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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:
- Experimental start date: 26 January 2016 Experimental completion date 12 February 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- OECD Guideline for the Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion" (adopted 28 July 2015)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- Method B4 Acute Toxicity (Skin Irritation) of Commission Regulation (EC) No. 440/2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- other: yellow semi-solid
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- New Zealand White (Hsdlf:NZW)
- Details on test animals or test system and environmental conditions:
- Three New Zealand White (Hsdlf:NZW) strain rabbits were supplied by Envigo RMS (UK) Limited, Leicestershire, UK. At the start of the study the animals weighed 2.69 or 4.00 kg and were 12 to 20 weeks old. After an acclimatization period of at least 5 days each animal was given a number unique within the study which was written with a black indelible marker-pen on the inner surface of the ear and on the cage label.
The animals were individually housed in suspended cages. Free access to mains drinking water and food (2930C Teklad Global Rabbit diet supplied by Envigo RMS (UK) Limited, Oxon, UK) was allowed throughout the study. The diet and drinking water were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
The temperature and relative humidity were set to achieve limits of 17 to 23 °C and 30 to 70% respectively. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give 12 hours continuous light and 12 hours darkness.
The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- A quantity of 0.5 mL of the test item was applied directly to the skin
- Duration of treatment / exposure:
- Four hours
- Observation period:
- Immediately following removal of the patches and approximately 1, 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation
- Number of animals:
- 3
- Details on study design:
- Please see below
Results and discussion
In vivo
Results
- Irritation parameter:
- other: Erythema/Eschar Formation
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.23
- Max. score:
- 2
- Reversibility:
- not fully reversible within:
- Remarks on result:
- other: The test item produced individual mean scores of 2.0, 1.0 and 0.7 for erythema
- Remarks:
- Very slight erythema, with or without very slight edema, were noted at all treated skin sites immediately after patch removal. Well-defined erythema and slight edema were noted at one treated skin site and very slight erythema and very slight edema were noted at two treated skin sites 1 hour after patch removal. Well-defined erythema and slight edema were noted at one treated skin site and very slight erythema, with or without very or slight edema, were noted at two treated skin sites at the 24 and 48-Hour observations. Well-defined erythema and very slight edema were noted at one treated skin site and very slight erythema was noted at one other treated skin site at the 72-Hour observation. At the 72-Hour observation, light brown discoloration of the epidermis and loss of skin elasticity were also noted at one treated skin site and slight desquamation was noted at one other treated skin site. Slight desquamation and glossy skin were noted at one treated skin site at the 7-Day observation.
- Irritant / corrosive response data:
- Very slight erythema, with or without very slight edema, were noted at all treated skin sites immediately after patch removal. Well-defined erythema and slight edema were noted at one treated skin site and very slight erythema and very slight edema were noted at two treated skin sites 1 hour after patch removal. Well-defined erythema and slight edema were noted at one treated skin site and very slight erythema, with or without very or slight edema, were noted at two treated skin sites at the 24 and 48-Hour observations. Well-defined erythema and very slight edema were noted at one treated skin site and very slight erythema was noted at one other treated skin site at the 72-Hour observation.
At the 72-Hour observation, light brown discoloration of the epidermis and loss of skin elasticity were also noted at one treated skin site and slight desquamation was noted at one other treated skin site. Slight desquamation and glossy skin were noted at one treated skin site at the 7-Day observation.
Any other information on results incl. tables
Skin Reactions
The individual scores and mean scores for erythema/eschar and edema are given in the attached Appendix 1.
Very slight erythema, with or without very slight edema, were noted at all treated skin sites immediately after patch removal. Well-defined erythema and slight edema were noted at one treated skin site and very slight erythema and very slight edema were noted at two treated skin sites 1 hour after patch removal. Well-defined erythema and slight edema were noted at one treated skin site and very slight erythema, with or without very or slight edema, were noted at two treated skin sites at the 24 and 48-Hour observations. Well-defined erythema and very slight edema were noted at one treated skin site and very slight erythema was noted at one other treated skin site at the 72-Hour observation.
At the 72-Hour observation, light brown discoloration of the epidermis and loss of skin elasticity were also noted at one treated skin site and slight desquamation was noted at one other treated skin site. Slight desquamation and glossy skin were noted at one treated skin site at the 7-Day observation.
The third treated skin site appeared normal at the 72-Hour observation and one of the initial treated skin sites appeared normal at the 7-Day observation.
BodyWeight
Individual body weights and body weight change are given in the attached Appendix 2. All animals showed expected gain in body weight during the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item produced individual mean scores of 2.0, 1.0 and 0.7 for erythema and 1.7, 1.0 and 0.3 for edema.
- Executive summary:
Introduction
The study was performed to assess the irritancy potential of the test item to the skin of the New Zealand White rabbit.
Results
A single 4-Hour, semi occluded application of the test item to the intact skin of three rabbits produced very slight to well-defined erythema and very slight to slight edema. Other skin reactions noted were light brown discoloration of the epidermis, loss of skin elasticity, slight desquamation and glossy skin. One treated skin site appeared normal at the 72-Hour observation and one other treated skin site appeared normal at the 7-Day observation. No corrosive effects were noted.
Conclusion
The test item produced individual mean scores of 2.0, 1.0 and 0.7 for erythema and 1.7, 1.0 and 0.3 for edema.
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