Registration Dossier
Registration Dossier
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EC number: 231-308-5 | CAS number: 7491-09-0
Eye irritation
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 for cross-reference:
- read-across: supporting information
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Docusate sodium
- EC Number:
- 209-406-4
- EC Name:
- Docusate sodium
- Cas Number:
- 577-11-7
- Molecular formula:
- C20H38O7S.Na
- IUPAC Name:
- sodium 1,4-bis[(2-ethylhexyl)oxy]-1,4-dioxobutane-2-sulfonate
- Reference substance name:
- formulated product containing 70% Docusate sodium
- IUPAC Name:
- formulated product containing 70% Docusate sodium
- 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
Constituent 1
Constituent 2
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.
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