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EC number: 834-894-6 | CAS number: 113601-85-7
- 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
Endpoint summary
Administrative data
Description of key information
Acute Oral:
The acute oral LD50 value of the test item SN-475N was found to be above 2000 mg/kg bw in female CRL:(WI) rats.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 September 2012 to 31 October 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Specific details on test material used for the study:
- No further details specified in the study report
- Species:
- rat
- Strain:
- other: CRL:(WI) rats
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Species and strain: CRL:(WI) rats
Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, D-97633 Sulzfeld
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, 10 -11 weeks old
Body weight at treatment: 214 -238 g
Acclimation period: At least 19 days
Husbandry
Animal health: Only healthy animals were used for the test. The veterinarian certified health status.
Number of animal room: 522/9
Housing: 3 animals / cage
Cage type: Type II polypropylene/polycarbonate
Bedding: Lignocel Bedding for Laboratory Animals was available to animals during the study.
A copy of the Certificate of Analysis is retained in the archive at CiToxLAB Hungary Ltd.
Lighting period: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 22 ± 3 °C
Relative humidity: 30 - 70 %
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.
The temperature and relative humidity were recorded twice daily during the study.
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 ad libitum, and tap water from the municipal supply, as for human consumption from 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.
For contents of the diet see Appendix 5. The supplier provided an analytical certificate for the batch used.
Water quality control analysis is performed once every three months and microbiological assessment is performed monthly, by Veszprém County Institute of State Public Health and Medical Officer Service (ÁNTSZ, H-8201 Veszprém, József A.u.36., Hungary). The quality control results are retained in the archives at CiToxLAB Hungary Ltd.
Animal Identification
Animals were individually identified using numbers written on the tail with an indelible marker 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 number. - Route of administration:
- oral: gavage
- Vehicle:
- DMSO
- Details on oral exposure:
- A single oral gavage administration was followed by a fourteen-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.
- Doses:
- 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. In the lack of any preliminary toxicological information, 2000 mg/kg bw was selected to be the starting dose.
Initially, three females (Group 1) were treated at a dose level of 2000 mg/kg bw. As no mortality was observed, a confirmatory group (Group 2) was treated at the same dose level. No mortality was observed in the confirmatory group, therefore no further testing was required according to OECD 423 and Commission Regulation (EC) NO 440/2008 of 30 May 2008, B.1.Tris. - No. of animals per sex per dose:
- 6 animals. 3 animals/group
- Control animals:
- no
- Details on study design:
- Procedure
A single oral gavage administration was followed by a fourteen-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.
OBSERVATIONS
Clinical Observations
Clinical observations were performed at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter. 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 the day before treatment (Day -1), on the day of the treatment (Day 0), on Day 7 and before necropsy.
NECROPSY
Macroscopic examination was performed on all animals. The surviving animals were sacrificed by exsanguination under pentobarbital anaesthesia (Euthasol® 40 %; Lot: 11H15 8; Expiry date: July 2014; Produced by: Produlab Pharma, Raamsdonksveer). After examination of the external appearance, the cranial, thoracic and the abdominal cavities were opened and the organs and the tissues were observed. Macroscopic abnormalities were recorded. - Statistics:
- Not specified
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- SN-475N did not cause mortality at a dose level of 2000 mg/kg bw.
- Clinical signs:
- other: No clinical signs were observed after the treatment with the test item or during the 14 day observation period.
- Gross pathology:
- No macroscopic observations were present at a dose level of 2000 mg/kg bw.
- Other findings:
- Not specified
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Under the conditions of this study, the acute oral LD50 value of the test item SN-475N was found to be above 2000 mg/kg bw in female CRL:(WI) rats.
- Executive summary:
The single-dose oral toxicity of SN-475N was performed according to the acute toxic class method (OECD No. 423 and Commission Regulation (EC) NO 440/2008 of 30 May 2008, B.1.Tris) in CRL:(WI) rats.
Two groups of three female CRL:(WI) rats were treated with the test item at a dose level of 2000 mg/kg bw (Group 1 and Group 2).
Initially, three females (Group 1) were treated at a dose level of 2000 mg/kg bw. As no mortality was observed, a confirmatory group (Group 2) was treated at the same dose level. No mortality was observed in the confirmatory group, therefore no further testing was required according to OECD 423 and Commission Regulation (EC) NO 440/2008 of 30 May 2008, B.1.Tris.
