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EC number: 284-902-1 | CAS number: 84989-13-9
- 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:
- 03 July 2018 - 08 August 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Guideline study performed under GLP. All relevant validity criteria were met.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 09 October 2017
- Deviations:
- yes
- Remarks:
- The deviation was considered to have not affected the integrity or validity of the study
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Benzenesulfonic acid, 4-sec-decyl, ammonium salts
- Molecular formula:
- C16H29NO3S
- IUPAC Name:
- Benzenesulfonic acid, 4-sec-decyl, ammonium salts
- Reference substance name:
- Benzenesulfonic acid, 4-sec-undecyl, ammonium salts
- Molecular formula:
- C17H31NO3S
- IUPAC Name:
- Benzenesulfonic acid, 4-sec-undecyl, ammonium salts
- Reference substance name:
- Benzenesulfonic acid, 4-sec-dodecyl, ammonium salts
- Molecular formula:
- C18H33NO3S
- IUPAC Name:
- Benzenesulfonic acid, 4-sec-dodecyl, ammonium salts
- Reference substance name:
- Benzenesulfonic acid, 4-sec-tridecyl, ammonium salts
- Molecular formula:
- C19H35NO3S
- IUPAC Name:
- Benzenesulfonic acid, 4-sec-tridecyl, ammonium salts
- Test material form:
- other: Highly viscous light yellow liquid
- Details on test material:
- Storage Conditions: Highly viscous light yellow liquid
Constituent 1
Constituent 2
Constituent 3
Constituent 4
- Specific details on test material used for the study:
- RADIOLABELLING INFORMATION (if applicable): N/A
- Radiochemical purity:
- Specific activity:
- Locations of the label:
- Expiration date of radiochemical substance:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL:
- Storage condition of test material: At room temperature in the dark
- Stability under test conditions:
- Solubility and stability of the test substance in the solvent/vehicle:
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:
TREATMENT OF TEST MATERIAL PRIOR TO TESTING: Tested undiluted
- Treatment of test material prior to testing:
- Preliminary purification step (if any):
- Final dilution of a dissolved solid, stock liquid or gel:
- Final preparation of a solid:
FORM AS APPLIED IN THE TEST (if different from that of starting material): N/A
OTHER SPECIFICS: N/A
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS (UK) Limited, Oxon, UK
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: body weight variation did not exceed ±20% of the mean body weight at the start of treatment
- Fasting period before study: not specified
- Housing: individually housed in suspended solid floor polypropylene cages furnished with softwood flake bedding.
- Diet (e.g. ad libitum): free access to food (2014C Teklad Global Rodent diet supplied by Envigo RMS (UK) Limited, Oxon, UK)
- Water (e.g. ad libitum): free access to mains drinking water
- Acclimation period: minimum of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25 ºC
- Humidity (%): 30 - 70 %
- Air changes (per hr): minimum of 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 : 12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back and flanks of each animal were clipped free of hair.
- % coverage: Approximately 10% of total body surface
- 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
- the treated skin and surrounding hair wiped with cotton wool moistened with dimethyl sulfoxide to remove any residual test item.
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount applied: 2000 mg/kg bw (no correction made for purity)
- Constant volume or concentration used: 1.049 g/mL - Duration of exposure:
- 24h
- Doses:
- Limit test - 1000 mg/kg bw
Main 2000 mg/kg bw - No. of animals per sex per dose:
- Limit test - 1
Main - 2 - Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations and mortality checks were conducted at approximately 0.5, 1, 2, 4, 6 hours and subsequently once daily for 14 days. Scoring and criteria were consistent with the Draize Draize. Individual bodyweight were recorded prior to application of the test item on Day -1 (before dosing) and on Days 0, 7 and 14.
- Necropsy of survivors performed: yes - Statistics:
- n/a
Results and discussion
- Preliminary study:
- No effect observed
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- There were no deaths
- Clinical signs:
- other: There were no signs of systemic toxicity.
- Gross pathology:
- No abnormalities were noted at necropsy.
