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EC number: 835-272-7 | CAS number: 256374-76-2
- 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:
- 19 March 2015 to 02 April 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- OECD Guidelines for Testing of Chemicals, Section 4, Number 402 "Acute Dermal Toxicity", adopted February 24, 1987.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- Commission Regulation (EC) No 440/2008, B.3 (L 142, 30 May 2008)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 2-({2-[(5,5-dimethyl-2-oxo-1,3,2λ⁵-dioxaphosphinan-2-yl)amino]ethyl}amino)-5,5-dimethyl-1,3,2λ⁵-dioxaphosphinan-2-one
- EC Number:
- 835-272-7
- Cas Number:
- 256374-76-2
- Molecular formula:
- C12H26N2O6P2
- IUPAC Name:
- 2-({2-[(5,5-dimethyl-2-oxo-1,3,2λ⁵-dioxaphosphinan-2-yl)amino]ethyl}amino)-5,5-dimethyl-1,3,2λ⁵-dioxaphosphinan-2-one
- Test material form:
- solid: particulate/powder
- Details on test material:
- Name
Name: Reaction products of ethane-1,2-diamine, phosphoryl=trichloride and 2,2-dimethylpropane-1,3-diol which makes N,N'-bis(5,5-dimethyl-1,3,2-dioxaphosphinane=2-oxide-2-yl)ethane-1,2-diamine as a main component
Other name: SH-0850
CAS number: 256374-76-2 (main component)
Structural formula
Molecular formula: C12H26N2O6P2 (main component)
Molecular weight: 356.29 (main component)
Provided sample
Purity of the test substance: 100%
Lot number: SK-241002
Physical-chemical properties
Solubility in water: Less than 0.03% (w/w) by visual observation
Melting point: 277 °C
Appearance at normal temperatures: White powder
Storage condition
The test substance was stored in a dark place at room temperature.
Precaution for handling
Protective gloves, mask, glasses and clothes were put on in order to avoid contacts with skin or eyes and inhalation.
Constituent 1
- Specific details on test material used for the study:
- No further details specified in the study report.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Animals
Species and strain: Crl:WI 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
Justification of strain: Recognized by international guidelines as a recommended test system
Number of animals: 5 animals / sex
Sex: Male and female, female rats were nulliparous and non-pregnant.
Age of animals at dosing: Young adult rats
Body weight range at dosing: Males: 242-262 g; Females: 216-237 g
Age at dosing: Males: 7 weeks; Females: 8-9 weeks
Acclimatization time: 7 days
Husbandry
Animal health: Only healthy animals were used for the study. The veterinarian certified the health status.
Room: 242/6
Housing: Individual caging
Cage type: Type II. polypropylene/polycarbonate
Bedding: “Grade 5” Bedding for Laboratory Animals was available to animals during the study. A copy of the Certificate of Analysis is retained in the archives at CiToxLAB Hungary Ltd.
Light: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 21.0 – 23.4 °C
Relative humidity: 31 – 51 %
Ventilation: 15-20 air exchanges per hour
Enrichment: Rodents are housed 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 (Batch no.: 680 2237, Expiry date: March 2015 or Batch no.: 814 3108, Expiry date: August 2015), ad libitum, and tap water from municipal supply, as for human consumption from 500 ml bottles, ad libitum. The food was 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, 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.
Identification
Animals were identified by numbers written on the tail with an indelible marker. The numbers were given on the basis of the CiToxLAB Hungary Ltd. master file, for each animal allocated to the study.
The boxes were identified by cards holding information on the study code, the sex of animals, the dose group, the cage number and the individual animal number.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- The test item was administered in a single dose as supplied by the Sponsor, but sufficient water was used to moisten the test material to ensure good contact with the skin.
A single administration was performed by the dermal route and was followed by a fourteen-day observation period. The test item was applied as supplied.
The back of the animals were shorn (approximately 10% area of the total body surface) approximately 24 hours prior to the treatment. Only the animals without injury or irritation on the skin were used in the test.
