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EC number: 262-979-2 | CAS number: 61788-48-5
- 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 vitro studies (corrosion and irritation) were not performed as sufficient in vivo data was available to address the endpoint without further testing. Two in vivo studies, performed in rabbits were available to address the data requirement for skin irritation and corrosion. Although both studies were not performed in line with currents guidelines, the data was considered sufficient to address the classification and labelling of the test material. The studies did not include a recovery period beyond 72 hours, however due to the number of reactions, the low reactions and the evidence of reversibility observed during the short observation period, it is expected that this material is not irritating to skin. Furthermore, corroborating evidence is available in the form of two acute dermal toxicity studies in the rat performed as limit tests with related compounds and a human irritation and skin sensitisation study, where human volunteers (53) were repeatedly dosed with the neat material. The three studies all demonstrated that the test material and the related analogues are not irritating to skin.
Eye irritation:
Two studies were available to evaluate the potential of the test material to cause serious eye damage and irritation. The studies were performed to methods equivalent to the current OECD 405 guidelines with no or minor deviations thought to impact the validity of the studies. Minimal ocular reactions were observed during the course of the two studies, and based on the available information, in line with the current irritation criteria, the test material was determined to be non-irritating to eyes.
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:
- July 7, 1976
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- To determine the effects of the test material when applied to the rabbit's skin designed similar to the Draize procedure as described in 16 CFR 1500.41.
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Not reported
- Type of coverage:
- occlusive
- Preparation of test site:
- other: The back of each animal was shaved free of hair; intact skin was exposed on the left half of the shaved area, and the abraded on the right half.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 mL or 0.5 g
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- up to 72 hours
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: back
- Type of wrap if used: A square patch of surgical gauze measuring 1 inch x 1 inch.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): None
- Time after start of exposure: N/A
OBSERVATION TIME POINTS
24 and 72 hours
SCORING SYSTEM:
- Method of calculation: Draize scoring Criteria:
- Primary Skin Irritantion Indexes of less than 2.0 are mild irritants.
- Primary Skin Irritantion Indexes of 2.0 to 5.0 are moderate irritants.
- Primary Skin Irritantion Indexes of greater than 5.0 are severe irritants. - Irritation parameter:
- erythema score
- Remarks:
- Intact skin
- Basis:
- animal #1
- Time point:
- other: 24/72 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Remarks:
- Abraded skin
- Basis:
- animal #1
- Time point:
- other: 24/72 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Remarks:
- Intact skin
- Basis:
- animal #2
- Time point:
- other: 24/72 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Remarks:
- Abraded skin
- Basis:
- animal #2
- Time point:
- other: 24/72 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Remarks:
- Intact Skin
- Basis:
- animal #3
- Time point:
- other: 24/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Remarks:
- Abraded skin
- Basis:
- animal #3
- Time point:
- other: 24/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Remarks:
- Intact skin
- Basis:
- animal #4
- Time point:
- other: 24/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Remarks:
- Abraded skin
- Basis:
- animal #4
- Time point:
- other: 24/72 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Remarks:
- Intact skin
- Basis:
- animal #5
- Time point:
- other: 24/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Remarks:
- Abraded skin
- Basis:
- animal #5
- Time point:
- other: 24/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Remarks:
- Intact skin
- Basis:
- animal #6
- Time point:
- other: 24/72 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Remarks:
- Abraded skin
- Basis:
- animal #6
- Time point:
- other: 24/42 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Remarks:
- Intact skin
- Basis:
- animal #1
- Time point:
- other: 24/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Remarks:
- Abraded skin
- Basis:
- animal #1
- Time point:
- other: 24/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Remarks:
- Intact skin
- Basis:
- animal #2
- Time point:
- other: 24/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Remarks:
- Abraded skin
- Basis:
- animal #2
- Time point:
- other: 24/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Remarks:
- Intact skin
- Basis:
- animal #3
- Time point:
- other: 24/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Remarks:
- Abraded skin
- Basis:
- animal #3
- Time point:
- other: 24/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Remarks:
- Intact Skin
- Basis:
- animal #4
- Time point:
- other: 24/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Remarks:
- Abraded skin
- Basis:
- animal #4
- Time point:
- other: 24/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Remarks:
- Intact skin
- Basis:
- animal #5
- Time point:
- other: 24/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Remarks:
- Abraded skin
- Basis:
- animal #5
- Time point:
- other: 24/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Remarks:
- Intact skin
- Basis:
- animal #6
- Time point:
- other: 24/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Remarks:
- Abraded skin
- Basis:
- animal #6
- Time point:
- other: 24/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- not specified
- Irritant / corrosive response data:
- Erythema was observed in the intact and abraded skin of five animals. Edema was observed in the intact and abraded skin of four animals. Erythema cleared in the intact and abraded skin of one animal, and edema cleared in the intact skin of three animals, and abraded skin of two animals during the 72-hour observation period.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was a mild irritant to the rabbit skin under the conditions of the test. However due to the low response and the reversibility observed in the non-abraded skin, the test material is concluded to be a non-irritant to skin based on the criteria as defined by Regulation EC 1272/2008 (CLP).
