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EC number: 204-889-8 | CAS number: 128-49-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- 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:
- No data are available for the registered substance, however data are available for the corresponding sodium salt of the substance, docusate sodium (CAS 577-11-7). These data are used for read-across to the registered substance calcium docusate (CAS 128-49-4). The presence of either of the counterions sodium or calcium is not considered to have an impact on the toxicity. It is therefore considered justified to use the data of the sodium salt for read across to the calcium salt of docusate.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
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
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 4
- Reversibility:
- not reversible
- 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:
No data are available for the registered substance, however data are available for the corresponding sodium salt of the substance, docusate sodium (CAS 577-11-7). These data are used for read-across to the registered substance calcium docusate (CAS 128-49-4). The presence of either of the counterions sodium or calcium is not considered to have an impact on the toxicity. It is therefore considered justified to use the data of the sodium salt for read across to the calcium salt of docusate.
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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