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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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was performed between 19 June 2008 and 03 July 2008
- 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:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Date of inspection: 21/08/2007 Date of Signature:15/10/2007
- Test type:
- fixed dose procedure
- Limit test:
- yes
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:
- - Name of test material (as cited in study report): Barium di(bistridecylsulfosuccinate) in mixture with Barium hydrogen phosphate
- Substance type: pale yellow solid
- Physical state: Solid
-Batch number: Y-T-1
- Storage condition of test material: room temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Age at study initiation: At the start of the study the animals were eight to twelve weeks of age.
- Weight at study initiation: At the start of the study the animals weighed at least 200g.
- Fasting period before study: Overnight fasting immediately before dosing and for approximately three to four hours after dosing.
- Housing: The animals were housed in groups of three in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum): Certified Rat and Mouse Diet) was allowed throughout the study. The diet was routinely analysed and were considered not to contain any contaminants that would reasonably be expected to affect the purpose or integrity of the study.
- Water (e.g. ad libitum): Free access to mains drinking water. The water was routinely analysed and were considered not to contain any contaminants that would reasonably be expected to affect the purpose or integrity of the study.
- Acclimation period: At least five days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Set to achieve limits of 19 deg C to 25 deg C.
- Humidity (%): Set to achieve limits of 30 to 70%.
- Air changes (per hr): The rate of air exchanges was at least fifteen changes per hour.
- Photoperiod (hrs dark / hrs light): Light 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 0 To: Day 14
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- arachis oil
- Details on dermal exposure:
- TEST SITE
- Area of exposure: On the day before treatment the back and flanks of each animal were clipped free of hair. The appropriate amount of test material, moistened with arachis oil BP, was applied as evenly as possible to an area of shorn skin.
- % coverage: approximately 10% of the total body surface area
- Type of wrap if used: A piece of surgical gauze was placed over the treatment area and semi-occluded with a piece of self adhesive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the 24-hour contact period the bandage was carefully removed and the treated skin and surrounding hair wiped with cotton wool moistened with arachis oil BP to remove any residual test material.
- Time after start of exposure:24-hour
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):Not stated
- Concentration (if solution): treated with the test material at a dose level of 2000 mg/kg.
- Constant volume or concentration used: yes
- For solids, paste formed: Test material was moistened with arachis oil BP prior to application
VEHICLE
- Amount(s) applied (volume or weight with unit): Not stated
- Concentration (if solution):Not stated
- Lot/batch no. (if required): Not Stated
- Purity:Not stated - Duration of exposure:
- 24 hour exposure period
- Doses:
- dose level of 2000 mg/kg
- No. of animals per sex per dose:
- Five males at 2000 mg/kg
Five females at 2000 mg/kg - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:The animals were observed for deaths or overt signs of toxicity ½, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days. Individual bodyweights were recorded prior to application of the test material on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
At the end of the study the animals were killed by cervical dislocation. All animals were subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained. - Statistics:
- Data evaluations included the relationship, if any, between the exposure of the animal to the test material and the incidence and severity of all abnormalities including behavioural and clinical observations, gross lesions, bodyweight changes, mortality and any other toxicological effects.
Using the mortality data obtained, an estimate of the acute dermal median lethal dose (LD50) of the test material was made.
Results and discussion
- Preliminary study:
- Not applicable
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: 95% CL not stated
- Mortality:
- There were no deaths.
- Clinical signs:
- other: There were no signs of systemic toxicity.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- Dermal Reactions:
Individual dermal reactions are given in the tables below:
Moderate to severe erythema was noted at the treatment site of one female, well-defined erythema was noted at the treatment sites of six animals and very slight erythema was noted at the treatment sites of the remaining animals one day after dosing. Very slight erythema was noted at the treatment sites of all males and three females two and three days after dosing and in one male four days after dosing.
Small superficial scabs were noted at the treatment sites of all females up to 14-days after dosing. Crust formation was noted at the treatment site of one female four days after dosing and two females five days after dosing. Other skin reactions noted at the treatment sites of two females up to 14-days after dosing were hardened, light brown colored scab and scab lifting to reveal glossy skin. Adverse skin reactions prevented accurate evaluation of erythema and oedema at the treatment sites of two females, two to four days after dosing, and persisted in one female, five days after dosing.
The treatment sites of male animals appeared normal four or five days after dosing and the treatment sites of two females appeared normal six days after dosing.
