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EC number: 479-310-7 | 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and appropriate guidelines
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- n/a
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- E-AF098T, Batch No. 474-0306-17, a white powder. Stored at room temp, dry, closed container.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Source: Harlan Italy s.r.l.
Rabbit, New Zealand White Specific Pathogen Free (SPF)
Number of animals and sex - 3 female rabbits (nulliparous and non-pregnant)
Age at order - 9 to 11 weeks old.
Weight range at arrival- 1.74 to 2.01 kg.
Husbandary: Daily average animal room temperature and relative humidity: 19± 2oC and 55±15%, respectively.
Light: 12 hr artificial light 12 hr dark.
Accommodation: Individually in labelled cages
Acclimatisation period was at least 5 days before start of the treatment
Diet- STANRAB (P) SQC, Special Diets Services, Witham, Essex CM8 3AD, UK ad libitum thorought the day.
Water- Drinking water was supplied to each cage via a water bottle ad libitum.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- 0.5g
- Duration of treatment / exposure:
- 4 h
- Observation period:
- Approximately 1, 24, 48 and 72 hours after the end of the 4 hour exposure period.
- Number of animals:
- 3 animals
- Details on study design:
- As the irritancy of the substance was unknown, a single animal was dosed to address potential irritation of the test item. As the response to treatment was considered to be within acceptable limits, a futher 2 animals were dosed, bringing the animal's group size to 3.
On the day before dosing a suitable test site was clipped free of hair on both sides of the mid-line of the dorsal surfaces of the trunk of each animal (approximately 15 x 10 cm).
The test item was used in the form suplied (solid), however, weighed aliquots of 0.5g were mixed to a paste using 0.5 ml of sterile water, just before dosing.
A quantity of 0.5 grams of the test material was spread evenly over a 2.5cmx 2.5cm cotton gauze pad and placed onto the animal's skin with the test item in direct contact with the skin. A strip of synthetic film was placed over the treated site and the whole assembly held in place by encircling the trunk of the animal with a length of elastic adhesive bandage. 4-hours after application the patches were removed and residual test material removed.
Mortality and morbidity were observed twice daily.
Bodyweight was taken on Day 1 and on termination (Day 4).
Skin reaction was scaled approximately 1, 24, 48 and 72 hours after the end of the 4 hour exposure period.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Reversibility:
- no data
- Remarks on result:
- other: No signs of dermal irritation were observed.Thus, no need to present data on reversibility.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Reversibility:
- no data
- Remarks on result:
- other: No signs of dermal irritation were observed.Thus, no need to present data on reversibility.
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Reversibility:
- no data
- Remarks on result:
- other: No signs of dermal irritation were observed.Thus, no need to present data on reversibility.
- Irritation parameter:
- erythema score
- Max. score:
- 0
- Reversibility:
- no data
- Remarks on result:
- other: Max. duration: d; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Reversibility:
- no data
- Remarks on result:
- other: No signs of dermal irritation were observed.Thus, no need to present data on reversibility.
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Reversibility:
- no data
- Remarks on result:
- other: No signs of dermal irritation were observed.Thus, no need to present data on reversibility.
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Reversibility:
- no data
- Remarks on result:
- other: No signs of dermal irritation were observed.Thus, no need to present data on reversibility.
- Irritation parameter:
- edema score
- Max. score:
- 0
- Reversibility:
- no data
- Remarks on result:
- other: Max. duration: d; Max. value at end of observation period: 0 (related to all animals)
- Irritant / corrosive response data:
- Corrosion: There was no evidence of a corrosive effect on the skin
Colouration: No staining of the treated skin by the test substance was observed
Toxicity/Mortality: There was no indication of a systemic toxicity effect in the animals during the test period and no mortality occurred.
Changes in body weight during the course of the study were not remarkable. - Other effects:
- No erythema or oedema was apparent following a 4 hour period
of exposure to the test item in any animal of the study.
There was no indication of a systemic effect. Soft
faeces and mucus were noted on litter tray of a single
animal at the 48 hour observation. These things were not
considered treatment-related. Changes in body weight during
the course of the study were not remarkable.
Any other information on results incl. tables
No further information.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information not classified Criteria used for interpretation of results: EU
- Conclusions:
- Based on these results and according to the EEC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC, 27th April 1993), E-AF098T (SOL-DP) does not have to be classified and has no obligatory labelling requirement for skin irritation.
- Executive summary:
n/a
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