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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:
2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to OECD TG 405, EPA OPPTS 870.2400 and in accordance with the Principles of Good laboratory Practice (GLP).
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
Principles of method if other than guideline:
not applicable
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: dark green crystalline solid
Details on test material:
- Name of test material (as cited in study report): 1,4,5,8-Tetra (4'-n-butylphenylamino) Anthraquinone (TBPAAQ)
- Substance type: dark green crystalline solid
- Physical state: solid
- Analytical purity: > 97% active ingredient
- Lot/batch No.: Lot #020801; TD No. 02-045
- Expiration date of the lot/batch: 31 March 2004
- Stability under test conditions: expected to be stable for the duration of testing
- Storage condition of test material: room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Davidosn's Mill Farm, South Brunswick, NJ
- Age at study initiation: young adults
- Housing: singly housed in stainless steel caging with mesh floors
- Diet (e.g. ad libitum): Pelleted Purina Rabbit Chow #5326 approximately 150 grams daily
- Water (e.g. ad libitum): Filtered tap water was supplied ad libitum by automatic water dispensing system
- Acclimation period: 13 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22°C
- Humidity (%): 58-65%
- Photoperiod (hrs dark / hrs light): 12 hour lightldark cycle

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 ml (approximately 0.05 -0.06 grams)
Observation period (in vivo):
1, 24, 48 and 72 hours post instillation
Number of animals or in vitro replicates:
1 male + 2 female
Details on study design:
SCORING SYSTEM:ocular irritation was evaluated using a hig intensity whit elight (Mag Lite) according to Draize et al

TOOL USED TO ASSESS SCORE: fluorescein staining evaluation was performed prior to instillation and 24 hours post instillation to verify the absence of corneal damage.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritant / corrosive response data:
No corneal opacity or redness was noted for any treated eyes during the study. Approximately 24 hours after instillation, conjunctivitis was noted in one treated eye which reverted to normal within 48 hours. All animals were free of any ocular irritation within 48 hours.
Other effects:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the study and according to the Guidance to Regulation (EC) No. 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures, TBPAAQ will not be classified for eye irritation.
Executive summary:

A primary eye irritation test was conducted with rabbits to determine the potential for TBPAAQ to produce irritation from a single instillation via the ocular route.

One-tenth of a milliliter (approximately 0.05-0.06 grams) of the test substance was instilled into the conjunctival sac of the right eye of three healthy rabbits. The left eye remained untreated and served as a control. Ocular irritation was evaluated by the method of Draize et al.

No corneal opacity or iritis was noted for any treated eye during the study. Approximately 24 hours after instillation, conjunctivitis was noted in one treated eye which reverted to normal within 48 hours. All animals were free of any ocular irritation within 48 hours. Under the conditions of the study and according to the Guidance to Regulation (EC) No. 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures, TBPAAQ will not be classified for eye irritation.