Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to internationally accepted test guidelines. As the test material also contains ethanol and methanol, these ingredients may have potential influence on the irritation score.
Justification for type of information:
Data has been read across from a structurally similar substance in a category approach. See further discussion in the read across justification attached.
Cross-reference
Reason / purpose:
read-across: supporting information

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): MARLINAT DF 8
- Physical state: liquid, clear
- Analytical purity: 70% Docusate sodium
- Composition of test material, percentage of components:
70% Docusate sodium
15% Ethanol (diluted with 5% Methanol)
15% Water

Test animals / tissue source

Species:
rabbit
Strain:
other: White Russian, Chbb-SPF
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source:Fa. Dr. Karl Thomae GmbH, Binerach
- Weight at study initiation: 2,2 - 2,6 kg
- Housing: Stainless Steel cages
- Diet (e.g. ad libitum): K4 Alleindiät für Kaninchen, Ssniff Spezialfutter GmbH, 4770 Soest, ad libitum
- Water (e.g. ad libitum): public supply, ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20°C +- 1°C
- Humidity: 60% +- 5%
- Air changes (per hr): 15 air changes / hour
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1988-02-23 To: 1988-03.15

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: same animals, left eye as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0,1 mL
- Concentration (if solution): 70% Diisoctylsulfosuccinat-Natriumsalz
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
1, 24, 48 and 72 hours; 6, 8, 10, 13, 17 and 21 days
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE (eye irritation 1206)
- Washing (if done): warm physiological NaCl solution
- Time after start of exposure: 72 hours

SCORING SYSTEM: after Draize

TOOL USED TO ASSESS SCORE: sodium fluorescein solution and eye lamp

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1h, 24h, 48h, 72h
Score:
ca. 47
Max. score:
110
Reversibility:
not reversible
Remarks on result:
other: MARLINAT DF 8
Irritant / corrosive response data:
See Tables 1, 2 and 3.

Any other information on results incl. tables

Table 1: Cornea evaluation

Rabbit   Ear No.

Sex

Response

1 hour

24 hours

48 hours

72 hours

6 days

8 days

10 days

13 days

17 and 21days

51197

M

T

1

1

2

2

2

2

2

3

3

R

4

4

4

4

3

3

2

1

1

TxRx5

20

20

40

40

30

30

20

15

15

51251

M

T

1

1

2

2

2

2-

2

3

3

R

4

4

4

4

3

2

2

1

1

TxRx5

20

20

40

40

30

20

20

15

15

51255

M

T

1

1

2

2

2

2 *

2 *

2

3

R

4

4

4

4

4

4

4

4

3

TxRx5

20

20

40

40

40

40

40

40

45

 

 

x absolut

20,00

20,00

40,00

40,00

33,33

30,00

26,67

23,33

25,00

T= Turbidity

R= Range of turbidity

* clear white ring on the pupil

 

Table 2: Iris evaluation

Rabbit   Ear No.

Sex

Response

1 hour

24 hours

48 hours

72 hours

6 days

8 days

10 and 13 days

17 and 21 days

51197

M

T

1 x

1*

1 x

1 x

1 xc

1c

1c

1c

Tx5

5

5

5

5

5

5

5

5

51251

M

T

1 x

1 *

1 *

1 *

1 *c

1 xc

1 c

1 c st

Tx5

5

5

5

5

5

5

5

5

51255

M

T

1 x

1 x

1 x

1 *

1 *c

1 *c

1 xc

1 c st

Tx5

5

5

5

5

5

5

5

5

 

 

x absolute

5,00

5,00

5,00

5,00

5,00

5,00

5,00

5,00

T= Change

x= iris turned partially red

*= iris turned clearly red

c= circumcorneal injection

st= strong

 

Table 3: Conjunctiva evaluation

Rabbit   Ear No.

Sex

Response

1 hour

24 hours

48 hours

72 hours

6 days

8 days

10 days

13 days

17 and 21 days

51197

M

A

2

3

3 +b

3 +b

2

2

1

1

0

B

1

1

1

1

1

1

0

0

0

C

3

3

2

2

0

0

0

0

0

(A+B+C)x2

12

14

12

12

6

6

2

2

0

51251

M

A

2

3

3 +

3 +

2

2

2

2

0

B

1

1

1

1

1

1

1

1

0

C

2

2

0

0

1

0

0

0

0

(A+B+C)x2

10

12

8

8

8

6

6

6

0

51255

M

A

2

3

3 +

3 +

2

2

2

1

1

B

1

1

1

1

1

1

0

0

0

C

3

3

2

3

0

0

0

0

0

(A+B+C)x2

12

14

12

14

6

6

4

2

2

 

 

x absolut

11,33

13,33

10,67

11,33

6,67

6,00

4,00

3,33

0,67

A= Erythema

B= Oedema

C= Exsudation

b=bloody secretion

+= epidermis and mucosa hemorrhagic, slightly corroded

 

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: other: EU GHS
Conclusions:
Irritation index = 46,67/110.
Executive summary:

A volume of 0.1 mL Docusate sodium (70% solution in ethanol/methanol and water) was applied unilaterally in the eyes of 3 male rabbits according to OECD 405 method. After 72 hours, fluorescein solution was applied for cornea evaluation and rinsing was performed with warm physiological solution. Evalution after 1, 24, 48 and 72 hours and 6, 8, 10, 13, 17 and 21 days after application showed irriversible damage (including turbidity of the cornea). The mean overall irritation score for 1 -72 hours was 46,67/110.