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EC number: 471-920-1 | CAS number: -
- 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:
- 15 November 2005 - 29 November 2005.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Protocol that complies with scientifically accepted methods, and is sufficiently detailed.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Details on test material:
- - Physical state: dark amber slightly viscous liquid
- Analytical purity: No data
- Stability under test conditions: undetermined
- Storage condition of test material: room temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Age at study initiation: 8-12 weeks old
- Weight at study initiation: at least 200 g
- Fasting period before study: none
- Housing: animals were housed in suspended solid-floor polypropylene cages furnished with woodflakes. The animals were housed individually during the 24-hour exposure period and in groups of five, by sex, for the remainder of the study
- Diet: Certified Rat and Mouse Diet (Code 5LF2) supplied by BCM IPS Limited, London, UK was provided ad libitum
- Water: tap water was available ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): at least 15/hour
- Photoperiod (hrs dark / hrs light): 12 h light/dark cycle.
IN-LIFE DATES: From: To: 15/11/2005 - 29/11/2005
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back and flanks
- % coverage: approximately 10 % of total body surface area
- Type of wrap if used: surgical gauze covered with self-adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with cotton wool moistened with distilled water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.27 mL/kg bw
- Concentration (if solution): the test material was used undiluted as supplied
- Constant volume or concentration used: yes
- For solids, paste formed: Not applicable
VEHICLE
- Amount(s) applied (volume or weight with unit): Not apllicable
- Concentration (if solution): Not applicable
- Lot/batch no. (if required): Not applicable
- Purity: Not applicable - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals/sex/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for deaths or overt signs of toxicity 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days. Individual bodyweights were recorded prior to application of the test material on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: gross necropsies were performed on all animals after sacrifice at the conclusion of the 14 day observation period. - Statistics:
- No data available
Results and discussion
- Preliminary study:
- Not applicable
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Male: Number of animals: 5; Number of deaths: 0
Female: Number of animals: 5; Number of deaths: 0 - Clinical signs:
- other: There were no signs of systemic toxicity.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- - Other observations: Individual dermal reactions are given in Table 2 below. Very slight erythema was noted at all treatment sites one and two days after dosing. Crust formation was noted at the treatment sites of three males and three females three to five days after treatment. Treatment sites appeared normal three or six days after treatment.
Any other information on results incl. tables
Table 1: Individual bodyweights and weekly bodyweight changes
Dose level (mg/kg) |
Animal No. & sex |
Bodyweight (g) at Day |
Bodyweight gain (g) during Week |
|||
0 |
7 |
14 |
1 |
2 |
||
2000 |
1-0 male |
299 |
348 |
399 |
49 |
51 |
1-1 male |
299 |
344 |
386 |
45 |
42 |
|
1-2 male |
297 |
346 |
383 |
49 |
37 |
|
1-3 male |
296 |
323 |
354 |
27 |
31 |
|
1-4 male |
300 |
346 |
383 |
46 |
37 |
|
2-0 female |
222 |
236 |
240 |
14 |
4 |
|
2-1 female |
232 |
240 |
249 |
8 |
9 |
|
2-2 female |
242 |
257 |
271 |
15 |
14 |
|
2-3 female |
242 |
245 |
266 |
3 |
21 |
|
2-4 female |
207 |
213 |
222 |
6 |
9 |
Table 2: Individual dermal reactions
Dose level (mg/kg) |
Animal No. & sex |
Observation |
Effects noted after initiation of exposure (Days) |
|||||
1 |
2 |
3 |
4 |
5 |
6-14 |
|||
2000 |
1-0 male |
Erythema Oedema Other |
1 0 0 |
1 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
1-1 male |
Erythema Oedema Other |
1 0 0 |
1 0 0 |
0 0 Cf |
0 0 Cf |
0 0 Cf |
0 0 0 |
|
1-2 male |
Erythema Oedema Other |
1 0 0 |
1 0 0 |
0 0 Cf |
0 0 Cf |
0 0 Cf |
0 0 0 |
|
1-3 male |
Erythema Oedema Other |
1 0 0 |
1 0 0 |
0 0 Cf |
0 0 Cf |
0 0 Cf |
0 0 0 |
|
1-4 male |
Erythema Oedema Other |
1 0 0 |
1 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
|
2-0 female |
Erythema Oedema Other |
1 0 0 |
1 0 0 |
0 0 Cf |
0 0 Cf |
0 0 Cf |
0 0 0 |
|
2-1 female |
Erythema Oedema Other |
1 0 0 |
1 0 0 |
0 0 Cf |
0 0 Cf |
0 0 Cf |
0 0 0 |
|
2-2 female |
Erythema Oedema Other |
1 0 0 |
1 0 0 |
0 0 Cf |
0 0 Cf |
0 0 Cf |
0 0 0 |
|
2-3 female |
Erythema Oedema Other |
1 0 0 |
1 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
|
2-4 female |
Erythema Oedema Other |
1 0 0 |
1 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 = no reactions; Cf = crust formation
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test article, when administered as received to male and female Sprague-Dawley rats, had an acute dermal LD50 of greater than 2000 mg/kg bodyweight
- Executive summary:
Test Guidance
OECD Guideline 402 (Acute Dermal Toxicity)
Method and materials
In an acute dermal toxicity study, undiluted test material was applied to the shaved back and flanks of ten rats (5 males and 5 females) at a dose level of 2000 mg/kg bw. The test material was covered with a semi-occlusive dressing for a period of 24 hours. At the end of the exposure period any residual test material was removed and the animals were observed for 14 days.
Results
There were no deaths or clinical signs of toxicity during the study. Animals showed expected gains in bodyweight. Very slight erythema was noted at all treatment sites one and two days after dosing. Crust formation was noted at the treatment sites of three males and three females three to five days after treatment. Treatment sites appeared normal three or six days after treatment. Gross pathologic examination revealed nothing remarkable. The dermal LD50 of the test material in male and female rats has been determined to be greater than 2000 mg/kg bw.
Conclusion
In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for acute dermal toxicity
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