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EC number: 917-473-2 | CAS number: 188416-34-4
- 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/corrosion
A skin irritation study (Parcell, 1997) is available which is key study. This study showed that the test substance is not irritating.
Eye irritation
An acute eye irritation study (Parcell, 1997) is available which is key study. This study showed that the test substance is moderately irritating.
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 29 May to 1 June 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study run to a method comparable with current guidelines and to GLP.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Interfauna UK Ltd., Huntingdon, Cambridgeshire, England
- Age at study initiation: 10-13 weeks of age
- Weight at study initiation: 2.4-2.8 kg
- Housing: Housed individually in metal cages with perforated floors
- Diet (e.g. ad libitum): A standard laboratory diet SDS Stanrab (P) Rabbit Diet
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Yes
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Approximately 19℃
- Humidity (%): 30-70%
- Air changes (per hr): Approximately 19 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light in each 24 hours period. - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution):
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 ml distilled water
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity: - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 4 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: Approximately 100 mm * 100 mm
- % coverage:
- Type of wrap if used: Each treatment site was covered with "Elastoplast" elastic adhesive dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treatment sites was washed with warm water (30 to 40 ℃) to remove any residual test substance.
- Time after start of exposure: 4 hours - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: Mean of 24, 48 & 72 hours
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: No reactions
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: Mean of 24, 48 & 72 hours
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: No reactions
- Irritant / corrosive response data:
- No dermal response to treatment was observed in any animal throughout the observation period.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- A single semi-occlusive application of this substance to intact rabbit skin for four hours elicited no dermal irritation.
Reference
There were no signs of toxicity or ill health in any rabbit during the observation period.
Rabbit number and sex |
E= Erythema O= Oedema |
Day |
|||
1* |
2 |
3 |
4 |
||
2894 ♂ |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
2895 ♂ |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
2896 ♂ |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
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 3 to 24 June 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study run to a method comparable with current guidelines and to GLP.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: 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: Harlan Interfauna UK Ltd, Huntingdon, Cambridgeshire, England
- Age at study initiation: Approximately 13 weeks of age
- Weight at study initiation: 3.2 kg
- Housing: Housed individually in metal cages with perforated floors
- Diet (e.g. ad libitum): A standard laboratory diet SDS Stanrab (P) Rabbit Diet
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Yes
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Approximately 19℃
- Humidity (%): 30-70%
- Air changes (per hr): Approximately 19 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light in each 24 hours period. - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Approximately 84 mg
- Concentration (if solution): - Duration of treatment / exposure:
- Single instillation without washing
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- Due to the low pH of the test material (pH 1.98), one animal was treated in advance of others to ensure that if a severe response was produced, no further animals would be exposed. As a result of the severity of ocular reactions observed, no further animals were treated.
Approximately 84 mg of the test substance, the weight occupying a volume of 0.1 ml, it was placed into the lower everted lid of one eye of each animal. The eyelids were then gently held together for one second before releasing.
The contralateral eye remained untreated. - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 3.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: No reactions
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #1
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: Blanching of nictating membrane
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 days
- Irritant / corrosive response data:
- Examination of the eye was made after 1 hour and 1, 2, 3, 4, 7, 14 and 21 days after instillation.
The numerical values given to the ocular reactions elicited by this substance are shown below. No iridial inflammation was observed. Corneal opacification (Grade 4) was noted within one hour of dosing.
A diffuse beefy red colouration of the conjunctivae was seen, accompanied by blanching of the nictating membrane and swelling with partial eversion of the eyelids. These responses gradually ameliorated and the eye was normal 21 days after instillation. - Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Instillation of the substance into the rabbit eye elicited corneal opacification and moderate conjuntival irritation.
Reference
There were no signs of toxicity or ill health in any rabbit during the observation period.
Rabbit number and sex |
Region of eye |
One hour |
Day after instillation |
||||||||
1 |
2 |
3 |
4 |
7 |
14 |
21 |
|||||
2885 ♂ |
Cornea |
Density |
4 |
4 |
3 |
3 |
3 |
1 |
0 |
0 |
|
Area |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
|||
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Conjunctiva |
Redness |
2a |
2a |
3a |
3a |
3a |
2 |
2 |
0 |
||
Chemosis |
2 |
2 |
2 |
2 |
2 |
2 |
1 |
0 |
Pilot animal
A Blanching of nictating membrane
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Skin irritation/corrosion:
A skin irritation study (Parcell, 1997) was conducted according to EU Method B4 which is key study. This study showed that the test substance is not irritating.
Eye irritation:
An acute eye irritation study (Parcell, 1997) was conducted according to EU Method B5 which is key study. This study showed that the test substance is moderately irritating.
Justification for selection of skin irritation / corrosion endpoint:
Study run to a method comparable with current guidelines and to GLP.
Justification for selection of eye irritation endpoint:
Study run to a method comparable with current guidelines and to GLP.
Effects on eye irritation: moderately irritating
Justification for classification or non-classification
Skin irritation/corrosion: Mean scores at 24, 48 & 72 hours for erythema were < 2.3 (actual value 0), for oedema were < 2.3 (actual value 0).
Serious eye damage/eye irritation: Mean scores at 24, 48 & 72 hours for corneal opacity were > 1 (actual value 3.33), for iritis were < 1 (actual value 0), for conjunctival redness were > 2 (actual value 2.67) and for conjunctival oedema were > 1(actual value 2).
Therefore in accordance with Regulation (EC) No. 1272/2008 Tables 3.2.2 & 3.3.2 the substance is not classified for the skin corrosion/irritation and classified as "Category 1" for serious eye damage/eye irritation endpoint.
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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