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EC number: 824-772-0 | CAS number: 2060540-82-9
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28 March 2017 to 13 April 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- OECD Guidelines for Testing of Chemicals No. 423. Acute Oral Toxicity – Acute Toxic Class Method. Adopted: 17 December 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- Commission Regulation (EC) No 440/2008 of 30 May 2008, B.1.tris
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- EPA Health Effects Test Guidelines (OPPTS 870.1100), United States, EPA 712-C-02-190 (2002)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- semi-solid (amorphous): gel
- Details on test material:
- Name: Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with cyclohexylamine
Synonym: PROCHINOR B 657
Batch/Lot No.: EP7377
CAS No.: 2060540-82-9
Expiry date: 21 November 2019
Purity: 10%
Composition: 10% UVCB, 90% water
Density: 1.129 g/mL
Description: Liquid gel
Storage condition: Room Temperature (15-25oC), protected from humidity and light
Safety precautions: Routine safety precautions (lab coat, gloves, safety glasses, face mask) for unknown materials were applied to assure personnel health and safety.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Species and strain: Crl:WI Wistar rats
Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, D-97633 Sulzfeld, Germany
Hygienic level at arrival: SPF
Hygienic level during the study: Standard housing conditions
Number of animals: 6 animals, 3 animals / group
Sex: Female, nulliparous and non-pregnant
Age of animals at dosing: Young healthy adult rats, 9 weeks old
Body weight at treatment: 196 – 216 g
Acclimation period: at least 13 days
Husbandry
Animal health: Only healthy animals were used for the test. The health status was certified by the staff Veterinarian.
Number of animal room: 242/3
Housing: 3 animals / cage
Cage type: Type II polypropylene/polycarbonate
Bedding: LIGNOCEL 3/4-S certified wooden chips (produced by J. Rettenmaier & Söhne GmbH + CO. KG 73494, Holzmühle, Rosenberg, Germany) was available to animals during the study.
Nesting: ARBOCEL crinklets natural nest building material (produced by J. Rettenmaier & Söhne GmbH + CO. KG 73494, Holzmühle, Rosenberg, Germany) was available to animals during the study.
Lighting period: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 19.6 – 25.0°C
Relative humidity: 30 – 58%
Ventilation: 15 – 20 air exchanges/hour
Enrichment: Animals were housed by group to allow social interaction and with deep wood sawdust bedding to allow digging and other normal rodent activities.
Food and Water Supply
Animals received ssniff® SM R/M "Autoclavable complete diet for rats and mice – breeding and maintenance" produced by ssniff Spezialdiäten GmbH, D-59494 Soest, Germany (Batch no.: 484 14771, expiry date: 30 June 2017 and Batch no.: 285 17890, expiry date: 31 August 2017), ad libitum, except for the night before treatment. Tap water from the municipal supply, as for human consumption was available from a 500 ml bottle, ad libitum. The food is considered not to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study.
Water quality control analysis is performed once every three months and microbiological assessment is performed monthly.
Animal Identification
Animals were individually identified using numbers written on the tail with an indelible pen. The numbers were given on the basis of CiToxLAB Hungary Ltd.'s Master File, for each animal allocated to the treatment groups. The cages were identified by cards, with information about study code, sex, dose group, cage number and individual animal numbers.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Formulation
The test item was administered undiluted for dose level of 2000 mg active ingredient/kg bw at a constant concentration adjusting for the specific gravity of the test material. This method was chosen considering the highest permissible dose volume (20 ml/kg bw) by the guideline.
Justification of the dose:
The initial dose level was selected by the Study Director to be that which is most likely to produce mortality in some of the dosed animals. Based on the preliminary toxicological information by the Sponsor, limit dose of 2000 mg active ingredient/kg bw was selected as a starting dose.
Initially, 3 female animals were treated with Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with cyclohexylamine at dose level of 2000 mg active ingredient/kg bw. Only 1 out of 3 animals died in this group, therefore further 3 animals were treated at the dose level of 2000 mg active ingredient/kg bw. Since only one animal died in this second dose group, further testing was not required according to the test guidelines (OECD 423, Commission Regulation (EC) No 440/2008 of 30 May 2008, B.1.tris). - Doses:
- 2000 mg active ingredient/kg bw.
