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Diss Factsheets
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EC number: 701-302-1 | 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1983-02-21 to 1983-03-07
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Guideline study reliable with restrictions - the purity and the stability of the test substance was not stated in the study report. In this study the test substance was not only tested on intact skin, but also in abraded skin. The results of the intact skin were reported in this endpoint study record. The results of the abraded skin were reported in the following endpoint study record: Section 7.3.1 Skin irritation / corrosion: s_Zechel_1983
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 1981-05-12
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Flußmittel Degussa h-Paste
- IUPAC Name:
- Flußmittel Degussa h-Paste
- Test material form:
- semi-solid (amorphous): gel
- Remarks:
- migrated information: paste
- Details on test material:
- - Name of test material (as cited in study report): Flußmittel Degussa h-Paste
- Physical state: white paste
- Density: 1.4 g/mL
- pH value: 8
Constituent 1
- Specific details on test material used for the study:
- The substance was initially pre-registered as EC 286-925-2 and this was the information reported in the analytical reports. Only after REACH SID refinements, the substance was correctly identified as an UVCB and required a refined EC entry. For this reason, the existing EC 286-925-2&name identifiers are reported in the testing material & in the testing robust study summaries
Test animals
- Species:
- rabbit
- Strain:
- other: White Russian (Albino)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Asta-Werke AG
- Age at study initiation: approx. 8-10 months
- Weight at study initiation: 2.1-2.2 kg
- Housing: caging: stainless steel cages type Asta; number of animals per cage: 1
- Diet: Standard test animal diet Altromin®
- Water (ad libitum): water
- Acclimation period: 1 day
ENVIRONMENTAL CONDITIONS
- Temperature: 22°C±1°C
- Relative humidity: 50-60%
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shorn skin
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g/patch - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours after removal of the bandage (maximum 14 days)
- Number of animals:
- 3 male rabbits
- Details on study design:
- TEST SITE
- Area of exposure / Type of wrap if used: the test substance was given on a wad of cotton, in order to ensure application without loss on the shorn dorsal skin area between shoulder and sacrum. The site of application was covered with an approximate 6.25 cm^2 linen cloth which adhered to a synthetic adhesive film. A bandage wrapped around the trunk (Acrylastic, supplied by P. Beiersdorf adn Co. AG, Hamburg, No. 2408, width 8 cm) provided occlusion. The dorsal skin area of each rabbit was subdivided into two areas on each side of the vertebral column (a total of 4). The contralateral areas differed from one another in that they consisted on the left side of uninjured (intact) skin and on the right side of artificially injured (sacrified) skin. Scarification took place solely superficially avoiding deeper defects and bleeding. Each of the 4 areas was covered with a patch of appropriate size; 2 patches served for covering the applied test product (one each on intact and sacrified region), 2 covered untreated skin regions at corresponding places.
SCORING SYSTEM: according to the Draize scale
Systemic toxic effects occurring were recorded.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Very slight oedema was observed at the 1 hour observation.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Very slight oedema was observed at the 1 hour observation.
- Irritant / corrosive response data:
- NOTE: The results of the intact skin were only stated in this result section. The results of the abraded skin were stated in the endpoint study record Section 7.3.1 Skin irritation / corrosion: s_Zechel_1983 (abraded skin).
The single application of 0.5 g Flußmittel Degussa h-Paste to the intact dorsal skin of the rabbit provoked erythemas and oedemas in 2 animals. In 1 animal neither erythema nor oedema was observed.
Erythemas occurred only 24 hours after the end of exposure and were assessed with gradings of 1 and 2 (very slight to well defined erythemas).
Oedemas, however, were immediately observed. They were seen at a maximum until day 2 of observation and obtained a grading of 1 (very slight oedemas).
Skin regions treated with solvent/suspension medium without test substance (control): without finding. - Other effects:
- Systemic toxic effects did not occur after dermal application of the test product. The general condition of the test animals was undisturbed.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item is not irritating to the skin.
According to the EC-Commission directive 67/548/EEC and its subsequent amendments, the test substance is not a skin irritant.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as skin irritant.
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