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EC number: 203-183-7 | CAS number: 104-19-8
- 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
Endpoint summary
Administrative data
Description of key information
Skin irritation: A key primary skin irritation/corrosion study in rabbit is available. Based on the results, the substance is considered corrosive to the skin.
Eye irritation: no key study is available for this endpoint
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003-03-05 to 2003-03-05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Directive 92/69/EEC, 8.4: (Acute Toxicity - Skin Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: (MAFF); July 2000
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 922601
- Expiration date of the lot/batch: 2003-12-12
- Purity test date: Not indicated by the sponsor; treated as 100% pure
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Stability under test conditions: Not indicated
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
The test substance was applied undiluted as delivered by the sponsor.
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: 8-10 weeks
- Weight at study initiation: 1.883 grams
- Housing: Individually in labelled cages with perforated floors (Scanbur, Denmark, dimensions 56x44x37.5 cm)
- Diet (e.g. ad libitum): Standard laboratory rabbit diet
- Water (e.g. ad libitum): Free access to tap-water.
- Acclimation period: at least 5 days before start of treatment under laboratory conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±3°C
- Humidity (%): 30-70%
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light and 12 hours dark per day
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 0.5 ml
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- no details available, only 1 h
- Number of animals:
- 1 animal
- Details on study design:
- TEST SITE
- Area of exposure: 2x3 cm
- % coverage: approximately 150 square centimeters
- Type of wrap if used: Metalline patch
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After each removal of a dressing, the treated skin was cleaned of residual test substance using water
- Time after start of exposure: 1 hour
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) - approximately one hour after removal of patches and 24, 48 and 72 hours later
SCORING SYSTEM:
- Method of calculation: The irritation was assessed according to the following numerical scoring system. At each observation, the highest scores given were recorded:
Erythema and eschar formation:
No erythema - 0
Very slight erythema (barely perceptible) - 1
Well-defined erythema - 2
Moderate to severe erythema - 3
Severe erythema (beet redness) - 4
Where signs of necrosis or corrosion (injuries in depth) prevent erythema scoring, the maximum grade for erythema (= 4) is given.
Oedema formation:
No oedema - 0
Very slight oedema (barely perceptible) - 1
Slight oedema (edges of area well-defined by definite raising) - 2
Moderate oedema (raised approximately 1 millimeter) - 3
Severe oedema (raised more than 1 millimeter and extending beyond the area of exposure) - 4 - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- 3min treatment site
- Time point:
- other: immediately
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- 3 min treatment site
- Time point:
- other: immediately
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- 3 min treatment site
- Time point:
- other: 1 hour
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: grey discoloration, a sign of necrosis (superficial)
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- 3 min treatment site
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: grey discoloration, a sign of necrosis (superficial)
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- 1 hour and intended 4-hours treatment site
- Time point:
- other: immediately
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: wound with serious exudate on the edges of the treatment site; grey discoloration, a sign of necrosis (superficial)
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- 1 hour and 4 hours treatment site
- Time point:
- other:
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: wound with serious exudate on the edges of the treatment site; grey discoloration, a sign of necrosis (superficial)
- Irritant / corrosive response data:
- Three minutes of exposure to 0.5 ml resulted moderate to severe erythema and very slight oedema immediately after removal of the bandage. One hour of exposure on the designated 1 and 4 hours treatment sites resulted in severe erythema/necrosis and very slight oedema and in the treated skin-areas of the rabbit. A wound with serous exudate on the edges of the treatment site was observed on both the 1-hour and intended 4-hours treatment site.
Simultaneous scoring of the 3-minutes treatment site showed severe erythema/necrosis and very slight oedema 1 hour after removal of the bandage. - Other effects:
- - Other adverse local effects:
No staining of the treated skin by the test substance was observed
- Other adverse systemic effects:
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred - Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- Based on the results and according to the CLP Regulation, the substance is classified as corrosive to skin (Skin Corrosive 1B).
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance is classified as skin corrosion, leading to classification as serious eye damage (Category 1)
- Endpoint:
- eye irritation: in vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance is classified as skin corrosion, leading to classification as serious eye damage (Category 1)
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no study available
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin corrosion/irritation in vivo:
A key primary skin irritation/corrosion study with the test substance in the rabbit is available. This study was carried out according to OECD guideline 404. One rabbit was exposed to three samples of 0.5 mL of test substance applied to separate skin-sites on intact, clipped skin using a semi-occlusive dressing. The exposure periods were 3 minutes and 1 hour. Observations were made on all visible application sites immediately after removal of the bandages.
Three minutes of exposure to the test substance resulted in moderate to severe erythema and very slight edema immediately after removal of the bandage. One hour of exposure on the designated 1 and 4 hours treatment sites resulted in severe erythema/necrosis and very slight edema in the treated skin areas of the rabbit. A wound with serious exudate on the edges of the treatment site was observed on both the 1 -hour and intended 4 -hours treatment site. Simultaneous scoring of the 3 -minutes treatment site showed severe erythema/necrosis and very slight edema 1 hour after removal of the bandage.
Based on the results of the study, the observations were visible within 1 hour after a 3 minutes exposure period. This leads to a classification as skin corrosive category 1A according to CLP Regulation.
Skin irritation in vitro: no key in vitro skin irritation study is required as adequate in vivo data is available
Eye irritation: no key study is required as the substance is demonstrated to be corrosive to the skin.
Justification for classification or non-classification
The study is demonstrated to be corrosive to the skin and is thus classified as category 1A skin corrosive according to CLP Regulation.
Therefore, the substance is also classified as serious eye damage category 1.
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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