- No. of animals per sex per dose:
- 3 animals per group (6 in total)
- Control animals:
- no
- Details on study design:
- Procedure
A single oral gavage administration was followed by a 14-day observation period. On the night before treatment, the animals were fasted. The food but not water was withheld during an overnight period. Animals were weighed just before treatment. The test item was administered by oral gavage in the morning. The food was returned 3 hours after the treatment.
Single oral gavage was administered using a constant concentration at the tested dose level of 2000 mg active ingredient/kg bw. Dose volume was 17.7 ml/kg bw considering the 1.129 g/mL density and the correction factor 10.
OBSERVATIONS
Clinical Observations
Clinical observations were performed on all animals at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter or until death. Individual observations were performed on the skin, fur, eyes, mucous membranes, respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Body Weight Measurement
The body weight was recorded on Days -1, 0 (before treatment), 7 and 14 (before necropsy) or at death.
NECROPSY
Macroscopic examination was performed on all animals. The animals were sacrificed by exsanguination under pentobarbital anaesthesia (Release®; Lot No.: 106075, Expiry Date: 31 July 2018, Produced by: Wirtschaftsgenossenschaft deutscher Tierärzte eG; Siemensstr. 14, 30827 Garbsen, Germany). After examination of the external appearance, the cranial, thoracic and abdominal cavities were opened and the appearance of the tissues and organs were observed. All gross pathological changes were recorded for each animal on the post mortem record sheets and the animals were discarded. - Statistics:
- The method used was not intended to allow the calculation of a precise LD50 value.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- Two out of 6 animals were found dead during the study at dose level of 2000 mg active ingredient/kg bw (1 animal in Group 1 and another in Group 2, both on Day 1).
- Clinical signs:
- At the dose level of 2000 mg active ingredient/kg bw, the following symptoms were observed: hunched back (6/6 animals, Day 0-2), straub like tail position (6/6 animals, Day 0), piloerection (4/6 animals, Day 0-1), irritability (3/6 animals, Day 0-1), slight activity decrease (3/6 animals, Day 0-1) and reddish coloured discharge from nose (1/6 animals, Day 1).
From Day 3 all surviving animals were symptom-free. - Body weight:
- There were no effects on body weights or body weight gains that could be attributed to treatment with Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with cyclohexylamine.
- Gross pathology:
- Yellowish liquid observed in the digestive contents of the stomach and/or duodenum/jejunum was considered to be treatment-related.
Dry red material observed in the fur of periorbital area (bilateral) and diffuse dark/red discolorations all lobes of the collapsed lungs found at necropsy, were considered to be non-treatment-related. Discoloured lungs are frequently seen in found dead rats.
There was no evidence of the macroscopic observations in animals subjected to the necropsy on Day 14.
Any other information on results incl. tables
CLINICAL OBSERVATIONS
DOSE LEVEL: 2000 mg/kg bw, Treatment on Day 0 SEX: FEMALE
Cage No. |
Animal Number |
Observations |
Observation days |
Frequency |
||||||||||||
0 |
1 |
2 |
3 |
4 |
5 |
6 |
7-14 |
|||||||||
30’ |
1h |
2h |
3h |
4h |
6h |
|||||||||||
1 |
7335# |
Symptom Free |
+ |
+ |
+ |
+ |
- |
- |
|
|
|
|
|
|
|
4/6 |
Irritability |
- |
- |
- |
- |
+ |
+ |
|
|
|
|
|
|
|
2/6 |
||
Hunched back |
- |
- |
- |
- |
+ |
+ |
|
|
|
|
|
|
|
2/6 |
||
Piloerection |
- |
- |
- |
- |
- |
+ |
|
|
|
|
|
|
|
1/6 |
||
Straub like tail position |
- |
- |
- |
- |
+ |
+ |
|
|
|
|
|
|
|
2/6 |
||
Found dead |
- |
- |
- |
- |
- |
- |
+ |
|
|
|
|
|
|
- |
||
7336 |
Symptom Free |
+ |
+ |
+ |
+ |
- |
- |
- |
- |
+ |
+ |
+ |
