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EC number: 252-650-1 | CAS number: 35636-63-6
- 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 test material is not irritating to skin under test conditions. Since the test conditions were more stringent than required by OECD TG 404 (i.e. 24 h treatment, occlusive coverage, and scarified skin instead of 4 h treatment, semi-occlusive coverage, and intact skin) the test results are considered adequate to fulfill the endpoint requirements.
The test item did not reveal any remarkable irritation potential on the eyes of rabbits, tested in this study according to OECD test guideline no. 405 and GLP conditions.
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:
- From 31 AUG 1976 to 16 SEP 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: FDA guideline (minor deviations from OECD guideline)
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- other: FDA guideline (Federal register 38, No. 187, 27.9.1973, p.27019)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- study was performed previous to GLP implementation
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- weight at study initiation: 1.5 -2.0 kg
- Housing: single
- Diet: ERKA 8300, Robert Koch oHG/ Hamm, ad libitum
- Water: tap water, ad libitum - Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped intact and clipped scarified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg - Duration of treatment / exposure:
- 24 h
- Observation period:
- 48 h after removal of patch with observation time points immediately after removal and 24 h later.
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: gauze patch
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: erythema and edema scores ranging from 0-4.
Skin was evaluated immediately, 24 h and 48 h after after removal of the patch. Mean values of the readings 24 and 48 h after removal are reported in the results table. - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not relevant since no effect
- Remarks on result:
- other: clipped intact and clipped scarified
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not relevant since no effect
- Remarks on result:
- other: clipped intact and clipped scarified
- Irritant / corrosive response data:
- Immediately after removal of patch no erythema score could be determined due to coloration of the skin. Erythema scores at later time points were 0. No edema was detectable at any time point.
Results with scarified skin were the same. - Interpretation of results:
- GHS criteria not met
- Remarks:
- Regulation (EC) no. 1272/2008
- Conclusions:
- The test material is not irritating to skin under these test conditions.
This conclusion is legitimate even though the applied testing regime differs from today's standard methods. Since the test conditions were more stringent than required by OECD TG 404 (i.e. 24 h treatment, occlusive coverage, and scarified skin instead of 4 h treatment, semi-occlusive coverage, and intact skin) the test results are considered adequate to fulfill the endpoint requirements. - Executive summary:
The test material was tested for skin irritancy according to FDA guidelines. Both intact and scarified skin sites of six rabbits were exposed to 0.5 g test substance for 24 h under occlusive conditions and the skin responses were watched for 48 hours after end of exposure. No erythema or edema were seen at any time point (score 0). Immediately after removal of the patch no erythema score could be determined due to pigmet overlay. The test item is not irritating under these test conditions.
- 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:
- From 17 FEB 2004 to 27 FEB 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to Guideline (OECD 405) and GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, Kißlegg, Germany
- Weight at study initiation: 2.3 - 2.8 kg
- Housing: single in air conditioned room, cages arranged in battery
- Diet: ssniff K-H (V2333), ad libitum and hay (approx. 15 g daily)
- Water: tap water in plastic bottles, ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg - Duration of treatment / exposure:
- 24 h after application washing was performed
- Observation period (in vivo):
- 72 h with observation time points at 1, 24, 48 and 72 h.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): with isotonic saline at approx. 37 °C.
- Time after start of exposure: 24 h
SCORING SYSTEM: according to the score of Draize
TOOL USED TO ASSESS SCORE: not indicated, at the 24 and 72 h reading fluorescein was used additionally - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not relevant since no effect
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not relevant since no effect
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: #2 and #3 each
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not relevant since no effect
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not relevant since no effect
- Irritant / corrosive response data:
- Individual animal data for 1/24/48/72 h after application, animal #1, animal #2 animal #3:
cornea: 0/0/0/0, 0/0/0/0, 0/0/0/0
iris: 1/0/0/0, 0/0/0/0, 0/0/0/0
conjunctivae redness: 2/2/0/0, 2/0/0/0, 2/0/0/0
chemosis: 2/0/0/0, 1/0/0/0, 1/0/0/0
discharge: 2/0/0/0, 2/0/0/0, 2/0/0/0 - Interpretation of results:
- GHS criteria not met
- Remarks:
- Regulation (EC) 1272/2008
- Conclusions:
- The test item did not reveal any remarkable irritation potential on the eyes of rabbits, tested in this study according to OECD test guideline no. 405 and GLP conditions.
- Executive summary:
The primary eye irritation potential of the test item was investigated according to OECD test guideline no 405.The test item was applied by instillation of 0.1 g into the left eye of each of three young New Zealand White rabbits. The scoring of irritating effects was performed 1, 24, 48 and 72 hours after test item instillation.
The test item did not induce corneal effects under the conditions of this test. Effects on iris, conjunctivae redness and chemosis were sligtht to moderate (maximum score observed: iris =1; chemosis = 2 (1 -hour reading); conjunctival redness = 2 (1- and 24 - hour reading)) and fully reversible within 48 hours after start of the exposure.
- 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
Justification for classification or non-classification
No classification: No adverse effects observed
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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