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EC number: 203-142-3 | CAS number: 103-76-4
- 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: irritating
eye irritation: irreversible effects
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (occlusive conditions, exposure period up to 20 hours)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 3.02 and 3.05 kg - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- undiluted test item applied on dorsal skin
- Duration of treatment / exposure:
- 1, 5 and 15 min and 20 h
- Observation period:
- 8 days
- Number of animals:
- 2 males
- Details on study design:
- TEST SITE
A cotton pad (2.5x2.5 cm) was covered with the undiluted liquid test substance and was applied under occlusive conditions onto the skin of the back.
REMOVAL OF TEST SUBSTANCE
- Washing: 1x Lutrol and 1x 50% Lutrol
- Time after start of exposure: Immediately after 1, 5 and 15 min exposure.
SCORING SYSTEM: The original BASF grading was converted into the numerical grading according the OECD Draize system. - Irritation parameter:
- erythema score
- Remarks:
- 1, 5 or 15 min exposure
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Remarks:
- 1, 5 or 15 min exposure
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Remarks:
- 20 h exposure
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- edema score
- Remarks:
- 20 h exposure
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Other effects:
- No mortality occurred and there were no signs of systemic toxicity from the dermal exposure.
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
Reference
Mean erythema score after 24, 48 and 72 h (animal1/2)
Exposure time | 24 h | 48 h | 72 h | mean |
1 min | 0/0 | 0/0 | 0/0 | 0/0 |
5 min | 0/0 | 0/0 | 0/0 | 0/0 |
15 min | 0/0 | 0/0 | 0/0 | 0/0 |
20 h | 3/3 | 3/3 | 3/3 | 3/3 |
Mean edema score after 24, 48 and 72 h (animal1/2)
Exposure time | 24 h | 48 h | 72 h | mean |
1 min | 0/0 | 0/0 | 0/0 | 0/0 |
5 min | 0/0 | 0/0 | 0/0 | 0/0 |
15 min | 0/0 | 0/0 | 0/0 | 0/0 |
20 h | 2/2 | 2/2 | 2/0 | 2/1.3 |
20 h treatment: erythema patchy or extending beyond the area of exposure, bleeding, incrustation, scaling.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (only 50 µL of the test substance were used and the observation period was 8 days)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 3.28 and 3.24 kg - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the adjacent eye served as saline-control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µL undiluted test ietm - Duration of treatment / exposure:
- Single application, eyes were not washed out.
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- 50 µL of the test substance were applied to the conjunctival sac of one eye in 2 animals. The animals were observed after 10 min, 1 and 3h on the day of treatment and up to 8 days afterwards. The report describes findings after 1 and 24 hours and at the end of the observation period.
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
Reference
Findings: animal1/animal2
Time | opacity | iritis | erythema | chemosis |
1 h | 3/3 | 2/2 | 2/2 | 1/2 |
24 h | 3/3 | 2/2 | 2/2 | 1/1 |
48 h | 3/3 | 2/2 | 2/2 | 1/1 |
72 h | 3/3 | 2/2 | 2/2 | 1/1 |
8 d | 3/3 | 2/2 | 2/2 | 0/0 |
The original BASF grading was converted into the numerical grading according the OECD Draize system.
Mean values over 24, 48, and 72 h
Animal 1: Erythema: 2 ; Opacity: 3; Chemosis: 1; Iritis: 2
Animal 2: Erythema: 2 ; Opacity: 3; Chemosis: 1; Iritis: 2
Additional observations: discharge with blood, staphyloma, marginal vascularization of the cornea, small retraction in the eyelid.
Severe corneal opacity and staphyloma formation are regarded as irreversible damage to ophthalmic tissue.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
In the key-study similar to OECD TG 404 the skin irritation potential of the test item was assessed. Two rabbits (Vienna White) were shaved and the undiluted liquid test item was applied for 1, 5 and 15 min or 20 h on the back of the animals under occlusive conditions. The observation period was 8 days. Immediately after exposure, the test item was removed by washing with 1x Lutrol and 1x 50% Lutrol. Scoring was done according to Draize. No mortality occurred and there were no signs of systemic toxicity from the dermal exposure. After short exposure times up to 15 min no skin reactions occurred. After 20 h exposure moderate to severe erythema was observed which was not fully reversible within 8 days. In addition, very slight to well-defined edema was observed, which was fully reversible within the observation period. The test item was irritating after 20 h occluded application (BASF, 1968).
In a supporting study according OECD TG 404 (1981) was performed to assess the irritating potential of the test item in vivo. The undiluted test item was applied on the clipped skin of three rabbits using a gauze patch, which was secured in position with a strip of surgical adhesive tape. After 4 hours exposure, the patches were removed and the test material was washed off with a cotton wool soaked in distilled water. Approximately 1 hour after removal, and 24, 48 and 72 hours later, the test sites were examined and scored according to Draize. Very slight to well-defined erythema was noted after 1 hour and 24 hours after patch removal. Very slight erythema was noted at one treatment site at the 48 hour observation and at all treatment sites at the 72-hour observation. Desquamation was noted at all treatment sites at the 7-day observation. Very slight edema was noted at all treatment sites one and 24-hours after patch removal and persisted at two treatment sites at the 48 and 72-hour observations. All reactions were fully reversible within 7 days. Under the conditions chosen in the study the test item was found to be non-irritant (Berol Nobel, 1990).
Eye irritation
In a study similar to OECD TG 405 the potential of the test substance to induce eye irritation was assessed. The test item (50µL) was applied to the conjunctival sac of one eye in each two rabbits (Vienna White) without washing out. The other eye served as saline control. The animals were observed after 10 min, 1h and 3 h on the day of treatment and up to 8 days afterwards. Scoring was converted from the original BASF grading into the numerical grading according to Draize.
Cornea opacity was observed which was not fully reversible after 8 days. The mean value over 24, 48 and 72 h was 3 for opacity in both animals. For erythema and iritis the mean value was 2.0 (not fully reversible after 8 days) and for chemosis 1.0 (fully reversible after 8 days). Additional observations were discharge with blood, staphyloma, marginal vascularization of the cornea, small retraction in the eyelid. Severe corneal opacity and staphyloma formation are regarded as irreversible damage to ophthalmic tissue (BASF AG, 1968).
Justification for classification or non-classification
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is considered to be classified as skin irritant under Regulation (EC) No 1272/2008, as amended for the ninth time in Regulation EC No 2016/1179. Based on the data, the test substance is classified as Skin Irritant Cat. 2 (H315: "Causes Skin Irritation") and Eye Irritant Cat 1 (H318: "Causes serious eye damage") under Regulation (EC) No 1272/2008, as amended for the ninth time in Regulation EC No 2016/1179.
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