+ |
+ |
16/20 |
|
Activity decreased |
- |
- |
- |
- |
- |
- |
1 |
- |
- |
- |
- |
- |
- |
1/20 |
||
Hunched back |
- |
- |
- |
- |
+ |
+ |
+ |
+ |
- |
- |
- |
- |
- |
4/20 |
||
Piloerection |
- |
- |
- |
- |
- |
- |
+ |
- |
- |
- |
- |
- |
- |
1/20 |
||
Discharge, coloured (reddish, nose) |
- |
- |
- |
- |
- |
- |
+ |
- |
- |
- |
- |
- |
- |
1/20 |
||
Straub like tail position |
- |
- |
- |
- |
+ |
+ |
- |
- |
- |
- |
- |
- |
- |
2/20 |
||
7337 |
Symptom Free |
+ |
+ |
+ |
+ |
- |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
17/20 |
|
Activity decreased |
- |
- |
- |
- |
- |
- |
1 |
- |
- |
- |
- |
- |
- |
1/20 |
||
Hunched back |
- |
- |
- |
- |
+ |
+ |
+ |
- |
- |
- |
- |
- |
- |
3/20 |
||
Piloerection |
- |
- |
- |
- |
- |
- |
+ |
- |
- |
- |
- |
- |
- |
1/20 |
||
Straub like tail position |
- |
- |
- |
- |
+ |
+ |
- |
- |
- |
- |
- |
- |
- |
2/20 |
||
2 |
7338 |
Symptom Free |
+ |
+ |
- |
- |
- |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
15/20 |
Irritability |
- |
- |
+ |
+ |
+ |
+ |
+ |
- |
- |
- |
- |
- |
- |
5/20 |
||
Hunched back |
- |
- |
+ |
+ |
+ |
+ |
+ |
- |
- |
- |
- |
- |
- |
5/20 |
||
Straub like tail position |
- |
- |
- |
+ |
+ |
+ |
- |
- |
- |
- |
- |
- |
- |
3/20 |
||
7303# |
Symptom Free |
+ |
- |
- |
- |
- |
- |
|
|
|
|
|
|
|
1/6 |
|
Activity decreased |
- |
- |
- |
- |
- |
1 |
|
|
|
|
|
|
|
1/6 |
||
Hunched back |
- |
- |
+ |
+ |
+ |
+ |
|
|
|
|
|
|
|
4/6 |
||
Piloerection |
- |
+ |
+ |
+ |
+ |
+ |
|
|
|
|
|
|
|
5/6 |
||
Straub like tail position |
- |
- |
- |
+ |
+ |
+ |
|
|
|
|
|
|
|
3/6 |
||
Found dead |
- |
- |
- |
- |
- |
- |
+ |
|
|
|
|
|
|
- |
||
7304 |
Symptom Free |
+ |
- |
- |
- |
- |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
14/20 |
|
Irritability |
- |
- |
+ |
+ |
+ |
+ |
- |
- |
- |
- |
- |
- |
- |
4/20 |
||
Hunched back |
- |
+ |
+ |
+ |
+ |
+ |
+ |
- |
- |
- |
- |
- |
- |
6/20 |
||
Straub like tail position |
- |
- |
- |
+ |
+ |
+ |
- |
- |
- |
- |
- |
- |
- |
3/20 |
Remarks: + = present - = absent
h = hour ‘ = minute
# = Found dead
Frequency of observations = number of occurrences of observation / total number of observations
Severities = 1 = slight/Small/Few; 2 = Moderate/Medium; 3 = Marked/Large/Many
BODY WEIGHT DATA
DOSE LEVEL: 2000 mg/kg bw, Treatment on Day 0 SEX: FEMALE
Cage No. |
Animal Number |
Body Weight (g) |
Day/Body Weight (g) Death |
Body Weight Gain (g) |
||||||
Days |
||||||||||
-1 |
0 |
7 |
14 |
-1-0 |
0-7 |
7-14 |
-1-14 |
|||
1 |
7335# |
226 |
211 |
- |
- |
1/205 |
-15 |
- |
- |
- |
7336 |
225 |
214 |
251 |
270 |
- |
-11 |
37 |
19 |
45 |
|
7337 |
225 |
211 |
224 |
242 |
- |
-14 |
13 |
18 |
17 |
|
2 |
7338 |
206 |
196 |
215 |
223 |
- |
-10 |
19 |
8 |
17 |
7303# |
215 |
206 |
- |
- |
1/204 |
-9 |
- |
- |
- |
|
7304 |
227 |
216 |
236 |
247 |
- |
-11 |
20 |
11 |
20 |
|
Mean: |
220.7 |
209.0 |
231.5 |
245.5 |
- |
-11.7 |
22.3 |
14.0 |
24.8 |
|
Standard deviation: |
8.4 |
7.2 |
15.6 |
19.3 |
- |
2.3 |
10.3 |
5.4 |
13.6 |
- = No data
# = Found dead
NECROPSY FINDINGS
DOSE LEVEL: 2000 mg/kg bw, Treatment on Day 0 SEX: FEMALE
Cage No. |
Animal Number |
Necropsy Date/ Necropsy Day |
External Observations |
Internal Observations |
Organ/Tissue |
1 |
7335# |
29 March 2017 Day 1 |
Fur: Material, dry, red, periorbital area, bilateral |
Collapsed |
Lungs |
Discoloration, dark red, diffuse, all lobes |
|||||
Digestive Content: Material, liquid, yellowish |
Stomach and Duodenum and Jejunum |
||||
7336 |
11 April 2017 Day 14 |
No external observations recorded |
No internal observation recorded |
Not applicable |
|
7337 |
11 April 2017 Day 14 |
No external observations recorded |
No internal observation recorded |
Not applicable |
|
2 |
7338 |
13 April 2017 Day 14 |
No external observations recorded |
No internal observation recorded |
Not applicable |
7303# |
31 March 2017 Day 1 |
No external observations recorded |
Collapsed |
Lungs |
|
Discolouration, dark red. Diffuse, all lobes |
|||||
