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EC number: 209-406-4 | CAS number: 577-11-7
- 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
Endpoint summary
Administrative data
Description of key information
Both for the skin and eye irritation, in vivo key studies according to OECD 404 and 405 were available, demonstrating that the test substance is highly irritating to skin and resulting in irreversible eye damage. The overall irritation scores were 7.8 of max. 8 (1- 72 h) in the key study for skin irritation and 47 of max. 110 (1-72 h) in the key study for eye irritation. This information in combination with supporting studies resulted in skin irritation EU GHS category 2 and eye damage EU GHS category 1.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin 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.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: White Russian, Chbb-SPF
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Fa.Dr. Karl Thomae GmbH, Biberach
- Weight at study initiation: 2,2 - 2,3kg
- Housing: separate in stainless steel cages
- Diet : KZ Alleindiät für Kaninchen, Ssniff Spezialfutter GmbH, 4770 Soest, ad libitum
- Water : public supply, ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20°C +-1°C
- Humidity:60% +-5%
- Air changes (per hr): 15 air replacements/hour
- Photoperiod (hrs dark / hrs light): 12 /12
IN-LIFE DATES: From: 1988-02-23 To: 1988-03-08 - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0,5 mL undiluted
- Concentration (if solution): 70% Docusate sodium - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours; 6, 8, 10 and 14 days
- Number of animals:
- 3 male
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm3
- % coverage:
- Type of wrap if used: polyethylene film (6X6 cm) which was secured in position by means of
an elastic bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Warm water
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to OECD 404: See Table 1 - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1h, 24h, 48h, 72h
- Score:
- 7.8
- Max. score:
- 8
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: Score = sum of erythema & oedema
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- other: effects still visible at 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- other: effects still visible at 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- other: effects still visible at 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- other: effects still visible at 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- other: effects still visible at 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- other: effects still visible at 14 days
- Irritant / corrosive response data:
- Strongly irritating
- Interpretation of results:
- Category 2 (irritant)
- Remarks:
- Criteria used for interpretation of results: other: EU GHS
- Conclusions:
- Irriation index = 7.8/8.
- Executive summary:
A volume of 0.5 mL Docusate sodium (70% solution in ethanol/methanol and water) was applied according to OECD 404 on 6 cm2 shaved skin of 3 male rabbits by occlusive application. After this period, the skin area was washed with warm water and observed after 1, 24, 48, 72 hours and 6, 8, 10 and 14 days. The results showed that there was an irritation index of 7.8/8 over the 1 -72 hour period and effects were still visible at 14 days.
Reference
Table 1. Dermal irritation scores and observations
Animal No. (Ear No.) |
Sex |
Response |
1 hour |
24 hours |
48 hours |
72 hours |
6 days |
8 days |
10 days |
14 days |
1 (51227) |
M |
Erythema |
3 x |
4 xV |
4 xVP |
4 xVP |
WScp |
WScp |
WScp |
Na |
Oedema |
4 |
4 |
4 |
4 |
||||||
2 (51231) |
M |
Erythema |
3 x |
4 xV |
4 xVP |
4 xVP |
WScp
|
WScp
|
Scp
|
Scp iA
|
Oedema |
4 |
4 |
4 |
4 |
||||||
3 (51371) |
M |
Erythema |
3 x |
4 xV |
4 xVP |
4 xVP |
WScp |
WScp
|
Scp |
Scp abgelöst Na |
x= yellow coloration in applicated area (Gelbfärbung im Applikationsbereich)
V= hardening in applicated area(Verhärtung im Applikationsbereich)
W= wavily, can be imprinted (Wellig, last sich eindrücken)
P= perkamen-like (pergamentartig)
Scp=crust (Schorfplatte)
blNa= bloody scars (bluttige Narben)
Na=Scars (Narben)
Ri= Cracked (rissig)
iA= In replacement (in Ablösung)
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- 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.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
- 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 - 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 - 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
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 17 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 17 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: mean of 17 and 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: mean of 17 and 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritant / corrosive response data:
- See Tables 1, 2 and 3.
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- 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.
Reference
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
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
A key study for skin irritation was performed in rats according to OECD 404 test guideline, which was considered to be reliable, adequate and relevant (Elementis, Mürmann 1988). A volume of 0.5 mL Docusate sodium (70% solution in ethanol/methanol and water) was applied on 6 cm2 shaved skin of 3 male rabbits by occlusive application. After this period, the skin area was washed with warm water and observed after 1, 24, 48, 72 hours and 6, 8, 10 and 14 days. The results showed that there was an irritation index of 7.8/8 over the 1 -72 hour period and some effects were still visible at 14 days.
A support study was conducted by application of 0.5 mL Docusate sodium to intact and abraded skin of 6 male rabbits according to FHSA (Federal Hazard Act Substance) and CFR 1500.41 method for 24 hours under occlusive dressing (Cytec, McGinty 1977a). The reactions were evaluated after 24 and 72 hours and the substance was strongly irritating as indicated by a mean primary irritation score of 3.83/4. There was one other exploratory study in 2 rabbits which were exposed for 24 hours and evaluated after 24 and 72 hours, also showing eye irritating up to 72 hours (Dow, Rohm & Haas1974). As the latter study was exploratory, this was disregarded for the safety evaluation.
A key study for eye irritation was conducted with Docusate sodium according to OECD 405 test guideline, which was considered to be reliable, adequate and relevant (Elementis, Mürmann 1988). A volume of 0.1 mL Docusate sodium (mixture of 70% docusate sodium, ethanol in methanol, water) was applied to the eyes of 3 male rabbits. After 72 hours, fluorescein solution was applied for cornea evaluation and rinsing was performed with warm physiological solution. Evaluation after 1, 24, 48 and 72 hours and 6, 8, 10, 13, 17 and 21 days after application showed irreversible damage (including turbidity of the cornea). The mean overall irritation score for 1 -72 hours was 46,67/110.
A support study was conducted by application of a volume of 0.1 mL (0.1g) Docusate sodium to the eyes of 6 rabbits according to FHSA (Federal Hazard Substance Act) and CFR 1500.41 method. Evaluation after 24, 48 and 72 hours showed that the substance was irritating as indicated by changes of the cornea, iris and conjunctiva up to 72 hour (Cytec, McGinty 1977a). There was one other exploratory study in 2 rabbits which were evaluated after 24, 48 and 72 hours, also showing eye irritating up to 72 hours (Dow, Rohm & Haas 1974). As the latter study was exploratory, this was disregarded for the safety evaluation.
In summary, both skin and eye irritation studies were available showing that Docusate sodium is irritating to skin and resulting in irreversible eye damage, resulting in the need for classification and labeling.
Effects on skin irritation/corrosion: highly irritating
Effects on eye irritation: corrosive
Justification for classification or non-classification
Based on the strong skin irritation (EU GHS category 2) and irreversible eye damage (EU GHS category 1), classification is warranted.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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