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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:
1990-11-27 to 1990-12-04
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study. An updated OECD guideline 405 from 2012 is available; changes do not affect the reliability of this study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
(1981)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
84/449/EEC
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
4,7-methanooctahydro-1H-indene-diyldimethyl bis(2-carboxybenzoate)
EC Number:
407-410-2
EC Name:
4,7-methanooctahydro-1H-indene-diyldimethyl bis(2-carboxybenzoate)
Molecular formula:
C28H40O8
IUPAC Name:
2-[({5-[(2-carboxycyclohexanecarbonyloxy)methyl]tricyclo[5.2.1.0²,⁶]decan-8-yl}methoxy)carbonyl]cyclohexane-1-carboxylic acid; 2-[({8-[(2-carboxycyclohexanecarbonyloxy)methyl]tricyclo[5.2.1.0²,⁶]decan-4-yl}methoxy)carbonyl]cyclohexane-1-carboxylic acid
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): TCD-Emulgator
- Substance type: White solid
- Physical state: Solid
- Purity test date: 1990-04-26
- Lot/batch No.: 90003
- Expiration date of the lot/batch: 1992-01-08
- Storage condition of test material: At room temperature and in darkness
- pH: 5.0 (1 % in H2O)

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Interfauna U.K. Ltd., Wyton, Huntingdon, England
- Age at study initiation:
- Weight at study initiation: 3.5, 3.2, and 3.6 kg, all female
- Housing: Individually in stainless steel cages
- Diet (e.g. ad libitum): Standard diet "Ssniff K 4", approx. 100-120 g per animal and day (fed in the morning)
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): Approx. 50 %
- Air changes (per hr): Approx. 10/h
- Photoperiod (hrs dark / hrs light): 12/12 (illumination from 6 to 18 hrs CET)

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 µl (approx. 40 mg)
Duration of treatment / exposure:
24 h
Observation period (in vivo):
7 d
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Rinsing with saline
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize Grades

TOOL USED TO ASSESS SCORE: Hand-slit lamp, fluorescein

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:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.1
Max. score:
0.3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
Erythema
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
1.2
Max. score:
1.3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.1
Max. score:
0.3
Reversibility:
fully reversible

Any other information on results incl. tables

Results for the grading of irritating effects on the eye:

Animal no./ Sex

Body weight

Tissue

Signs

DRAIZE grades

Irritation index

1 h

24 h

48 h

72 h

7 d

14 d

21 d

M26/ Female

2.7 kg

Cornea

o

0

0

0

0

0

-

-

0.0

a

0

0

0

0

0

-

-

 

Fluorescein

i

-

1

1

0

-

-

-

 

a

-

1c

1p

0

-

-

-

 

Iris

 

0

0

0

0

0

-

-

0.0

Conjunctivae

r

1

1

1

1

0

 

 

1.0

s

1

0

0

0

0

 

 

0.0

Aqueous humour

 

0

0

0

0

0

-

-

 

Discharge

 

1

0

0

0

0

-

-

 

M25/ Female

2.9 kg

Cornea

o

0

0

0

0

0

-

-

0.0

a

0

0

0

0

0

-

-

 

Fluorescein

i

-

1

1

0

-

-

-

 

a

-

2c

1c

0

-

-

-

 

Iris

 

0

1

0

0

0

-

-

0.3

Conjunctivae

r

1

2

1

1

0

-

-

1.3

s

2

1

0

0

0

 

 

0.3

Aqueous humour

 

0

0

0

0

0

-

-

 

Discharge

 

3

0

0

0

0

-

-

 

K8/ Female

3.4 kg

Cornea

o

0

0

0

0

0

-

-

0.0

a

0

0

0

0

0

-

-

 

Fluorescein

i

-

0

-

-

-

-

-

 

a

-

0

-

-

-

-

-

 

Iris

 

0

0

0

0

0

-

-

0.0

Conjunctivae

r

1

2

1

1

0

-

-

1.3

s

1

0

0

0

0

 

 

0.0

Aqueous humour

 

0

0

0

0

0

-

-

 

Discharge

 

1

0

0

0

0

-

-

 

o: Opacity

a: Area

i: Intensity

r: Redness

s: Swelling

-: Not examined

c: Confluent diffuse areas

p: Scattered punctate

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The eye irritant/corrosive potential of the test item was assessed in rabbits according to OECD guideline 405 and EU method B.5. The test substance induced slight reactions of the mucous membranes and mild corneal effects which were fully reversible within 7 days. The substance is regarded as slightly irritating.
Executive summary:

In a primary eye irritation study in accordance with OECD guideline 405 and EU method B.5, 100 µl of TCD-emulsifier was instilled into the conjunctival sac of adult rabbits (strain: HC:NZW) (3 female) for 24 hours. The eyes were rinsed with saline after 24 h of exposure. Animals then were observed for 7 days. Irritation was scored by the method of DRAIZE.

The exposure induced slight reactions of the mucous membranes and mild corneal effects which were fully reversible within 7 days. Based on the study results, the test item is not classified as an eye irritant according to CLP Annex I.