Digestive Content: Material, liquid, yellowish |
Stomach |
||||
7304 |
13 April 2017 Day 14 |
No external observations recorded |
No internal observations recorded |
Not applicable |
# = Found dead
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- Under the conditions of this study, the acute oral LD50 value of the test item Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with cyclohexylamine was found to be above 2000 mg active ingredient/kg bw in female Crl:WI rats.
According the GHS criteria, Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with cyclohexylamine can be ranked as "Category 5" for acute oral exposure. - Executive summary:
The single-dose oral toxicity of Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with cyclohexylamine was performed according to the acute toxic class method (OECD 423 and Commission Regulation (EC) No 440/2008 of 30 May 2008, B.1.tris) in Crl:WI Wistar rats.
Two groups of 3 female Crl:WI rats were treated with the test item at a dose level of 2000 mg active ingredient/kg body weight (bw) (Group 1 and Group 2).
A single oral treatment was carried out by gavage for each animal after an overnight food withdrawal. Food was made available again 3 hours after the treatment. The test item was administered undiluted for dose level of 2000 mg active ingredient/kg bw at a constant concentration adjusting for the specific gravity of the test material.
Initially, three females (Group 1) were treated at a dose level of 2000 mg active ingredient/kg bw. Only 1 out of 3 animals died in this group, therefore further 3 animals (Group 2) were treated at the dose level of 2000 mg active ingredient/kg bw.
Since only one animal died in this second dose group, further testing was not required according to the test guidelines (OECD 423, Commission Regulation (EC) No 440/2008 of 30 May 2008, B.1.tris).
Clinical observations were performed at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter or until death. Body weight was measured on Days -1, 0, 7 and 14 (before necropsy) or at death. All animals were subjected to a necropsy and a macroscopic examination.
The results of the study were summarised as follows:
Mortality
Two out of 6 animals were found dead during the study at dose level of 2000 mg active ingredient/kg bw (1 animal in Group 1 and another in Group 2, both on Day 1).
Clinical Observations
At the dose level of 2000 mg active ingredient/kg bw, the following symptoms were observed: hunched back (6/6 animals, Day 0-2), straub like tail position (6/6 animals, Day 0), piloerection (4/6 animals, Day 0-1), irritability (3/6 animals, Day 0-1), slight activity decrease (3/6 animals, Day 0-1) and reddish coloured discharge from nose (1/6 animals, Day 1).
From Day 3 all surviving animals were symptom-free.
Body Weight and Body Weight Gain
There were no effects on body weights or body weight gains that could be attributed to treatment with Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. With cyclohexylamine.
Necropsy
Yellowish liquid observed in the digestive contents of the stomach and/or duodenum/jejunum was considered to be treatment-related.
Dry red material observed in the fur of periorbital area (bilateral) and diffuse dark/red discolorations all lobes of the collapsed lungs found at necropsy, were considered to be non-treatment-related. Discoloured lungs are frequently seen in found dead rats.
There was no evidence of the macroscopic observations in animals subjected to the necropsy on Day 14.
Conclusion:
Under the conditions of this study, the acute oral LD50 value of the test item Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with cyclohexylamine was found to be greater than 2000 mg active ingredient/kg bw in female Crl:WI rats.
According to the GHS criteria, Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with cyclohexylamine can be ranked as "Category 5" for acute oral exposure.
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