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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15 February and 01 March 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study undertaken at GLP accredited laboratory to internationally accepted guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
ODB-2
IUPAC Name:
ODB-2
Constituent 2
Chemical structure
Reference substance name:
6'-(dibutylamino)-3'-methyl-2'-(phenylamino)spiro[isobenzofuran-1(3H),9-(9H)-xanthen]-3-one
EC Number:
403-830-5
EC Name:
6'-(dibutylamino)-3'-methyl-2'-(phenylamino)spiro[isobenzofuran-1(3H),9-(9H)-xanthen]-3-one
Cas Number:
89331-94-2
Molecular formula:
C35 H36 N2 O3
IUPAC Name:
6'-(dibutylamino)-3'-methyl-2'-(phenylamino)-3H-spiro[2-benzofuran-1,9'-xanthen]-3-one
Details on test material:
- Name of test material (as cited in study report): ODB-2
- Substance type: Colour precursor for heat sensitive record sheets
- Physical state: white powder
- Analytical purity: > 99%
- Impurities (identity and concentrations): No data
- Purity test date: No data
- Lot/batch No.: 61-24101
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: Ambient in the dark
- Other: date received 26 January 1988

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Commercial laboratory animal supplier.
- Age at study initiation: 12 to 16 weeks
- Weight at study initiation: 2.9 to 3.7 kg.
- Housing: Metal cages with perforated floors.
- Diet: SDS standard rabbit diet, ad libitum
- Water: ad libitum
- Acclimation period: Acclimated but no other data.

ENVIRONMENTAL CONDITIONS
- Temperature: 19°C
- Humidity: 30 - 70%
- Air changes (per hr): 19
- Photoperiod: 12hrs dark / 12 hrs light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 40 mg
- Concentration (if solution):


Duration of treatment / exposure:
4 days
Observation period (in vivo):
4 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:

SCORING SYSTEM:
Cornea

Opacity: degree of density (area most dense taken for reading)

No ulceration or opacity 0
Scattered or diffuse areas of opacity (other
than slight dulling of normal lustre), details of iris clearly visible 1
Easily discernible translucent areas, details
of iris slightly obscured 2
Nacreous areas, no details of iris visible,
size of pupil barely discernible 3
Opaque cornea, iris not discernible through
the opacity 4

Iris

Normal 0
Markedly deepened rugae, congestion, swelling,
moderate circumcorneal hyperaemia or
injection, any of these or combination of
any thereof, iris still reacting to light
(sluggish reaction is positive) 1
No reaction to light, haemorrhage, gross
destruction (any or all of these) 2

Conjunctivae

Redness (refers to palpebral and bulbar conjunctivae cornea and iris)

Blood vessels normal 0
Some blood vessels definitely hyperaemic
(injected) 1
Diffuse, crimson colour, individual vessels
not easily discernible 2
Diffuse, beefy red 3

Chemosis (lids and/or nictitating membranes)

No swelling 0
Any swelling above normal (includes nictitating membranes) 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half-closed 3
Swelling with lids more than half-closed 4

TOOL USED TO ASSESS SCORE: hand-held torch

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
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation

Any other information on results incl. tables

Very slight conjunctival irritation was observed in all three animals at the one hour reading only. All eyes were completely normal the day after instillation of the test substance.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Instillation of ODB-2 into the rabbit eye did not elicit a positive response in any of the three treated animals according to OECD test
criteria.