Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 817-187-7 | CAS number: 1803088-15-4
- 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
Based on results of a GLP and OECD 404 compliant in vivo study, the test item is not considered to be skin irritating in rabbits. Furthermore, based on results of a GLP and OECD 405 compliant in vivo study, the test item is not considered to be eye irritating in rabbits.
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:
- 2016-06-08 to 2016-09-20
- 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)
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japan MAFF Testing Guideline of 12 Nousan No. 8147, as this is in line with OECD 404
- Version / remarks:
- 2000
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature; under light exclusion ; no direct sunlight - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Envigo CRS (Switzerland) Limited
- Age at study initiation: approx. 7-9 months
- Weight at study initiation: 3.70 - 4.51 kg
- Housing: individual housing
- Diet: STANRAB (P) SQC; SDS Special Diets Services, 67122 Altrip, Germany, ad libitum
- Water: Tap water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/- 3 °C
- Humidity: 30 - 70 %
- Air changes: approx. 10 per hr
- Photoperiod: 12 /12 hrs dark / hrs light - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g was loaded on the test patch (2.5 x 2.5 cm) - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: dorsolateral part of the trunk
- Type of wrap if used: The item was covered with a test patch and adhesive fleece
REMOVAL OF TEST SUBSTANCE
- Washing: The test item was removed at the end of the exposure period with polyethylenglycol
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
Immediately after removal of the patch, approx. 1, 24, 48, 72 h after removal of the patch
SCORING SYSTEM: Evaluation of skin reactions was performed according to the quoted guidelines.
- Method of calculation: For evaluation mean values of erythema and edema were calculated based on readings at 24, 48, 72 h. Calculations were performed using Microsoft Excel 2010 and checked with a calculator. - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Very slight erythema (grade 1) was observed in two animals immediately after removal of the patch and persisted until hour 1 or hour 24. The third animal was free of any findings. The cutaneous reactions were reversible in two animals within 24 or 48 hours after removal of the patch.
- Other effects:
- - Other adverse local effects: none
- Other adverse systemic effects: none - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Considering the described cutaneous reactions as well as the average score for irritation, the test item does not show a skin irritating potential under the test conditions chosen.
- Executive summary:
The potential of the test item to cause acute dermal irritation or corrosivity was assessed by a single topical application of an amount of 0.5 g of the test item for 4 hours to the intact skin of three New Zealand White rabbits (stepwise procedure starting with one animal and supplementing two additional animals), using a patch of 2.5 cm x 2.5 cm, covered with semi-occlusive dressing. After removal of the patch the application area was washed off. The cutaneous reactions were assessed immediately after removal of the patch, approximately 1, 24, 48 and 72 hours after removal of the patch. The following test item-related clinical observations were recorded during the course of the study: Very slight erythema (grade 1). The cutaneous reactions were reversible in two animals within 24 or 48 hours after removal of the patch. The third animal did not show any findings. Mean scores over 24, 48 and 72 hours for each animal were 0.3, 0.0 and 0.0 for erythema and 0.0, 0.0 and 0.0 for edema. Considering the described cutaneous reactions as well as the average score for irritation, the test article does not show a skin irritating potential under the test conditions chosen.
