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Diss Factsheets
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EC number: 941-224-7 | CAS number: -
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated 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.
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 404 (Acute Dermal 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
70% Docusate sodium
15% Ethanol (diluted with 5% Methanol)
15% Water
Constituent 1
Constituent 2
Test animals
- 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
Test system
- 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
Results and discussion
In vivo
Results
- 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
- Irritant / corrosive response data:
- Stronly irritating
Any other information on results incl. tables
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)
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant)
- Remarks:
- Migrated information 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.
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