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Diss Factsheets
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EC number: 434-430-9 | 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:
- From 2000-03-23 to 2000-08-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
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: Harlan U.K.
- Age at study initiation: 8 to 11 weeks of age
- Weight at study initiation: 210 to 257 g
- Fasting period before study: No
- Housing: Individually in metal cages fitted with grid floors
- Diet (e.g. ad libitum): Standard laboratory rodent diet ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 21.5°C
- Humidity (%): 36 - 60% relative humidity
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light (0600 - 1800 hours GMT) in each 24-hour period
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- other: 1% w/v aqueous methylcellulose
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Dorso-lumbar region
- % coverage: approximately 10% of the total body surface area
- Type of wrap if used: waterproof dressing
REMOVAL OF TEST SUBSTANCE
- Removal of dressing: 24h post-exposure
- Washing: at 24h post-exposure, with warm water
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4.0 ml/kg bw
- Concentration (if solution): 500 mg/ml
- Constant volume or concentration used: yes
VEHICLE
- Concentration (if solution): 1% w/v aqueous methylcellulose
- Lot/batch no. (if required): no data
- Purity: no data - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- Ten Sprague-Dawley rats (five males and five females).
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: soon after dosing and on two occasions during the day (the day of study termination : only the morning)
- Frequency of weighing: on days 1, 8 and 15
- Necropsy of survivors performed: yes - Statistics:
- None
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occured in any animal throughout the study.
- Clinical signs:
- other: There were no evidence of a systemic response in any animal throughout the study.
- Gross pathology:
- No macroscopic abnormalities were observed for animals killed at study termination.
- Other findings:
- - Other observations:
Slight irritation (erythema with oedema up to grade 1) was notable in seven rats following removal of the dressings on Day 2. In the majority of instances, the skin irritation had resolved by Day 4, however, in two animals slight irritation persisted before finally resolving in both instances by either Day 6 or Day 11. In two animals, a localised response (spots/scabbing) was first notable from Day 5 and persisted in one animal through to study termination (Day 15).
Any other information on results incl. tables
Table 7.2.2/1: Number of animals dead and number with evident toxicity
Dose |
Conc. |
Mortality (# dead/total) |
Time range of deaths (hours) |
Number with evident toxicity(#/total) |
||||
Male |
Female |
Combined |
Male |
Female |
Combined |
|||
2000 |
500 mg/ml |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Mean erythema score for all animals:
at 24 hours: 0.7
at 48 hours: 0.4
at 72 hours: 0.2
Mean oedema score for all animals:
at 24 hours: 0.7
at 48 hours: 0
at 72 hours: 0
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The dermal LD50 of the test substance was higher than 2000 mg/kg bw in rats.
Therefore, the substance is not classified according to Regulation (EC) No. 1272/2008 and its subsequent amendments on classification, labeling and packaging (CLP) of substances and mixtures. - Executive summary:
The substance was tested for acute dermal toxicity study according to OECD 402 guideline and in compliance with Good Laboratory Practices. A group of ten rats (five males and five females) received a single topical application of the test substance formulated in 1% w/v aqueous methylcellulose and administered at a dosage of 2000 mg/kg bw. The application site was covered by a semi-occlusive dressing for 24 hours. Skin was washed with water at the end of the 24 -hour exposure period.
Examinations for mortality, clinical signs and body weight gain were performed during the 14-day observation period.
On completion of the observation period, the animals were sacrificed and then submitted to a macroscopic post-mortem examination.
No unscheduled deaths occurred during the study and no clinical signs were observed in any animals. Body weight was not affected by the treatment.
Slight irritation was notable in seven rats following removal of the dressings on Day 2. In the majority of instances, the skin irritation resolved by Day 4 excepted in two animals where slight irritation persisted up to Day 5 or Day 10. In two animals, localized response (spots/scabbing) was first notable from Day 5 and persisted up to the study termination on Day 15 for one animal.
At necropsy, there were no macroscopic findings related to the test item administration.
The acute dermal LD50 was found 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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