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EC number: - | CAS number: -
- 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 item was found to be non-irritant to skin or eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 and 72 h
- Score:
- 0.6
- Max. score:
- 1.5
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24/72 hrs
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24/72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24/72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- other: Did not resolve within 72 hours, no further observations were performed
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24/72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24/72 hours
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24/72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: 24/72 hours
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- other: 24/72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- other: 24/72 hours
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- other: 24/72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- other: 24/72 hours
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- other: 24/72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- See Table 1 for Skin reactions
- Other effects:
- No data.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: FHSA regulations
- Conclusions:
- To FHSA regulations, the test material is not a primary skin irritant
- Executive summary:
In a primary dermal irritation study in the rabbit male and female animals were dermally exposed to 0.5 ml of the substance for 24 hours. Animals were observed for 72 hours. Irritation was scores by the Draize classification scheme.
No corrosive effects were noted during the study and the substance produced a primary irritation index of 0.6.
The substance is not classified according to the FHSA regulations as non-irritant for skin.
Reference
Table 1: Individual Skin Reactions
Sex |
Animal No. |
Erythma |
Edema |
||
Intact site |
Abraded site |
Intact site |
Abraded site |
||
Male |
1 |
1.0 |
1.0 |
0 |
0 |
2 |
1.0 |
1.0 |
1.0 |
1.0 |
|
3 |
1.0 |
1.0 |
0 |
0 |
|
Female |
4 |
1.0 |
1.5 |
0 |
0 |
5 |
1.0 |
1.0 |
0 |
0 |
|
6 |
1.0 |
1.0 |
0 |
0 |
|
Average of 24 -hour |
1.0 |
||||
Average of 72-hour |
0.2 |
||||
Primary Irritation Index |
0.6 |
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:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.167
- Max. score:
- 4
- Reversibility:
- other: 72 hour score 0, 96 hour score 0.5.
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Other effects:
- None
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: FHSA regulations
- Conclusions:
- Test eyes treated with the substance did not exhibit ocular effects at all time points observed throughout the study. Following assessment of the data for all endpoints, the test material is not a primary eye irritant
- Executive summary:
In a study to evaluate the ocular irritancy potential of the substance using New Zealand White strain rabbit. The substance did not cause any ocular effects therefore it is not a primary eye irritant.
Reference
Table 1. Body Weight Data
|
Animal No. |
Initiation |
Terminal (day 7) |
Male |
1 |
2398 |
2527 |
2 |
2452 |
2592 |
|
3 |
2418 |
2511 |
|
Average |
2423 |
2543 |
|
Female |
4 |
2403 |
2482 |
5 |
2501 |
2409 |
|
6 |
2332 |
2333 |
|
Average |
2412 |
2408 |
Table 2. Individual Data for ocular Reactions
Sex |
Male |
Female |
|||||
Animal No. |
1 |
2 |
3 |
4 |
5 |
6 |
|
24 h |
Cornea - Opacity - area |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae - Redness - Chemosis - Discharge |
0 0.5 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0.5 0 0 |
1.0 0 0 |
|
48 h |
Cornea - Opacity - area |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae - Redness - Chemosis - Discharge |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0.5 0 0 |
0.5 0 0 |
|
72 h |
Cornea - Opacity - area |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae - Redness - Chemosis - Discharge |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
|
Sodium Fluorescein Examination |
-ve |
-ve |
-ve |
-ve |
-ve |
-ve |
|
96 h |
Cornea - Opacity - area |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae - Redness - Chemosis - Discharge |
0 0.5 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
|
Primary Eye irritation scores |
24 h: 0.7 48 h: 0.3 72 h: 0.3 96 h: 0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
The test item was evaluated for its irritating properties on skin and eyes of rabbits. It was found to be non-irritant to skin or eyes. The studies are found to be adequate to fufill the purposes of this endpoint.
Justification for classification or non-classification
There are conclusive but not sufficient data for classification of the test material with regard to irritation / corrosion.
The test material is not classified for these endpoints in accordance with the CLP Regulation (EC) No 1272/2008.
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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