Reference
Table 1. Tabulation of irritant response data for each individual animal at each observation time as well as calculation of the means
Readings |
Animal No. |
Erythema |
Edema |
0 h |
1 |
1 |
0 |
2 |
0 |
0 |
|
3 |
1 |
0 |
|
1 h |
1 |
1 |
0 |
2 |
0 |
0 |
|
3 |
1 |
0 |
|
24 h |
1 |
1 |
0 |
2 |
0 |
0 |
|
3 |
0 |
0 |
|
48 h |
1 |
0 |
0 |
2 |
0 |
0 |
|
3 |
0 |
0 |
|
72 h* |
1 |
0 |
0 |
2 |
0 |
0 |
|
3 |
0 |
0 |
|
Mean 24 h – 72 h |
1 |
0.3 |
0.0 |
2 |
0.0 |
0.0 |
|
3 |
0.0 |
0.0 |
|
Mean |
- |
0.1 |
0.0 |
*Study discontinued because the animals were free of findings
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:
- 2016-06-08 to 2016-09-20
- 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
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japan/MAFF 8147
- Version / remarks:
- 2000
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature; under light exclusion ; no direct sunlight - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Envigo CRS (Switzerland) Limited
- Age at study initiation: approx. 3 months
- Weight at study initiation: 2.49 - 2.81 kg
- Housing: individual housing
- Diet: STANRAB (P) SQC; SDS Special Diets Services, 67122 Altrip, Germany, ad libitum
- Water: Tap water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/- 3 °C
- Humidity: 30 - 70 %
- Air changes: approx. 10 per hr
- Photoperiod: 12 / 12 hrs dark / hrs light - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL (about 17 mg of the comminuted test item)
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- approx. 1, 24, 48, 72 and 96 h after application
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: rinsing with 3 to 6 mL of lukewarm tap water for 1 to 2 minutes using a syringe with a blunt probe
- Time after start of exposure: 24 h
SCORING SYSTEM: according to guidelines and, in addition, evaluations were made of discharge from the eye and the area of cornea affected by the lesions:
Area of cornea involved (ar) Grading:
1 > 0 ≤ ¼
2 > ¼ < ½
3 > ½ < ¾
4 > ¾
Discharge (di) Grading:
0 No discharge
1 Slight: any amount different from normal (does not include small amounts observed in inner canthus of normal animals)
2 Obvious: discharge with moistening of the lids and hairs just adjacent to lids
3 Severe: discharge with moistening of the lids and hairs, and considerable area around the eye
TOOL USED TO ASSESS SCORE: hand-slit lamp, otoscope lamp and fluorescein - Irritation parameter:
- cornea opacity 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:
- cornea opacity score
- Basis:
- animal #3
- 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:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- 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 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No corneal lesions were noted in any animal at any examination time point. Even after instillation of a fluorescein solution no corneal lesions were detectable after 24 and 48 hours. Moderate iritis (grade 1) was observed in one animal 1 hour after application only. Slight conjunctival redness (grade1) was noted in all animals from 1 hour until hour 24 after application. Slight conjunctival chemosis (grade 1) was noted in two animals 1 hour after application. Additional findings like injected scleral vessels in a circumscribed or circular area were noted within 48 hours after application. The ocular reactions were reversible in all animals within 48 hours after application.
- Other effects:
- - Lesions and clinical observations: none
- Ophthalmoscopic findings: none
- Histopathological findings: not performed
- Effects of rinsing or washing: none - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Considering the described ocular reactions as well as the average score for irritation, the test item does not show an eye irritating potential under the test conditions chosen.
- Executive summary:
The potential of the test item to cause damage to the conjunctiva, iris or cornea was assessed by a single ocular application of 0.1 mL bulk volume (about 17 mg) of the undiluted test item to one eye of three New Zealand White rabbits (stepwise procedure starting with one animal and supplementing two additional animals). About, and not less than 24 hours after application the eye was rinsed with tap water. The ocular reactions were assessed approximately 1, 24, 48, 72 and 96 hours after application. Additional eye examinations were performed at 24 and 48 h after application with the instillation of a fluorescein solution. Due to absence of detectable lesions following fluorescein instillation, all subsequent readings were performed without the aid of fluorescein. No corneal lesions were noted in any animal at any examination time point. Even after instillation of a fluorescein solution no corneal lesions were detectable after 24 and 48 hours. The following test item-related clinical observations were recorded during the course of the study: Moderate iritis (grade 1), slight conjunctival redness (grade 1) and slight conjunctival chemosis (grade 1). Additional findings like injected scleral vessels in a circumscribed or circular area were noted in the animals within the first 48 hours. The ocular reactions were reversible in all animals within 48 hours after application. Mean scores calculated for each animal over 24, 48 and 72 hours were 0.0, 0.0 and 0.0 for corneal opacity and for iris lesions, 0.3, 0.3 and 0.3 for redness of the conjunctiva and 0.0, 0.0 and 0.0 for chemosis. Considering the described ocular reactions as well as the average score for irritation, the test article does not show an eye irritating potential under the test conditions chosen.
