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EC number: 234-679-1 | CAS number: 12023-27-7
- 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
Acute skin irritation was studied in rabbits using intact skin under occlusive conditions according to OECD 404 (reference 7.3.1 -1). Given the results, no evidence for irritation/corrosion was observed. Studies on eye irritation were performed in rabbits according to OECD 405 (reference 7.3.2 -1). No adverse effects were observed thus indicating that undiluted substance is not irritating to the eyes.
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
- Study period:
- 1990-02-19 until 1990-03-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: SAVO-Ivanovas, Kisslegg
- Sex: 1 male and 2 females
- Age at study initiation: 16 - 17 weeks
- Mean weight at study initiation: 2.84 kg
- Housing: single in cages type KK 017
- Diet: ad libitum, Altromin Standard Diet TPF 2113
- Water: ad libitum, acidified, fully demineralized water
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23 °C
- Humidity (%): 42 - 55 %
- Photoperiod (hrs dark / hrs light): 12 / 12 hours - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 3 hours after removal of the patches, and then daily for a period of 8 days.
- Number of animals:
- 3 animals
- Details on study design:
- TEST SITE
- Area of exposure: 24 hours before treatment the backs and flanks of the animals were cautiously shaved with an electric clipper, so that the skin stayed intact.
- Type of wrap: The application sites were wrapped with polyethylene foil which was kept on place by a leather sleeve.
REMOVAL OF TEST SUBSTANCE
- Washing: After 4 hours of occlusive exposure the patches were removed and any test material left was wiped off.
OBSERVATION TIME POINTS
The rabbits were investigated for skin alterations, behaviour, and general conditions 3 hours after removal of the patches, and then daily for a period of 8 days.
SCORING SYSTEM:
- Method of calculation: Skin changes at the application site were evaluated according to Draize. - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No indication for skin irritation was observed at any time point.
- Other effects:
- - Other adverse local effects:
Only brown discoloration of the skin was observed on day 1 and 2 of the study due to the coloration of the test item.
- Other adverse systemic effects: All animals survived the observation period. No signs of systemic toxicity were detected. The body weight development of the treated rabbits was inconspicuous. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- No skin irritating potential could be detected.
- Executive summary:
The acute skin irritation potential was investigated in three White New Zealand rabbits (1 male and 2 females) following application on the intact skin according OECD TG 404. Aliquots of neat test material (0.5 g) were moistened with water and applied to the intact skin of each rabbit for a 4-hour period under occlusive conditions. The rabbits were examined for skin reactions three hours after removal of the patches and then daily up to eight days. Skin reactions were evaluated and graded according to Draize. No signs of skin irritation were observed at any time point. Based on this study the test item is considered not to be irritating to the skin.
- Endpoint:
- skin corrosion: 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
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990-02-19 until 1990-03-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: SAVO-Ivanovas, Kisslegg
- Sex: 2 male and 1 females
- Age at study initiation: 16 - 17 weeks
- Mean weight at study initiation: 2.88 kg
- Housing: single
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23 °C
- Humidity (%): 42 - 55 %
- Photoperiod (hrs dark / hrs light): 12 / 12 hours - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Untreated eye remained as control
- Amount / concentration applied:
- 0.1 g
- Duration of treatment / exposure:
- Rinsing of the eyes were not performed
- Observation period (in vivo):
- 1 hour after treatment and then daily up to 8 days
- Number of animals or in vitro replicates:
- 3 animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no
- Time after start of exposure: The rabbits were investigated for eye irritation and for changes in behavior and general condition 1hour after treatment and then daily for a period of 8 days.
SCORING SYSTEM: Local changes of the eye were evaluated according to Draize.
TOOL USED TO ASSESS SCORE: fluorescein
24 hours before treatment ophthalmological examinations were performed after instillation of 0.15% fluorescein solution. - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Other effects:
- - Lesions and clinical observations:
All animals survived the observation period. No signs of systemic toxicity were seen. The body weight development of the treated rabbits was inconspicuous.
- Other observations: Only brown discoloration of the hairs around the eyes was observed on day 1 and 2 of the study due to the coloration of the test item. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- No eye irritating potential could be detected.
- Executive summary:
The test material was tested according OECD TG 405 for acute eye irritation in three New Zealand White rabbits (2 males and 1 female). Aliquots of 0.1 g were applied into the conjunctival sac of the left eye of each rabbit. The right eye remained untreated and served as a control. The rabbits were examined for eye irritation daily up to day 8 of the study. Eye reactions were evaluated and graded according to Draize scale. After instillation of the test material, no irritancy was observed in all animals. Based on the results of this study, undiluted test substance is evaluated as non-irritating to the eyes.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin
The acute skin irritation potential was investigated in three White New Zealand rabbits (1 male and 2 females) following application on the intact skin according OECD TG 404. Aliquots of neat test material (0.5 g) were moistened with water and applied to the intact skin of each rabbit for a 4-hour period under occlusive conditions. The rabbits were examined for skin reactions three hours after removal of the patches and then daily up to eight days. Skin reactions were evaluated and graded according to Draize. No signs of skin irritation were observed at any time point. Based on this study the test item is considered not to be irritating to the skin.
Eyes
The test material was tested according OECD TG 405 for acute eye irritation in three New Zealand White rabbits (2 males and 1 female). Aliquots of 0.1 g were applied into the conjunctival sac of the left eye of each rabbit. The right eye remained untreated and served as a control. The rabbits were examined for eye irritation daily up to day 8 of the study. Eye reactions were evaluated and graded according to Draize scale. After instillation of the test material, no irritancy was observed in all animals. Based on the results of this study, undiluted test substance is evaluated as non-irritating to the eyes.
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No 1272/2008
The available data for skin and eye irritation are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on this data, the substance is not considered to be classified for skin and eye irritation under Regulation (EC) No 1272/2008, as amended for the twelfth time in Regulation (EU) 2019/521.
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