Any other information on results incl. tables
Table Individual Dermal Reactions - Males
Dose Level mg/kg |
Animal Number and Sex |
Observation |
Effects Noted After Initiation of Exposure (Days) |
|||||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
|||
2000 |
1-0 Male |
Erythema |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Other |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
1-1 Male |
Erythema |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Other |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
1-2 Male |
Erythema |
2 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Other |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
1-3 Male |
Erythema |
2 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Other |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
1-4 Male |
Erythema |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Other |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0= No reactions
Table Individual Dermal Reactions - Females
Dose Level mg/kg |
Animal Number and Sex |
Observation |
Effects Noted After Initiation of Exposure (Days) |
|||||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
|||
2000 |
2-0 Female |
Erythema |
2 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Other |
0 |
Ss |
Ss |
Ss |
Cf |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
2-1 Female |
Erythema |
2 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Other |
0 |
Ss |
Ss |
Cf |
Cf |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
2-2 Female |
Erythema |
2 |
?e |
?e |
?e |
?e |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Oedema |
0 |
?od |
?od |
?od |
?od |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Other |
0 |
Sp |
Sp |
Sp |
Sg |
Ss |
Ss |
Ss |
Ss |
SsSg |
SsSg |
SsSg |
SsSg |
SsSg |
||
2-3 Female |
Erythema |
2 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Other |
0 |
0 |
0 |
Ss |
Ss |
Ss |
Ss |
Ss |
Ss |
Ss |
Ss |
Ss |
Ss |
Ss |
||
2-4 Female |
Erythema |
3 |
?e |
?e |
?e |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Oedema |
0 |
?od |
?od |
?od |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Other |
0 |
Sp |
Sp |
Sp |
SsSg |
SsSg |
SsSg |
SsSg |
SsSg |
SsSg |
SsSg |
SsSg |
SsSg |
SsSg |
0= No reactions
Cf = Crust formation
Ss = Small, superficial scattered scabs
Sp = Hardened, light brown coloured scab
Sg = Scab lifting to reveal glossy skin
?e = Adverse reactions prevent evaluation of erythema
?od = Adverse reactions prevent evaluation of oedema
Table Individual Bodyweights and Weekly Bodyweight Changes
Dose Level mg/kg |
Animal Number and Sex |
Bodyweight (g) at Day |
Bodyweight Change (g) During Week |
|||
0 |
7 |
14 |
1 |
2 |
||
2000 |
1-0 Male |
244 |
291 |
353 |
47 |
62 |
1-1 Male |
253 |
298 |
3 58 |
45 |
60 |
|
1-2 Male |
254 |
318 |
374 |
64 |
56 |
|
1-3 Male |
236 |
272 |
311 |
36 |
39 |
|
1-4 Male |
248 |
289 |
333 |
41 |
44 |
|
2-0 Female |
256 |
271 |
283 |
15 |
12 |
|
2-1 Female |
213 |
225 |
232 |
12 |
7 |
|
2-2 Female |
247 |
261 |
261 |
14 |
0 |
|
2-3 Female |
229 |
258 |
268 |
29 |
10 |
|
2-4 Female |
223 |
249 |
260 |
26 |
11 |
The acute dermal median lethal dose (LD50) of the test material in the Sprague‑Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute dermal median lethal dose (LD50) of the test material in the Sprague Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight.
- Executive summary:
Introduction. The study was performed to assess the acute dermal toxicity of the test material in the Sprague‑Dawley CD strain rat. The method was designed to meet the requirements of the following:
§ OECD Guidelines for the Testing of Chemicals No. 402 “Acute Dermal Toxicity” (adopted)
§ Method B3 Acute Toxicity (Dermal) of Commission Directive 92/69/EEC
Method. A group of ten animals (five males and five females) was given a single, 24-hour, semi‑occluded dermal application of the test material to intact skin at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.
Mortality. There were no deaths.
Clinical Observations. There were no signs of systemic toxicity.
Dermal Irritation. Very slight to moderate to severe erythema was noted at the treatment sites of all animals. Other skin reactions noted at the treatment sites of females were crust formation, small superficial scabs, hardened, light brown coloured scab and scab lifting to reveal glossy skin. Adverse skin reactions prevented accurate evaluation of erythema and oedema at the treatment sites of two females. The treatment sites of male animals appeared normal four or five days after dosing and the treatment sites of two females appeared normal six days after dosing.
Bodyweight. Animals showed expected gains in bodyweight over the study period except for one female which showed expected gain in bodyweight during the first week but no gain in bodyweight during the second week.
Necropsy. No abnormalities were noted at necropsy.
Conclusion. The acute dermal median lethal dose (LD50) of the test material in the Sprague‑Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight.
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