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EC number: 696-001-4 | CAS number: 944129-07-1
- 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:
- 25 April 2012 to 16 May 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
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:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 944127-07-1
- IUPAC Name:
- 944127-07-1
- Test material form:
- other: solid (unspecified)
- Details on test material:
- - Appearance: White Solid
- Storage conditions of the test material: Ambient (18 to 36 °C)
- pH of test material: 4.60
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 10 to 12 weeks
- Weight at study initiation: Males: 260.29 to 294.73 g; Females: 203.13 to 210.10 g. Weight variation did not exceed ± 20 % of the mean weight for each sex.
- Fasting period before study: No
- Housing: Rats were housed individually in standard polysulfone cages (Size: approximately 425 mm long x 266 mm deep x 175 mm high), with stainless steel top grills having facilities for pelleted food and drinking water. Steam sterilised clean corn cob bedding was used and changed along with the cage twice weekly. The rats were provided with huts as environmental enrichment in each cage during the experimental period.
- Diet (e.g. ad libitum): Standard rat and mouse pelleted maintenance diet was provided ad libitum
- Water (e.g. ad libitum): Deep bore-well water passed through activated charcoal filter and exposed to UV rays in a water filter-cum-purifier was provided to animals ad libitum in polycarbonate bottles with stainless steel sipper tubes. The water in the bottles was replenished once daily and the water bottles were changed once a week.
- Acclimation period: Five days for the females and seven days for the males under laboratory conditions.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 23 °C
- Humidity (%): 65 to 67 % (relative)
- Air changes (per hr): 12 to 15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours of light and 12 hours of dark
IN-LIFE DATES: From: 25 April 2012 To: 16 May 2012
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- The test material was made into a paste with Milli-Q water.
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Dorsolateral thoracic surface. Approximately 24 hours prior to treatment, the hair on the skin was clipped (approximately 8 x 10 cm) with an electric clipper.
- % coverage: About 10 % of the body surface of each animal.
- Type of wrap if used: The test material was applied on 6 ply cotton gauze patches (males: 9 x 6 cm; females: 8 x 5 cm). The patch was secured in position by non-allergenic surgical tape wound around the torso.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The tape and patches were removed and the application sites were wiped with water and clean towels to remove any residual test material.
- Time after start of exposure: After the 24 hour contact period.
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg body weight.
- For solids, paste formed: Yes, with Milli-Q water.
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 to 0.7 mL. - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 5 animals per sex per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following application: 14 days following test material application.
- Frequency of observations and weighing: The animals were observed five times on test day 1 (day of application), at 30 minutes, 1, 2, 3 and 4 hours after dose application and once daily during days 2 to 15. Individual body weights of animals were recorded on test day 1 (pre-application), day 8 (7 days post application) and day 15 (14 days post application). The site of application was observed for local skin reactions once daily during the 14 day observation period.
- Necropsy of survivors performed: Yes. All animals were necropsied at the end of the 14 day observation period; animals were sacrificed by exsanguination under isoflurane anaesthesia. External surfaces of the body, all orifices, tissues and organs of the thoracic and abdominal cavities of all animals were examined. All necropsy observations were recorded.
Results and discussion
- Preliminary study:
- The limit test at 2000 mg/kg was initiated with five female rats. As there was no test material-related mortality, five male rats were tested at the same dose.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There was no mortality. All animals exposed to the limit dose survived.
- Clinical signs:
- other: There were no clinical signs of toxicity in any animal.
- Gross pathology:
- There were no abnormalities detected at necropsy.
- Other findings:
- There were no skin reactions observed at the site of application.
Any other information on results incl. tables
Table 1: Body Weight and Body Weight Changes
Sex |
Rat Number |
Body weight (g) |
||||
Initial |
Day 8 |
Weight change (Day 8 - Initial) |
Day 15 |
Weight change (Day 15 - Initial) |
||
F |
Rm851 |
203.13 |
209.32 |
6.19 |
217.38 |
14.25 |
Rm852 |
205.03 |
209.19 |
4.16 |
215.10 |
10.07 |
|
Rm853 |
210.10 |
217.11 |
7.01 |
227.35 |
17.25 |
|
Rm854 |
207.86 |
216.19 |
8.33 |
221.15 |
13.29 |
|
Rm855 |
203.18 |
213.28 |
10.10 |
222.71 |
19.53 |
|
M |
Rm856 |
291.41 |
310.86 |
19.45 |
335.79 |
44.38 |
Rm857 |
277.34 |
290.75 |
13.41 |
312.01 |
34.67 |
|
Rm858 |
265.63 |
277.19 |
11.56 |
289.48 |
23.85 |
|
Rm859 |
260.29 |
276.13 |
15.84 |
289.92 |
29.63 |
|
Rm860 |
294.73 |
317.33 |
22.60 |
338.14 |
43.41 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the acute dermal LD50 was >2000 mg/kg bodyweight in male and female Wistar strain rats and the test material requires no classification in accordance with EU criteria.
- Executive summary:
The acute dermal toxicity potential of the test material to male and female Wistar strain rats was assessed in accordance with the standardised guidelines OECD 402 and US EPA OPPTS 870.1200 under GLP conditions.
The study was initiated with a limit test at 2000 mg/kg in five female rats. The test material was made into a paste with Milli-Q water and administered as a single dermal dose to the clipped dorsolateral thoracic surface. As no mortality, local skin reactions or clinical signs were observed, the test material was similarly administered to five male rats.
Rats were observed for 14 days post treatment. All animals were sacrificed as scheduled on study Day 15 and subjected to gross necropsy.
There were no clinical signs of toxicity and none of the animals died. No local skin reactions were observed and all the animals gained body weight during the 14-day observation period. There were no gross abnormalities detected in any of the rats at necropsy.
Under the conditions of this study, the acute dermal LD50 was determined to be >2000 mg/kg bodyweight in male and female Wistar strain rats, indicating the test material requires no classification in accordance with EU criteria.
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