Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to GLP and valid testing guidelines, therefore it is considered relevant, adequate and reliable for classification.

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Netzer SB 10, sulfobernsteinsäureester-Natriumsalz, Di-isodecylsulfobernsteinsäureester-mono-natriumsalz
- Physical state: Almost colorless, clear liquid
- Analytical purity: 63.0-67.0%
- Impurities (identity and concentrations): See confidential details
- Composition of test material, percentage of components: See confidential details
- Purity test date: Not provided
- Lot/batch No.: E06 124 505 (produced 1985-07-03)
- Expiration date of the lot/batch: Not provided
- Stability under test conditions: Not provided
- Storage condition of test material: In the dark, at 22°C

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, conventional breeding
- Age at study initiation: Ca. 3-5 months
- Weight at study initiation: 2.3-3.0 kg
- Fasting period before study: Not provided
- Housing: Individual cages
- Diet (e.g. ad libitum): Altromin 2123 Haltungsdiät- Kaninchen, Altromin GmbH, Lage/Lippe, ad libitum as well as hay (ca. 15 g täglich)
- Water (e.g. ad libitum): Deionized, chlorinated water from automatic drinkers, ad libitum
- Acclimation period: Not provided

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 50 ± 20%
- Air changes (per hr): Not provided
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
single application
Observation period (in vivo):
72 hours (1, 24, 48 and 72h after application) and 14 days (7 and 14 days after application) in addition for the positive findings
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with physiological saline solution
- Time after start of exposure: 24 h after application and at all observation points


SCORING SYSTEM: See under “Any other information on material and methods incl. tables”

TOOL USED TO ASSESS SCORE: fluorescein (at 24 and 72 hours and for positive findings at 7 and 14 days))

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
1.4
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
2.6
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritant / corrosive response data:
One to 72 hours after application, the conjunctivae showed a diffuse bright red color and a very clear swelling to a swelling with more than half-closed lids. The iris was red, the cornea showed diffuse opacity areas to easily discernible translucent areas. 7 Days after application significant hyperemia of some blood vessels to diffuse crimson-red colored conjunctivae and very slightly to significantly swollen conjunctivae were observed. One animal showed scattered areas of opacity of the cornea. 14 Days after application all signs of irritation were reversible. One hour to 7 days after application, the irritation was accompanied with a clear, colorless or white mucous discharge. One animal showed 24 hours to 7 days after application partially white discolorations, bleeding and detachments of parts of the conjunctivae and nictitating membrane.

Any other information on results incl. tables

Table 2. Individual findings

Time after application

1h

24h

48h

72h

7d

14d

Animal No.

1

2

3

1

2

3

1

2

3

1

2

3

1

2

3

1

2

3

 

Conjunctivae chemosis

3

3

2

3

2

2

4

2

3

4

2

1

2

1

1

0

0

0

Conjunctivae redness

3

3

3

3

3

3

3

3

3

3

3

3

2

1

1

0

0

0

Iris

1

1

1

1

1

1

1

1

1

1

1

1

0

0

0

0

0

0

Cornea opacity

1

0

1

1

1

2

2

1

2

2

1

1

1

0

0

0

0

0

Fluorescein Test*

 

 

 

4

4

3

 

 

 

3

1

1

1

0

0

0

0

0

 

Eye discharge

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

- clear, colorless

x

x

x

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

-white, mucous

 

 

 

x

x

x

x

x

x

x

x

x

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conjunctivae

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

- white discoloration

 

 

 

x

 

 

x

 

 

x

 

 

x

 

 

 

 

 

- detachment of part

 

 

 

 

 

 

x

 

 

x

 

 

x

 

 

 

 

 

- with bleeding

 

 

 

 

 

 

 

 

 

 

 

 

x

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Iris

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

-reddened

x

x

x

x

x

x

x

x

x

x

x

x

 

 

 

 

 

 

  *Indicated is the area of whitening of the corneal surface under UV light after instillation of a drop of fluorescein sodium (0.01%)

0= no whitening

1= punctiform to 1/4

2= more than 1/4 to 1/2

3= more than 1/2 to 3/4

4= more than 3/4 to 4/4

 

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on this study and taking into account any other eye changes the test item is classified as irritant according to the classification criteria of Directive 83/467/EEC and the Hazardous Substances Regulation and is labeled R 36- irritating to the eyes.
Executive summary:

Three New Zealand White rabbits underwent a single application in the conjunctival sac of the left eye of 0.1 mL of the test item. The untreated eye served as a control. 24 Hours after administration of the test item as well as to all other assessment time points at which, the treated eyes still showed discharges or in which a corneal examination with fluorescein sodium solution was done, the treated eyes were thoroughly washed with physiological saline solution (ca. 37°C).
The assessments of the eyes were made 1, 24, 48 and 72 hours after instillation. In addition the cornea was also examined under UV light, after instillation of a drop of fluorescein sodium solution, at the assessment time points 24 and 72 hours. Damage to the cornea, iris and conjunctivae were scored numerically. Mean 24 -72h scores were 1.4/4 for cornea, 1/2 for iris, 3/3 for conjuctiva and 2.6/4 for chemosis. All other changes were recorded. Because eye effects were still present at 72 hours, an additional assessment was carried out after 7 and 14 days.
One to 72 hours after application, the conjunctivae showed a diffuse bright red color and a very clear swelling to a swelling with more than half-closed lids. The iris was red, the cornea showed diffuse opacity areas to easily discernible translucent areas. 7 Days after application significant hyperemia of some blood vessels to diffuse crimson-red colored conjunctivae and very slightly to significantly swollen conjunctivae were observed. One animal showed scattered areas of opacity of the cornea. 14 Days after application all signs of irritation were reversible. One hour to 7 days after application, the irritation was accompanied with a clear, colorless or white mucous discharge. One animal showed 24 hours to 7 days after application partially white discolorations, bleeding and detachments of parts of the conjunctivae and nictitating membrane.