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Diss Factsheets
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EC number: 443-950-5 | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 April 2002 to 01 May 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study was conducted in accordance with International Guidelines and in accordance with the principles of Good Laboratory Practise (GLP).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- 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
- Details on test material:
- - Name of test material (as cited in study report): NALCO 01WC026 / PSO
- Lot/batch No.:XC1M0642
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: approx 8 weeks old
- Weight at study initiation: Males 277 - 320g, Females 205 - 217 g
- Fasting period before study: None
- Housing: Individually housed in labelled Macrolon cages containing purified sawdust as bedding
- Diet (e.g. ad libitum): Free access to standard pelleted laboratory animal diet from Altromin (code VRF 1) Lage, Germany.
- Water (e.g. ad libitum): Free access to tap water
- Acclimation period: 5 day before start of treatment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3°C
- Humidity (%): 30 - 70%
- Air changes (per hr): approx 15
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: One day before exposure an area of approximately 5 x 7 cm on the back of the animal was clipped.
- % coverage: approx 10% of total body surface
- Type of wrap if used: surgical gauze coveed with aluminium foil and coban flexible bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the 24 hours contact period the dressings were removed and the skin cleaned of residual test substance using water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Dose level 2000mg/kg (1.47 ml/kg) bodyweight
-Specific gravity : 1.36
- Constant volume or concentration used: yes
VEHICLE - not applicable, test material used as supplied: - Duration of exposure:
- 24 hour contact period
- Doses:
- 2000mg/kg (1.47 ml/kg) bodyweight
- No. of animals per sex per dose:
- 5 Males and 5 Females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed immediately after dosing and at 2 and 4hours after dosing for signs of toxicity/ death and thereafter once daily (twice daily for mortality) for 14 days.Individual bodyweights were recorded on day 1 prior to dosing and on days 8 and 15.
- Necropsy of survivors performed: yes - Statistics:
- No statistical analysis was performed
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 occurred
- Mortality:
- There were no deaths.
- Clinical signs:
- other: Lethargy was noted in two males on days 1 and / or 2. No other signs of systemic toxicity were observed in the remaining animals. Erythema, scales and / or scabs were seen in the treated skin area of the animals during the observation period. Individual
- Gross pathology:
- No test substance related abnormalities were found at macroscopic post mortem examination of the animals.
Individual macroscopic observations are given in table 3 See attached file S7.2.3 Acute toxicity dermal results tables 1 - 3.pdf
Any other information on results incl. tables
Please refer to attached file S7.2.3 Acute toxicity dermal results tables 1 - 3.pdf for:
Table 1 - Individual clinical signs
Table 2 - Individual bodyweights
Table 3 - Individual macroscopic observations
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute dermal LD50 of the test substance in Wistar rats was found to be greater than 2000mg/kg bodyweight
- Executive summary:
The study was performed to assess the acute dermal toxicity of the test substance in the Wistar rat. The study was carried out based on the guidelines EEC Directive 92/69 EEC, B.3 "Acute Toxicity Dermal" and OECD Guideline no. 402 "Acute Dermal Toxicity"
Method
Five male and five female Wistar rats were given a single 24 hour, semi occluded dermal appliaction of the undiluted test substance to clipped intact skin at a dose level of 2000 mg/kg bodyweight. Animals were monitored for clinical signs, bodweights were determined weekly and a full macroscopic examination was performed after terminal sacrifice.
Mortality
There were no deaths.
Clinical signs
Lethargy was noted in two males on days 1 and / or 2. No other signs of systemic toxicity were observed in the remaining animals.
Erythema, scales and / or scabs were seen in the treated skin area of the animals during the observation period.
Bodyweight
Animals showed expected bodweight gains over the study period.
Necropsy
No test substance related abnormalities were found at macroscopic post mortem examination of the animals.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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