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EC number: 701-392-2 | 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
Skin irritation in vivo
The test material is not irritating to the skin of rabbits (equivalent or similar to 16 CFR 1500.41 of the Federal Hazardous Substances Act Regulations)
Eye irritation in vivo
The test material is not irritating to the eyes of rabbits (equivalent or similar to 16 CFR 1500.41 of the Federal Hazardous Substances Act Regulations)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Remarks:
- In vivo testing previously conducted before in vitro rules came into force
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1980-12-9 to 1980-12-12
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- 24 hour exposure and termination at 72 hours without evidence of reversibility
- Justification for type of information:
- Test conducted prior to the introduction of in vitro methods.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Section 1500.41- Federal Hazardous Substances Act Regulations - 16 CFR
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- 24 hour exposure to the test material
- Principles of method if other than guideline:
- Six albino rabbits were clipped and then one side of the back was abraded to penetrate the stratum corneum with the other side kept intact. A 0.5 mL portion of the test material was applied to an abraded and an intact skin site of the same rabbit. A gauze patch was placed over each application site and an impervious material was wrapped around the trunk of the animal to hold the patches. The wrapping was removed after 24h. Treated areas were examined at 24h after treatment and scoring using the Draize method was done at 72h after treatment.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- No data
- Type of coverage:
- occlusive
- Preparation of test site:
- other: abraded and intact
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 24 hour
- Observation period:
- 72 hours
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: back
- % coverage: not specified
- Type of wrap if used: gauze patch covered by impervious material.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
SCORING SYSTEM: Draize - Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- animal #1
- Time point:
- other: mean 24/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- abraded skin
- Basis:
- animal #1
- Time point:
- other: mean 24/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- animal #2
- Time point:
- other: Mean 24/72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- abraded skin
- Basis:
- animal #2
- Time point:
- other: mean 24/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- animal #3
- Time point:
- other: mean 24/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- abraded skin
- Basis:
- animal #3
- Time point:
- other: mean 24/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- animal #4
- Time point:
- other: mean 24/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- abraded skin
- Basis:
- animal #4
- Time point:
- other: mean 24/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- animal #5
- Time point:
- other: mean 24/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- abraded skin
- Basis:
- animal #5
- Time point:
- other: mean 24/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- animal #6
- Time point:
- other: mean 24/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- abraded skin
- Basis:
- animal #6
- Time point:
- other: mean 24/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- animal #1
- Time point:
- other: mean 24/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- abraded skin
- Basis:
- animal #1
- Time point:
- other: mean 24/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- animal #2
- Time point:
- other: mean 24/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- abraded skin
- Basis:
- animal #2
- Time point:
- other: mean 24/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- animal #3
- Time point:
- other: mean 24/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- abraded skin
- Basis:
- animal #3
- Time point:
- other: mean 24/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- animal #4
- Time point:
- other: mean 24/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- abraded skin
- Basis:
- animal #4
- Time point:
- other: mean 24/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- Intact skin
- Basis:
- animal #5
- Time point:
- other: mean 24/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- abraded skin
- Basis:
- animal #5
- Time point:
- other: mean 24/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- animal #6
- Time point:
- other: mean 24/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- abraded skin
- Basis:
- animal #6
- Time point:
- other: mean 24/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- - Very slight erythema was observed at the intact skin in two and three animals at 24 and 72 hours, respectively. Whereas in abraded skin, very slight erythema was observed in three and four animals at 24 and 72 hours, respectively. At 24 and 72 hours, very slight edema was observed in intact skin of three animals. At 24 and 72 hours, very slight edema was observed in abraded skin of two and three animals, respectively; whereas slight edema was observed in abraded skin of one animal at 24 and 72 hours.
- There was no evidence of reversibility over the limited timeframe of the study. - Other effects:
- No data
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material is not irritating to the skin of rabbits under the conditions of the study. In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for skin irritation.
- Executive summary:
Test Guidance
Skin irritation study performed by a similar method to 16 CFR 1500.41 of the Federal Hazardous Substances Act Regulations.
Method and Material
Six albino rabbits were clipped and then one side of the back was abraded to penetrate the stratum corneum with the other side kept intact. A 0.5 mL of the test material was applied to an abraded and an intact skin site of the same rabbit. A gauze patch was placed over each application site and an impervious material was wrapped around the trunk of the animal to hold the patches. The wrapping was removed after 24 hours. Treated areas were examined for erythema and edema using the Draize method of scoring at 24 and 72 hours.
Results
Very slight erythema was observed at the intact skin in two and three animals at 24 and 72 hours, respectively. Whereas in abraded skin, very slight erythema was observed in three and four animals at 24 and 72 hours, respectively. At 24 and 72 hours, very slight edema was observed in intact skin of three animals. At 24 and 72 hours, very slight edema was observed in abraded skin of two and three animals, respectively; whereas slight edema was observed in abraded skin of one animal at 24 and 72 hours. There was no evidence of reversibility over the limited timeframe of the study.
Conclusion
In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for skin irritation.
