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EC number: 931-037-9 | 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was performed between 01 September 2005 and 04 September 2005.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Date of Inspection: 02/12/2002. Date of signature: 13/02/2003
Test material
- Reference substance name:
- dibarium(2+) bis(1,5-dioxo-1,5-bis(tridecyloxy)pentane-3-sulfonate) hydrogen phosphate
- EC Number:
- 931-037-9
- Molecular formula:
- Molecular formula for each combination of chain length. C13,13: (C30H57O7S)2 Ba @ BaHOP4 C11,12: (C27H51O7S)2 Ba @ BaHOP4 C12,12: (C28H53O7S)2 Ba @ BaHOP4 C12,13: (C29H55O7S)2 Ba @ BaHOP4 C13,14: (C31H59O7S)2 Ba @ BaHOP4 C14,14: (C32H61O7S)2 Ba @ BaHOP4
- IUPAC Name:
- dibarium(2+) bis(1,5-dioxo-1,5-bis(tridecyloxy)pentane-3-sulfonate) hydrogen phosphate
- Details on test material:
- Identification : Barium di(bistridecylsulfosuccinate) in mixture with barium hydrogen phosphate
Description : colourless waxy solid block
Batch number : Y-T-1
Storage conditions: room temperature in the dark
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Three New Zealand White rabbits were supplied by David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: twelve to twenty weeks old
- Weight at study initiation: At the start of the study the animals were in the weight range of 2.0 to 3.5 kg.
- Housing: The animals were individually housed in suspended cages.
- Diet (e.g. ad libitum): Free access to food (Certified Rabbit Diet (Code 5322) supplied by BCM IPS Limited, London, UK) was allowed throughout the study.
- Water (e.g. ad libitum): Free access to mains drinking water was allowed throughout the study.
The diet and drinking water were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
- Acclimation period: At least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): The temperature was set to achieve limits of 17 to 23°C.
- Humidity (%): The relative humidity was set to achieve limits of 30 to 70% .
Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study.
- Photoperiod (hrs dark / hrs light): The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
IN-LIFE DATES: From: Day 1 To: Day 3
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: On the day before the test each of a group of three rabbits was clipped free of fur from the dorsal/flank area using veterinary clippers. Only animals with a healthy intact epidermis by gross observation were selected for the study.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the test materia, moistened with 0.5 ml of distilled water.
- Concentration (if solution): Not applicable.
VEHICLE
- Amount(s) applied (volume or weight with unit): Not applicable.
- Concentration (if solution): Not applicable.
- Lot/batch no. (if required): Not applicable.
- Purity: Not applicable. - Duration of treatment / exposure:
- 4 hours.
- Observation period:
- 72 hours.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: On the day of the test a suitable test site was selected on the back of each rabbit.
- % coverage: Not stated.
- Type of wrap if used: A quantity of 0.5 g of the test material, moistened with 0.5 ml of distilled water, was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin. The patch was secured in position with a strip of surgical adhesive tape. To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset and the animals were returned to their cages for the duration of the exposure period.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: Four hours after application.
SCORING SYSTEM: Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored according to the following scale (please see below - Evaluation of skin reactions):
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- :Animal 93 (male)
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- :Animal 99 (male)
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0.66
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- : Animal 100 (male)
- Time point:
- other: Mean of 24, 48 and 72 hours.
- Score:
- 0.66
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- : Animal 93 (male)
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- : Animal 99 (male)
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- : Animal 100 (male)
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- The individual scores for erythema/eschar and oedema are given in Table 1.
Very slight erythema was noted at all treated skin sites one hour after patch removal and at the 24 hour observation and persisted at two treated skin sites at the 48-hour observation.
Very slight oedema was noted at two treated skin sites at the 24-hour observation.
One treated skin site appeared normal at the 48-hour observation and the remaining two treated skin sites appeared normal at the 72-hour observation. - Other effects:
- None.
Any other information on results incl. tables
Table1 Individual Skin Reactions
Skin Reaction |
Observation Time |
Individual Scores – Rabbit Number and Sex |
Total |
||
93 Male |
99 Male |
100 Male |
|||
Erythema/Eschar Formation |
1 Hour |
1 |
1 |
1 |
(3 ) |
24 Hours |
1 |
1 |
1 |
3 |
|
48 Hours |
0 |
1 |
1 |
( 2 ) |
|
72 Hours |
0 |
0 |
0 |
0 |
|
Oedema Formation |
1 Hour |
0 |
0 |
0 |
( 0 ) |
24 Hours |
0 |
1 |
1 |
2 |
|
48 Hours |
0 |
0 |
0 |
( 0 ) |
|
72 Hours |
0 |
0 |
0 |
0 |
|
Sum of 24 and 72-hour Readings (S): 5 |
|||||
Primary Irritation Index (S/6) : 5/6 = 0.8 |
|||||
Classification : MILD IRRITANT |
( ) = Total values not used for calculation of primary irritation index.
The test material did not meet the criteria for classification as a skin irritant according to EU classification and labelling regulations (Council Directive 67/548/EEC - Dangerous Substances Directive).
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material did not meet the criteria for classification as a skin irritant according to EU classification and labelling regulations (Council Directive 67/548/EEC - Dangerous Substances Directive).
- Executive summary:
Introduction.
The study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method was designed to meet the requirements of the following:
§ OECD Guidelines for the Testing of Chemicals No. 404 “Acute Dermal Irritation/Corrosion” (adopted 24 April 2002)
§ Method B4 Acute Toxicity (Skin Irritation) of Commission Directive 2004/73/EC
Results.
A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced very slight erythema and very slight oedema. One treated skin site appeared normal at the 48-hour observation and the remaining treated skin site appeared normal at the 72‑hour observation.
Conclusion.
The test material produced a primary irritation index of 0.8 and was classified as a mild irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
The test material did not meet the criteria for classification as a skin irritant according to EU classification and labelling regulations (Council Directive 67/548/EEC - Dangerous Substances Directive).
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