On the test day (Day 0), the test item was applied as a single dose of 2000 mg/kg bw after the moistening with sufficient water, applied uniformly over the skin by use of a gauze pad (ca. 5 cm x 5 cm), and remained on the skin throughout a 24-hour exposure period. Sterile gauze pads were placed on the skin of rats at the site of application. These gauze pads were kept in contact with the skin by a patch with adhesive hypoallergenic plaster. The entire trunk of the animal was then wrapped with semi occlusive plastic wrap for 24 hours. At the end of the exposure period, residual test item was removed, using body temperature water. - Duration of exposure:
- 24-hour exposure period.
- Doses:
- A limit dose of 2000 mg/kg bw was chosen by the Study Director in agreement with the Sponsor.
- No. of animals per sex per dose:
- 10 animals (5 males/5 females)/
- Control animals:
- no
- Details on study design:
- Clinical observations
A clinical examination was performed on the day of treatment, at 1 and 5 hours after the application of the test item, and once each day for 14 days thereafter.
Observations included the skin and fur, eyes and mucous membranes, and also respiratory, circulatory, autonomic and central nervous system, and somatomotor activity and behaviour pattern. Particular attention was directed to the observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Skin Irritation
Adverse skin reactions at the site of application were recorded daily following the removal of the dressing (for scoring scheme see "Any other information" for details).
Measurement of body weight
The body weight of all animals was recorded on Day 0 (beginning of the experiment) and on Days 7 and 14.
Post Mortem Investigations
All animals were subjected to gross macroscopic examination. All animals were anaesthetised with an injection of pentobarbital solution and exsanguinated. After examination of the external appearance, the cranial, thoracic and abdominal cavities were opened and the appearance of the tissues and organs were observed. Any gross macroscopic findings were recorded. - Statistics:
- Not specified
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred after the 24-hour dermal exposure to SH-0850 in Crl:WI rats.
- Clinical signs:
- other: Systemic Clinical Signs: Each rat was symptom-free during the entire study. Local Dermal Signs: No local dermal signs were recorded after treatment with the test item during the 14 days observation period.
- Gross pathology:
- No external or internal macroscopic findings were observed at a dose level of 2000 mg/kg bw at necropsy.
Any other information on results incl. tables
Clinical Observations
DOSE LEVEL: 2000 mg/kg bw SEX: MALE
Cage No. |
Animal No. |
Observations |
Observations days |
Frequency |
|||||||||||||||
0 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
|||||
1h |
5h |
||||||||||||||||||
1 |
2456 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/16 |
2 |
2457 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/16 |
3 |
2458 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/16 |
4 |
2459 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/16 |
5 |
2460 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/16 |
DOSE LEVEL: 2000 mg/kg bw SEX: FEMALE
Cage No. |
Animal No. |
Observations |
Observations days |
Frequency |
|||||||||||||||
0 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
|||||
1h |
5h |
||||||||||||||||||
6 |
2461 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/16 |
7 |
2462 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/16 |
8 |
2463 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/16 |
9 |
2464 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/16 |
10 |
2465 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/16 |
Remarks: + = present
h = hour(s) Treatment day = Day 0
Frequency of observation = number of occurrence of observation / total number of observations
Body Weight and Body Weight Gain
DOSE LEVEL: 2000 mg/kg bw SEX: MALE
Cage No. |