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Endpoint:
- skin irritation: 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
Table 7.3.1/1: Primary skin irritation
Erythema and Eschar Formation |
Reading (hrs) |
Rabbit number |
Average |
|||||
1 |
2 |
3 |
4 |
5 |
6 |
|||
Intact Skin |
24 |
1 |
1 |
0 |
0 |
0 |
0 |
0.33 |
Intact Skin |
72 |
1 |
1 |
1 |
0 |
0 |
0 |
0.50 |
Abraded Skin |
24 |
1 |
1 |
1 |
0 |
0 |
0 |
0.50 |
Abraded Skin |
72 |
1 |
1 |
1 |
0 |
0 |
1 |
0.67 |
Subtotal |
2.00 |
|||||||
Edema Formation |
||||||||
Intact Skin |
24 |
1 |
1 |
1 |
0 |
0 |
0 |
0.50 |
Intact Skin |
72 |
1 |
1 |
1 |
0 |
0 |
0 |
0.50 |
Abraded Skin |
24 |
1 |
2 |
1 |
0 |
0 |
0 |
0.67 |
Abraded Skin |
72 |
1 |
2 |
1 |
0 |
0 |
1 |
0.83 |
Subtotal |
2.50 |
|||||||
Total |
4.50 |
|||||||
Primary irritation score |
1.13 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Remarks:
- In vivo testing previously conducted before in vitro rules came into force
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1980-12-02 to 1980-12-09
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- details on test animals and environmental conditions not reported.
- Justification for type of information:
- In vivo testing previously conducted before introduction of in vitro methods.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Section 1500.42- Federal Hazardous Substances Act Regulations - 16 CFR
- Deviations:
- yes
- Remarks:
- details on test animals and environmental conditions not reported
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Six albino rabbits were used in this study. A 0.1 mL of the test material was instilled into the right eyes of the test animals while the other eyes remained untreated to serve as controls. The test material was not washed from the eyes. The treated eyes were examined at 1, 2, 3, 5 and 7 days and scoring using the Draize method.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- No data
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- Eyes were not rinsed throughout study
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
SCORING SYSTEM: Draize method - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No eye irritation was observed.
- Other effects:
- No data
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material is not irritating to the eyes of rabbits under the conditions of the study. In accordance with EU CLP Regulation No. 1272/2008 classification of this substance is not required for eye irritation.
- Executive summary:
Test Guidance
Eye irritation study performed by a similar method to 16 CFR 1500.42 of the Federal Hazardous Substances Act.
Method and Material
0.1 mL of the test material was instilled into the right eye of six young adult albino rabbits. The left eye served as the untreated control. The test material was not washed from the eye. Treated eyes were examined at 1, 2, 3, 5 and 7 days following treatment. Interpretation of results was made in accordance with the Draize scale.
Results
No sign of eye irritation was observed in any of the treated animals up to the 7 days observation period.
Conclusion
In accordance with EU CLP Regulation No. 1272/2008 classification of this substance is not required for eye irritation.
- 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
Table 7.3.2/1: Observations
Rabbit Number |
Cornea |
Iris |
Conjunctivae |
Chemosis |
||||||||
24 h |
48 h |
72 h |
24 h |
48 h |
72 h |
24 h |
48 h |
72 h |
24 h |
48 h |
72 h |
|
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
6 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Mean Total |
0.0 |
0.0 |
0.0 |
0.0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin corrosion in vitro
An in vitro skin corrosion study does not need to be conducted because adequate data from an in vivo skin irritation study are available.
Skin irritation in vitro
An in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available.
Skin irritation in vivo
The Skin irritation study was performed by a similar method to 16 CFR 1500.41 of the Federal Hazardous Substances Act Regulations.
Six albino rabbits were clipped and then one side of the back was abraded to penetrate the stratum corneum with the other side kept intact. A 0.5 mL of the test material was applied to an abraded and an intact skin site of the same rabbit. A gauze patch was placed over each application site and an impervious material was wrapped around the trunk of the animal to hold the patches. The wrapping was removed after 24 hours. Treated areas were examined for erythema and edema using the Draize method of scoring at 24 and 72 hours.
Very slight erythema was observed at the intact skin in two and three animals at 24 and 72 hours, respectively. Whereas in abraded skin, very slight erythema was observed in three and four animals at 24 and 72 hours, respectively. All scores were below a positive score for irritation and only three out of six animals indicate very slight erythema (grade 1) in intact skin. At 24 and 72 hours, very slight edema was observed in intact skin of three animals. At 24 and 72 hours, very slight edema was observed in abraded skin of two and three animals, respectively; whereas slight edema was observed in abraded skin of one animal at 24 and 72 hours. There was no evidence of reversibility over the limited timeframe of the study.
Topical range finding tests in the Buehler study conducted in accordance with OECD 406 demonstrated that the test material was well tolerated and as such, the induction exposures were performed with the neat material.
In addition, dermal irritation observations in the acute dermal toxicity study performed with rats in accordance with OECD 402 indicated no irritation with the undiluted material with a contact time of 24 hours.
In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for skin irritation.
Eye irritation in vitro
An in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available.
Eye irritation in vivo
The eye irritation study performed by a similar method to 16 CFR 1500.42 of the Federal Hazardous Substances Act.
0.1 mL of the test material was instilled into the right eye of six young adult albino rabbits. The left eye served as the untreated control. The test material was not washed from the eye. Treated eyes were examined at 1, 2, 3, 5 and 7 days following treatment. Interpretation of results was made in accordance with the Draize scale.
No sign of eye irritation was observed in any of the treated animals up to the 7 days observation period.
In accordance with EU CLP Regulation No. 1272/2008 classification of this substance is not required for eye irritation.
Justification for classification or non-classification
Under the conditions of the studies, the test material is not irritating to the skin or the eye of rabbits. In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for irritation effects
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