion effect was performed according to Directive 67/548/EEC, Annex VI (part 3.2.6.2.)

 

Based on the test results and according to the EC criteria for classification and labelling of dangerous substances and preparations the test substance does not have to be classified for eye irritation/corrosion and has no obligatory labelling requirement for eye irritation/corrosion.