Animal No. |
Boy weight (g) Days |
Body Weight Gain (g) |
||||
0 |
7 |
14 |
0-7 |
7-14 |
0-14 |
||
1 |
2456 |
242 |
285 |
325 |
43 |
40 |
83 |
2 |
2457 |
259 |
297 |
352 |
38 |
55 |
93 |
3 |
2458 |
252 |
291 |
336 |
39 |
45 |
84 |
4 |
2459 |
245 |
289 |
335 |
44 |
46 |
90 |
5 |
2460 |
262 |
332 |
398 |
70 |
66 |
136 |
Mean: |
252.0 |
298.8 |
349.2 |
46.8 |
50.4 |
97.2 |
|
Standard deviation: |
8.6 |
19.1 |
28.9 |
13.2 |
10.3 |
22.1 |
DOSE LEVEL: 2000 mg/kg bw SEX: FEMALE
Cage No. |
Animal No. |
Boy weight (g) Days |
Body Weight Gain (g) |
||||
0 |
7 |
14 |
0-7 |
7-14 |
0-14 |
||
6 |
2461 |
225 |
241 |
264 |
16 |
23 |
39 |
7 |
2462 |
237 |
229 |
238 |
-8 |
9 |
1 |
8 |
2463 |
226 |
231 |
237 |
5 |
6 |
11 |
9 |
2464 |
234 |
252 |
256 |
18 |
4 |
22 |
10 |
2465 |
216 |
234 |
239 |
18 |
5 |
23 |
Mean: |
227.6 |
237.4 |
246.8 |
9.8 |
9.4 |
19.2 |
|
Standard deviation: |
8.3 |
9.3 |
12.4 |
11.3 |
7.8 |
14.3 |
Necropsy Findings
DOSE LEVEL: 2000 mg/kg bw SEX: MALE
Cage No. |
Animal No. |
Necropsy Date/ Study Day |
External Observations |
Internal Observations |
Organ/Tissue |
1 |
2456 |
02 April 2015 Day 14 |
No external observations |
No internal observations |
Not applicable |
2 |
2457 |
02 April 2015 Day 14 |
No external observations |
No internal observations |
Not applicable |
3 |
2458 |
02 April 2015 Day 14 |
No external observations |
No internal observations |
Not applicable |
4 |
2459 |
02 April 2015 Day 14 |
No external observations |
No internal observations |
Not applicable |
5 |
2460 |
02 April 2015 Day 14 |
No external observations |
No internal observations |
Not applicable |
DOSE LEVEL: 2000 mg/kg bw SEX: FEMALE
Cage No. |
Animal No. |
Necropsy Date/ Study Day |
External Observations |
Internal Observations |
Organ/Tissue |
6 |
2461 |
02 April 2015 Day 14 |
No external observations |
No internal observations |
Not applicable |
7 |
2462 |
02 April 2015 Day 14 |
No external observations |
No internal observations |
Not applicable |
8 |
2463 |
02 April 2015 Day 14 |
No external observations |
No internal observations |
Not applicable |
9 |
2464 |
02 April 2015 Day 14 |
No external observations |
No internal observations |
Not applicable |
10 |
2465 |
02 April 2015 Day 14 |
No external observations |
No internal observations |
Not applicable |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The median lethal dose (LD50) of SH-0850 after a single dermal administration was found to be greater than 2000 mg/kg bw in male and female Crl:WI rats.
- Executive summary:
The purpose of the study was to assess the acute dermal toxicity of SH-0850 when administered to rats by a single semi-occlusive dermal application, followed by an observation period of 14 days. The test item was applied dermally to ten (5 males and 5 females) Crl:WI rats as supplied by the Sponsor. A limit test was carried out at 2000 mg/kg body weight (bw) in both sexes.
Clinical observations were performed on all animals at 1 and 5 hours after dosing and daily for 14 days thereafter. Body weight was measured prior to dosing on Day 0 and on Days 7 and 14. Rats were euthanized and subjected to a gross macroscopic examination at the end of the 2-week observation period (Day 14).
Results
Mortality
No mortality occurred after the 24-hour dermal exposure to SH-0850 in Crl:WI rats.
Systemic clinical signs
Each rat was symptom-free during the entire study.
Local dermal signs
No local dermal signs were recorded after treatment with the test item during the 14 days observation period.
Body weight
Slight body weight loss was observed in a single female animal between Day 0 and Day 7, but it was considered to be incidental and to have no toxicological relevance.
Necropsy
No external or internal macroscopic findings were noted at a dose level of 2000 mg/kg bw at necropsy.
Conclusion
The median lethal dose (LD50) of SH-0850 after a single dermal administration was found to be greater than 2000 mg/kg bw in male and female Crl:WI rats.
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