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EC number: 245-524-2 | CAS number: 23251-72-1
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 1999-07-29 to 1999-08-19
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study is the result of a structural analogue substance used as read-across substance. Study is conducted according to Guidelines in a GLP certified laboratory.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
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:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- RA1
- IUPAC Name:
- RA1
- Test material form:
- other: liquid
- Details on test material:
- - Physical state: Pale yellow liquid
- Stability under test conditions: Stable under storage conditions
- Storage condition of test material: At room temperature (17-23°C)away from direct sunlight.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd.,
Biotechnology & Animal Breeding Division,
CH-4414 Füllinsdorf,
Switzerland.
- Age at study initiation: Males: 9 weeks
Females: 12 weeks
- Housing: During Acclimatization: In groups of five in Makrolon type-4 cages with standard softwood bedding.
During treatment and observation: Individually in Makrolon type-3 cages with standard softwood bedding.
- Diet (e.g. ad libitum): Pelleted standarad Kliba 3433, batch no. 37/99, rat maintenance diet.
- Water (e.g. ad libitum): Community tap water from Itingen.
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3°C
- Humidity (%): 40-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light.
IN-LIFE DATES: From: August 5th 1999 To: August 19th 1999.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Backs of the animals.
- % coverage: 10%
- Type of wrap if used: Semi-occlusive dressing.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lukewarm tap water amd dried with disposable paper towels.
- Time after start of exposure: Twenty-four hours after the application.
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.0 ml.
- Constant volume or concentration used: yes - Duration of exposure:
- 24 hours of exposure with an observation period of 14 days.
- Doses:
- 2000 mg/kg body weight.
- No. of animals per sex per dose:
- 5 males
5 females - Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality/viability four times during test day 1 and once daily during days 2 - 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs: Examined for changes in appearance and behaviour four times during day 1 and once daily during days 2 - 15.
- Body weight: On test day 1 (pre-administration), 8 and 15.
Necropsies were performed by experienced prosectors. At the end of the observation period all animals were sacrificed by intreperitoneal injection of NARCOREN at a dose of at least 2.0 ml/kg bw (equivalent to at least 320 mg sodium pentobarbitone/kg body weight). The animals were examined macroscopically and all abnormalities recorded. Thereafter, they were discarded. - Statistics:
- No statistical analysis was used as no deaths occurred.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality
- Mortality:
- No deaths occurred during the study.
- Clinical signs:
- other: No systemic or local signs of toxicity were observed during the study period.
- Gross pathology:
- No macroscopic findings were observed at necropsy.
Any other information on results incl. tables
Table 1: Clinical/Local Signs
Sex |
Animal No. |
Signs |
Test Day |
|||||||||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
||||||
1h |
2h |
3h |
4h |
|||||||||||||||||
Female 2000 mg/kg |
1 |
No clinical signs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2 |
No clinical signs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3 |
No clinical signs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Male 2000 mg/kg |
1 |
No clinical signs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2 |
No clinical signs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3 |
No clinical signs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Table 2: Body Weights
Body Weights |
||||
Sex |
Animal No. |
Day of Treatment |
Day 8 |
Day 15 |
Male 2000 mg/kg |
1 2 3 4 5 |
254.6 247.3 262.9 242.8 223.5 |
296.3 284.3 301.9 268.5 249.2 |
334.8 322.1 345.7 285.8 270.2 |
Female 2000 mg/kg |
6 7 8 9 10 |
200.3 202.3 210.3 209.8 205.0 |
200.4 202.3 208.1 215.5 212.8 |
205.9 216.1 213.6 226.0 221.5 |
Table 3: Macroscopic Findings
Sex |
Animal No. |
Type of death |
Findings |
Female 2000 mg/kg |
1 |
Scheduled necropsy |
No macroscopic findings |
2 |
Scheduled necropsy |
No macroscopic findings |
|
3 |
Scheduled necropsy |
No macroscopic findings |
|
4 |
Scheduled necropsy |
No macroscopic findings |
|
5 |
Scheduled necropsy |
No macroscopic findings |
|
Male 2000 mg/kg |
1 |
Scheduled necropsy |
No macroscopic findings |
2 |
Scheduled necropsy |
No macroscopic findings |
|
3 |
Scheduled necropsy |
No macroscopic findings |
|
4 |
Scheduled necropsy |
No macroscopic findings |
|
5 |
Scheduled necropsy |
No macroscopic findings |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The median lethal dose of RA1 after single dermal administration to rats of both sexes, observed over a period of 14 days, could not be estimated as no death occurred. The 24-hr LD50 is greater than 2000 mg/kg bw.
- Executive summary:
RA1 was evaluated for its potential to induce acute toxicity following dermal administration at a dose of 2000 mg/kg bw in male and female Wistar rats.
Animals were treated with RA1 at 2000 mg/kg bw by dermal application for 24 hr. The test article was administered undiluted at a volume of 2 ml/kg. The animals were examined for clinical signs and mortality/viability for 14 days after application of the test substance.
No deaths occurred during the study and no clinical signs were observed. In addition, the body weight of the animals was unaffected by treatment and no macroscopic findings were observed at necropsy.
Based on these results, the 24-hr median lethal dose of RA1 after single dermal administration to rats of both sexes is greater than 2000 mg/kg bw.
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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