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EC number: 684-879-1 | CAS number: 848641-69-0
- 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
The registration substance was tested for its skin irritant properties in New Zealand White rabbits. The study was performed according to OECD Guideline 404.With reference the reported scores it is concluded that the registration substance does not have to be classified as irritant to the skin according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
An in vivo eye irritation study in rabbits was conducted with the test substance. The studies were conducted according to OECD Guideline 405.
With reference the reported scores the registration substance does not have to be classified as irritant to the eyes according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
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:
- Nov 2016
- 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:
- 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Yellow liquid
Batch no.: Batch 1.3
20% water (Correction factor 1.25) - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Manfred Bauer Kaninchen, 74632 Neuenstein, Germany
- Age at study initiation: approx. 8.5 months
- Weight at study initiation: 3.5 - 3.9 kg
- Housing: individually in cages measuring 380 mm x 425 mm x 600 mm
- Diet (e.g. ad libitum): ssniff k-H V 2333 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany), ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 30 - 70%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES:
From: 07.11. To: 29.11.2016 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- other: the surrounding untreated skin served as a control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.625 mL
- Concentration (if solution): pure
VEHICLE
- Amount(s) applied (volume or weight with unit): n.a.
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): no required
POSITIVE CONTROL
- Amount(s) applied (volume or weight): not required - Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 days
readings: 60 min, 24, 48, 72 h, 7 and 14 d after patch removal - Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: approx. 6 cm(2)
- % coverage: 100
- Type of wrap if used: gauze patch
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
- Time after start of exposure: n.a.
OBSERVATION TIME POINTS
(indicate if minutes, hours or days)
60 min, 24, 48, 72 h, 7 and 14 days after patch removal
SCORING SYSTEM: 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:
- Under the present test conditions, none of the three rabbits exposed for 4 hours to 0.625 mL of the test item (semi-occlusive conditions) revealed any skin reaction.
- Other effects:
- There were no systemic intolerance reactions.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to GHS and EC regulation 1272/2008 the test item is non-irritating.
- Executive summary:
The test substance was tested for its skin irritant properties in 3 New Zealand White rabbits. Due to the water content of 20% 0.625 mL of the substance were applied to the clipped skin. None of the three rabbits exposed for 4 h revealed any skin reaction. There were no systemic intolerance reactions.
Reference
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:
- Nov - Dec 2016
- 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:
- 2012
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Yellow liquid
Batch no.: Batch 1.3
20% water (Correction factor 1.25) - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Manfred Bauer Kaninchen, 74632 Neuenstein, Germany
- Age at study initiation: approx. 8.5 months
- Weight at study initiation: 3.8 - 4.8 kg
- Housing: individually in cages with dimensions of 380 mm x 425 mm x 600 mm
- Diet (e.g. ad libitum): ssniff K-H V2333 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany), ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES:
From: 07.11. To: 07.12.2016 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.125 mL
- Concentration (if solution): 80 %
Due to the water content of the test item of 20% a correction factor of 1.25 was used.
VEHICLE
no vehicle utilised - Duration of treatment / exposure:
- No washing of the eye after application of test substance performed
- Observation period (in vivo):
- The eyes were examined ophthalmoscopically with a slit lamp prior to the administra-tion and 1, 24, 48, 72 hours and 7, 14 and 21 days after the administration.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
- Time after start of exposure: n.a.
SCORING SYSTEM:
According to Draize scale
TOOL USED TO ASSESS SCORE:
One day before and 24 hours after administration, fluorescein was applied to the eyes before being examined to aid evaluation of the cornea for possible lesions. The fluorescein test was repeated on each day of observation. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Conjunctival redness (grade 1) was observed in all animals 1 hour after administration.
The corneae and the irises were not affected by administration of the test item. - Other effects:
- There were no systemic intolerance reactions.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to EC Regualtion 1272/2008 the test item is non-irritating to the eye. Classification and labelling are not necessary.
- Executive summary:
The test substance was tested for its eye irritant potential in rabbit eyes according to OEC 405.
Under the present test conditions, a single instillation of 0.125 mL test item into the conjunctival sac of the right eye of 3 rabbits caused the following changes: Conjunctival redness (grade 1) was observed in all animals 1 hour after administration.
The corneae and the irises were not affected by administration of the test item.
There were no systemic intolerance reactions.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
With reference the reported absence of any effects it is concluded that the registration substance does not have to be classified, neither as irritant to the skin nor as eye irritating according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
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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