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Diss Factsheets
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EC number: - | 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:
- 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- other: glittery semi-liquid
- Details on test material:
- Colour: orange
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- During the test, the animals (males) weighed 1.92 kg and 2.47 kg. At the beginning of the test, the animals were 10-11 weeks old.
Each animal was kept in an individual box installed in conventional air conditioned animal husbanding.
The temperature and relative humidity of the main test were controlled to remain within target ranges of 17 to 23°C and 30 to 70%, respectively.
The rate of air exchange was approximately thirteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (07.00 to 19.00) and twelve hours darkness.
Drinking water and foodstuff were supplied freely.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: On the opposite flank an untreated area was served as the control.
- Amount / concentration applied:
- The test item C.A.E. Code: 8500010 was applied, as supplied, at the dose of 0.5 mL.
- Duration of treatment / exposure:
- The undamaged skin area of one flank of each animal was exposed during 4 hours.
- Observation period:
- The skin reactions were appreciated 1 hour and then 24, 48 and 72 hours after removal of the patch.
If no reaction is observed 72 hours after treatment the study is terminated. In case of persistent reactions, additional observations can be carried out from D7 to D14 in order to determine the reversible character of the lesions observed. - Number of animals:
- 3 animals were treated sequentially.
Initially, a single animal was treated. After considerations of the cutaneous responses produced in the first animal on day 14, two additional animals were treated during 4 hours in the same experimental conditions.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 1.7
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other:
- Remarks:
- see conclusions
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other:
- Remarks:
- see conclusions
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other:
- Remarks:
- see conclusions
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other:
- Remarks:
- see conclusions
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other:
- Remarks:
- see conclusions
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other:
- Remarks:
- see conclusions
- Irritant / corrosive response data:
- A well defined erythema was noted on the treated area, 1 hour after the patch removal, and was totally reversible on day 7. A slight oedema was noted on the treated area, 1 hour after the patch removal, and was totally reversible between days 3 and 7.
On the cutaneous structure, dryness of the skin was noted from day 3 in one animal and from day 7 in two animals. The skin recovered a normal aspect on day 14 in two animals but the dryness of the skin was still noted on day 14 in one rabbit (end of the observations). - Other effects:
- None.
Any other information on results incl. tables
OBSERVATIONS | INDIVIDUAL DATA |
|||
Skin reactions | Observation time | Animal 1 | Animal 2 | Animal 3 |
Erythema and eschar | 24 hours | 2 | 1 | 1 |
48 hours | 2 | 1 | 1 | |
72 hours | 1 | 1 | 1 | |
MEAN | 1.7 | 1.0 | 1.0 | |
Oedema | 24 hours | 2 | 0 | 0 |
48 hours | 1 | 1 | 1 | |
72 hours | 1 | 0 | 0 | |
MEAN | 1.3 | 0.3 | 0.3 |
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- The results obtained, in these experimental conditions, enable to conclude that the test item C.A.E. Code: 8500010 must not be classified, according to the criteria for classification, packaging and labelling of dangerous substances and preparations in compliance with the E.E.C. Directives 67/548, 2001/59 and 1999/45. No symbol or risk phrase is required.
In accordance with the Regulation (EC) No.1272/2008, the test item must not be classified. No signal word or hazard statement is required. - Executive summary:
The test item C.A.E. Code: 8500010 was applied, as supplied, at the dose of 0.5 mL, under semi-occlusive dressing during 4 hours on an undamaged skin area of three New Zealand rabbits. The experimental protocol was established according to the OECD guideline No.404 dated April 24th, 2002 and the test method B.4 of the Council regulation No.440/2008 of 30 May 2008.
A well defined erythema was noted on the treated area, 1 hour after the patch removal, and was totally reversible on day 7. A slight oedema was noted on the treated area, 1 hour after the patch removal, and was totally reversible between days 3 and 7.
On the cutaneous structure, dryness of the skin was noted from day 3 in one animal and from day 7 in two animals. The skin recovered a normal aspect on day 14 in two animals but the dryness of the skin was still noted on day 14 in one rabbit (end of the observations).
The results obtained, in these experimental conditions, enable to conclude that the test item C.A.E. Code: 8500010 must not be classified, according to the criteria for classification, packaging and labelling of dangerous substances and preparations in compliance with the E.E.C. Directives 67/548, 2001/59 and 1999/45. No symbol or risk phrase is required.
In accordance with the Regulation (EC) No.1272/2008, the test item must not be classified. No signal word or hazard statement is required.
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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