Any other information on results incl. tables
Table 1. Dermal Reactions at Dose level 2000 mg/kg
Dose Level (mg/kg) |
Animal Number and Sex |
Observation |
Effects Noted After Initiation of Exposure |
|||||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
|||
2000 |
2-0 |
Erythema |
2 |
2 |
1 |
0 |
?e |
?e |
?e |
?e |
?e |
?e |
?e |
?e |
?e |
?e |
Edema |
1 |
1 |
1 |
1 |
?od |
?od |
?od |
?od |
?od |
?od |
?od |
?od |
?od |
?od |
||
Other |
BlHd |
BlHdTh |
BlThSp |
BlThSp |
Sp |
SpSk |
SpSkSw |
SpSkSw |
SpSkSw |
SpSkSw |
SpSk |
SpSk |
SpSk |
SpSkSg |
||
3-0 |
Erythema |
1 |
2 |
2 |
2 |
?e |
?e |
?e |
?e |
?e |
?e |
?e |
?e |
?e |
?e |
|
Edema |
1 |
1 |
1 |
1 |
?od |
?od |
?od |
?od |
?od |
?od |
?od |
?od |
?od |
?od |
||
Other |
ThLf |
ThBl |
LfBlTh |
LfBlTh |
SpSw |
SpSw |
SpSw |
SpSw |
SpSw |
SpSw |
SpSw |
SpSw |
SpSwSk |
SsSgSk |
||
3-1 |
Erythema |
1 |
2 |
2 |
2 |
?e |
?e |
?e |
?e |
?e |
?e |
?e |
?e |
?e |
?e |
|
Edema |
1 |
1 |
1 |
1 |
?od |
?od |
?od |
?od |
?od |
?od |
?od |
?od |
?od |
?od |
||
Other |
ThLf |
ThBlLf |
ThBlLf |
ThBlLf |
SpSwSk |
SpSwSk |
SpSkSb |
SdSb |
SdSb |
SdSb |
SdSb |
SbSpSk |
SbSpSkSg |
SkSpSg |
0 = No reactions Hd = Dermal hemorrhage
Th = Thickening of the skin ?e = Dermal reactions prevented the accurate evaluation of erythema
Lf = Loss of skin flexibility ?od = Dermal reactions prevented the accurate evaluation of edema
Bl = Blanching of the skin Ss = Small superficial scattered scabs
Sp = Hardened brown colored scab
Sw = Scab undulating
Sk = Scab cracking
Sg = Scab lifting to revel glossy skin
Sb = Scab lifting at edges to reveal dried blood
Sd = Scab lifting to at edges to reveal further deeper scabbing
Table 2. Individual Body Weight Changes at Dose level 2000 mg/kg
Dose Level (mg/kg) |
Animal Number and Sex |
Body Weight (g) at Day |
Body Weight Change (g) During Week |
|||
0 |
7 |
14 |
1 |
2 |
||
2000 |
2-0 Female |
222 |
219 |
231 |
-3 |
12 |
3-0 Female |
229 |
232 |
232 |
3 |
0 |
|
3-1 Female |
232 |
229 |
232 |
-3 |
3 |
Table 3. Individual Necropsy Finding at Dose level 2000 mg/kg
Dose Level |
Animal Number and Sex |
Time of Death |
Macroscopic Observations |
2000 |
2-0 Female |
Killed Day 14 |
No abnormalities detected |
3-0 Female |
Killed Day 14 |
No abnormalities detected |
|
3-1 Female |
Killed Day 14 |
No abnormalities detected |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study the dermal LD50 was established to exceed 2000 mg/kg bw in female Wistar (RccHan:WIST) strain rat. Applicant assessment indicates, under the conditions of this study, and according to the GHS criteria, the LD50 cut-off value was considered to be greater than 5000 mg/kg body weight.
- Executive summary:
A study was performed according to OECD TG 402; Acute Toxicity (Dermal) and in accordance with GLP to assess the acute dermal toxicity of the test substance in the Wistar (RccHan:WIST) strain rat. Initial test was conducted with semi-occlusive application of undiluted test item at 1000 mg/kg bw to the clipped skin of one animinal. this is then followed by application of a single dose of the test item at a dose level of 2000 mg/kg body weight for a duration of 24 hour under semi-occluded condition and sequent observation for 14 days.
There was no mortality during the study. There were no signs of system toxicity or abnormalities on necropsy. Two animals treated at a dose level of 2000 mg/kg showed body weight loss with the remaining animal showing an expected gain in body weight during the first week. Two animals treated at a dose level of 2000 mg/kg showed expected gains in body weight with the remaining animal showing no gain in body weight during the second week. The animal treated at a dose level of 1000 mg/kg showed an expected gain in body weight during the observation period.. Signs of dermal irritation noted included very slight to well defined erythema and very slight edema, scattered areas of blanching over the treatment site, scattered areas of dermal hemorrhage over the treatment site, thickening of the skin, hardened light brown colored scabs, scab cracking, scab undulating, scab lifting to reveal glossy skin, scab lifting edge to reveal dried blood, scab lifting at edges to reveal further deeper scabbing, small superficial scattered scabs, glossy skin, loss of skin flexibility and loss of skin elasticity. The dermal reactions prevented the accurate evaluation of erythema and edema at several time points.
Under the conditions of this study the dermal LD50 was established to exceed 2000 mg/kg bw in female Wistar (RccHan:WIST) strain rat. Applicant assessment indicates, under the conditions of this study, and according to the GHS criteria, the LD50 cut-off value was considered to be greater than 5000 mg/kg body weight.
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