Reference
Table 1. Irritant response, data for each
individual animal at each observation time as well as calculation of the
mean
|
Cornea |
Iris |
Conjunctiva |
||||
Readings |
Animal No. |
Opacity |
Area of cornea involved |
Redness |
Chemosis |
Discharge |
|
1 h
|
1 |
0 |
0 |
0 |
1 |
0 |
0 |
2 |
0 |
0 |
1 |
1 |
1 |
0 |
|
3 |
0 |
0 |
0 |
1 |
1 |
0 |
|
24 h |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
2 |
0 |
0 |
0 |
1 |
0 |
0 |
|
3 |
0 |
0 |
0 |
1 |
0 |
0 |
|
48 h |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
0 |
0 |
|
72 h |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
0 |
0 |
|
96 h |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Mean 24 h- 72h |
1 |
0.0 |
- |
0.0 |
0.3 |
0.0 |
- |
2 |
0.0 |
- |
0.0 |
0.3 |
0.0 |
- |
|
3 |
0.0 |
- |
0.0 |
0.3 |
0.0 |
- |
|
Mean |
- |
0.0 |
- |
0.0 |
0.3 |
0.0 |
- |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation in vivo
The potential of the test item to cause acute dermal irritation or corrosivity was assessed by a single topical application of an amount of 0.5 g of the test item for 4 hours to the intact skin of three New Zealand White rabbits (stepwise procedure starting with one animal and supplementing two additional animals), using a patch of 2.5 cm x 2.5 cm, covered with semi-occlusive dressing. After removal of the patch the application area was washed off. The cutaneous reactions were assessed immediately after removal of the patch, approximately 1, 24, 48 and 72 hours after removal of the patch. Very slight erythema (grade 1) was observed in two animals. The cutaneous reactions were reversible in both animals within 24 or 48 hours after removal of the patch.The third animal did not show any findings. Mean scores over 24, 48 and 72 hours for each animal were 0.3, 0.0 and 0.0 for erythema and 0.0, 0.0 and 0.0 for edema. Considering the described cutaneous reactions as well as the average score for irritation, the test item does not show a skin irritating potential under the test conditions chosen.
Eye irritation in vivo
The potential of the test item to cause damage to the conjunctiva, iris or cornea was assessed by a single ocular application of 0.1 mL bulk volume (about 17 mg) of the undiluted test item to one eye of three New Zealand White rabbits (stepwise procedure starting with one animal and supplementing two additional animals). About, and not less than 24 hours after application the eye was rinsed with tap water. The ocular reactions were assessed approximately 1, 24, 48, 72 and 96 hours after application. Additional eye examinations were performed at 24 and 48 h after application with the instillation of a fluorescein solution.
Due to absence of detectable lesions following fluorescein instillation, all subsequent readings were performed without the aid of fluorescein.
No corneal lesions were noted in any animal at any examination time point. Even after instillation of a fluorescein solution no corneal lesions were detectable after 24 and 48 hours. The following test item-related clinical observations were recorded during the course of the study:
- Moderate iritis (grade 1)
- Slight conjunctival redness (grade 1)
- Slight conjunctival chemosis (grade 1)
Additional findings like injected scleral vessels in a circumscribed or circular area were noted in the animals within the first 48 hours.
The ocular reactions were reversible in all animals within 48 hours after application. Mean scores calculated for each animal over 24, 48 and 72 hours were 0.0, 0.0 and 0.0 for corneal opacity and for iris lesions, 0.3, 0.3 and 0.3 for redness of the conjunctiva and 0.0, 0.0 and 0.0 for chemosis.
Considering the described ocular reactions as well as the average score for irritation, the test item does not show an eye irritating potential under the test conditions chosen.
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. The test item revealed no eye irritating nor skin irritating potential in two in vivo studies, respectively. As a result the substance is not classified as skin or eye irritant under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.