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 formulated in Dimethyl sulfoxide at a concentration of 200 mg/mL at a dosing volume of 10 mL/kg bw.
Clinical observations were performed at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter. Body weight was measured on Days -1, 0 and 7 and before necropsy. All animals were subjected to a necropsy and a macroscopic examination.
Results
Mortality
SN-475N did not cause mortality at a dose level of 2000 mg/kg bw.
Clinical observations
No clinical signs were observed after the treatment with the test item or during the 14 day observation period.
Body weight and body weight gain
Body weight gains of SN-475N treated animals during the study showed no indication of a test item-related effect.
Macroscopic Findings
No macroscopic observations were present at a dose level of 2000 mg/kg bw.
Conclusion:
Under the conditions of this study, the acute oral LD50 value of the test item SN-475N was found to be above 2000 mg/kg bw in female CRL:(WI) rats.
According to the GHS criteria, SN-475N can be ranked as "Unclassified" for acute oral exposure.
Reference
The method used was not intended to allow the calculation of a precise LD50 value.
The test item was ranked into categories of Globally Harmonized System (GHS) described in the OECD Guideline No. 423.
Clinical signs, body weight, body weight gain and gross macroscopic data were tabulated.
CLINICAL OBSERVATIONS
DOSE LEVEL: 2000 mg/kg bw, Treatment on Day 0SEX: FEMALE30
Cage No. |
Animal Number |
Observations |
Observation days |
Frequency |
||||||
0 |
1-14 |
|||||||||
30’ |
1h |
2h |
3h |
4h |
6h |
|||||
1 |
6639 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
20/20 |
6640 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
20/20 |
|
6641 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
20/20 |
|
2 |
6642 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
20/20 |
6643 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
20/20 |
|
6644 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
20/20 |
Remarks: + = present , h = hour (s), ‘ = minute,
Frequency of observations = number of occurrence of observation / total number of observations
BODY WEIGHT DATA
DOSE LEVEL: 2000 mg/kg bw, Treatment on Day 0SEX: FEMALE
Cage No. |
Animal Number |
Body weight (g) Days |
Body weight Gain (g) |
||||||
-1 |
0 |
7 |
14 |
-1 - 0 |
0 - 7 |
7 -14 |
-1 - 14 |
||
1 |
6639 |
250 |
230 |
262 |
279 |
-20 |
32 |
17 |
29 |
6640 |
256 |
238 |
266 |
269 |
-18 |
28 |
3 |
13 |
|
6641 |
243 |
224 |
257 |
272 |
-19 |
33 |
15 |
29 |
|
2 |
6642 |
237 |
224 |
255 |
274 |
-13 |
31 |
19 |
37 |
6643 |
234 |
214 |
249 |
253 |
-20 |
35 |
4 |
19 |
|
6644 |
236 |
219 |
262 |
272 |
-17 |
43 |
10 |
36 |
|
Mean |
242.7 |
224.8 |
258.5 |
269.8 |
-17.8 |
33.7 |
11.3 |
27.2 |
|
Standard deviation: |
8.8 |
8.4 |
6.1 |
8.9 |
2.6 |
5.1 |
6.8 |
9.5 |
NECROPSY FINDINGS
DOSE LEVEL: 2000 mg/kg bw, Treatment on Day 0SEX: FEMALE
Cage No. |
Animal Number |
Necropsy Day |
External Observations |
Internal Observations |
Organ / Tissue |
1 |
6639 |
Day 14 |
No external observations recorded |
No internal observations recorded |
Not applicable |
6640 |
Day 14 |
No external observations recorded |
No internal observations recorded |
Not applicable |
|
6641 |
Day 14 |
No external observations recorded |
No internal observations recorded |
Not applicable |
|
2 |
6642 |
Day 14 |
No external observations recorded |
No internal observations recorded |
Not applicable |
6643 |
Day 14 |
No external observations recorded |
No internal observations recorded |
Not applicable |
|
6644 |
Day 14 |
No external observations recorded |
No internal observations recorded |
Not applicable |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
According to the GHS criteria, SN-475N can be ranked as "Unclassified" for acute oral exposure.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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