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Diss Factsheets
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EC number: 700-136-7 | 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
- Study period:
- January 15 to 24, 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented and reported study, conducted according to internationally accepted technical guidelines and in compliance with GLP in recognized contract research organization.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- of 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- of 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- of 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147, November 2000, including the most recent partial revisions.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation (day of dosing): 9 - 12 weeks.
- Number and Sex: 3 males
- Animal supplier: Harlan France SARL, Gannat, France
- Weight at study initiation( before application): Minimum 1780 g, maximum 2340 g.
- Housing: Individual housing in cages with perforated floor and with shelters.
- Diet (approx. 100 g/day): Commercially available pelleted rabbit diet (K-H from SSNIFF® Spezialdiäten GmbH, Soest, Germany).
- Hay (at least 3 times/week): Supplier: TecniLab-BMO BV, Someren, The Netherlands)
- Water (ad libitum): Tap water
- Acclimation period: At least 5 days before treatment start under laboratory conditions.
ENVIRONMENTAL CONDITIONS
Animal housing and environmental conditions were appropriate for skin irritation / corrosion testing in the rabbit: Controlled environment with approximately 15 air changes per hour, 12 hours artificial fluorescent light and 12 hours darkness per day and 21 – 23ºC. The relative humidity during the study period was 40 – 71%.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: twice clipped with electric clipper
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- 0.5 g test substance* moistened with 0.5 ml water per approx. 6 cm2 skin per animal.
* Dose expressed as water- and minor impurity-free test substance. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours post patch removal
- Number of animals:
- 3
- Details on study design:
- TEST SITE PREPARATION:
Approximately 24 hours before exposure an area of approximately 10x15 cm on the back of the animal was clipped. Area foreseen for treatment was re-clipped approx. 3 hours before treatment start to facilitate evaluation of the skin reactions. During health inspection of the animals prior to commencement of treatment, special attention was paid to the skin to be treated, which was intact and free from any abnormality.
- Area of treated skin: Approx. 6 cm2 (= 2x3 cm).
- Type of wrap used: Metalline patch (2x3 cm) mounted on micropore tape which was wrapped around the abdomen
and secured with Coban elastic bandage.
TEST MATERIAL AND DOSE PREPARATION
- Administration Volume/animal (2x3 cm):
0.5 g the test substance (expressed as water- and minor impurity-free test substance) moistened with 0.5 ml of water (= vehicle).
- Vehicle: Water (Elix, Millipore S.A.S., Molsheim, France).
- Justification for choice of vehicle:
The test substance is well soluble in water and stable for at least 96 hours in water and no adverse side effects of this vehicle on the animals
are to be expected
TREATMENT PERIOD AND REMOVAL OF TEST SUBSTANCE
Semi-occlusive treatment lasted 4 hours. Then the dressings were removed and residual test substance was washed off the skin with tap-water
and ethanol diluted with water (50% v/v) and acetone diluted with water (50% v/v).
SCORING SYSTEM:
The treated skin patches were evaluated at 1 hour post end of exposure (not included in the mean dermal irritation score nor used for irritation/corrosion classification) and at 24, 48 and 72 h post end of exposure (included in the mean dermal irritation score and used for irritation/corrosion classification).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- according to Draize as defined in Table 1
- Basis:
- mean
- Remarks:
- over 3 animals and 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Remarks:
- according to Draize as defined in Table 1
- Basis:
- animal #1
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Remarks:
- according to Draize as defined in Table 1
- Basis:
- animal #2
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Remarks:
- according to Draize as defined in Table 1
- Basis:
- animal #3
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Remarks:
- according to Draize as defined in Table 1
- Basis:
- mean
- Remarks:
- over 3 animals and 3 time points
- Time point:
- other: 24, 48,72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h (edema grade 1 seen at 1 hour post patch removal)
- Irritant / corrosive response data:
- Erythema and edema result table (Table 2) for each individual animal is presented under "Remarks on results including tables and figures"
- Other effects:
- No other effects were reported. Mortality, symptoms of systemic toxicity or adverse effects on bodyweight were not evident.
Any other information on results incl. tables
Table 2: Gradings of Skin Reactions Attained for each Animal at Different Observation Time Points |
||||
Time after Patch Removal |
1 h |
24 h |
48 h |
72 h |
Animal (Identification) No. |
1 2 3 |
1 2 3 |
1 2 3 |
1 2 3 |
Erythema |
* 1 1 |
1 1 1 |
0 0 0 |
0 0 0 |
Edema |
1 1 1 |
0 0 0 |
0 0 0 |
0 0 0 |
* scoring was not possible, because of yellow/orange staining of the treated skin area.
Yellow/orange staining of the skin by the test substance was evident at 1, 24 and 48 hours after patch removal in all animals.
In all animals, the very slight erythema seen at 24 hours after patch removal were restricted to the edges of the application area.
At the end of the 4-hour treatment period the patches adhered to the skin resulting in bald skin at the edges of the application area in all animals. Bald skin at the edges of the application area was seen in all animals at all observation time points.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The mean Draize score for erythema derived from 24, 48 and 72 hours post patch removal in 3 rabbits was 0.3, the respective mean score for edema was 0.0. All edema findings were completely reversible within 24 and all erythema findings within 48 hours after patch removal. Based on these findings and according to EU classification rules [DIRECTIVE 67/548/EEC and REGULATION (EC) 1272/2008] the test substance was considered "not irritant" and not having any labelling requirement regarding skin irritation.
- Executive summary:
the test substance was tested for skin irritation according to OECD Guideline 404 and the corresponding EC, EPA-OPPTS and JMAFF Technical Guidelines in compliance with GLP. Reliability grade 1 was assigned to the study.
Each of three New Zealand White rabbits was treated for 4 hours by semi-occlusive administration of a single dose of 0.5 g test substance* moistened with 0.5 ml water. The test substance was administered to clipped intact skin (approximately 6 cm2/animal). Skin reactions were assessed 1, 24, 48 and 72 hours post patch removal.
At 1 h post patch removal, edema, very slight in degree, were evident in all animals and erythema, very slight in degree, in two of them. In the other animal, erythema evaluation was impeded by considerable yellow/orange staining of the treated skin by the test substance. By Day 2 (24 h after treatment), the edema had completely resolved and only very slight erythema restricted to the edges of the application area were observed in all animals. By 48 h after treatment the signs of skin irritation had completely resolved in all animals. Yellow/orange staining of the skin by the test substance was evident at 1, 24 and 48 hours after patch removal in all animals, but was no longer evident at 72 h. Adherence of the patches to the skin and their removal led to bald skin at the edges of the application area in all animals. The latter was seen in all animals at all observation time points. Mortality, signs of systemic toxicity or adverse effects on bodyweight were not evident.
In view of complete reversibility of the irritating effects within 48 hours after patch removal and according to EU classification rules [DIRECTIVE 67/548/EEC and REGULATION (EC) 1272/2008] the test substance was considered "not irritant" and not having any labelling requirement regarding skin irritation.
________________________________________________________________
* Expressed as water- and minor impurity-free test substance
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