- Executive summary:
To skin irritation test was conducted to determine the effects of the test material (adminstered at 0.5 mL or 0.5g for 24 hours and observed at 24 and 72 hours) when applied to the rabbit's skin designed similar to the Draize procedure. The back of 6 rabbits were shaved free of hair; intact skin was exposed on the left half of the shaved area, and the abraded on the right half. Erythema was observed in the intact and abraded skin of five animals. Edema was observed in the intact and abraded skin of four animals. Erythema cleared in the intact and abraded skin of one animal, and edema cleared in the intact skin of three animals, and abraded skin of two animals during the 72-hour observation period. The test substance was a mild irritant to the rabbit skin. However due to the low response and the reversibility observed in the non-abraded skin, the test material is concluded to be a non-irritant to skin based on the criteria as defined by Regulation EC 1272/2008 (CLP).
Reference
Table 1: Results
Observation |
Test site |
Time (hours) |
Rabbit Number |
|||||
1 |
2 |
3 |
4 |
5 |
6 |
|||
Erythema and Eschar formation |
Intact skin |
24 |
2 |
2 |
1 |
1 |
0 |
1 |
72 |
1 |
1 |
0 |
1 |
0 |
2 |
||
Abraded skin |
24 |
2 |
2 |
1 |
2 |
0 |
1 |
|
72 |
1 |
1 |
0 |
1 |
0 |
2 |
||
Subtotal |
6 |
6 |
2 |
5 |
0 |
6 |
||
Oedema formation |
Intact skin |
24 |
1 |
1 |
0 |
1 |
0 |
0 |
72 |
0 |
0 |
0 |
0 |
0 |
1 |
||
Abraded skin |
24 |
0 |
1 |
0 |
1 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
0 |
1 |
||
Subtotal |
1 |
2 |
0 |
2 |
0 |
2 |
||
Erythema and oedema score |
Subtotal |
7 |
8 |
2 |
7 |
0 |
8 |
|
Primary irritation score |
1.75 |
2 |
1 |
3 |
0 |
2 |
||
Average = 1.62 |
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:
- 5 May 1970 to 24 June 1970
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Version / remarks:
- Draize "Appraisal of Safety of Chemicals in Foods, Drugs and Cosmetics," published by the Association of Food and Drug Officials of the United States; and the Code of Federal Regulations, Title 21, Part 191.12.
- Deviations:
- not specified
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- The purpose of the study was to determine the degree and nature of the irritation induced by the agent upon instillation into the eye of the rabbit.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- No information available.
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- undiluted, the test material was heated to 56 deg C for instillation.
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- 24 hours (single treatment and unwashed)
- Observation period (in vivo):
- Examined and the reaction evaluated at 24h, 48h, and 72h.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): unwashed
- Time after start of exposure: N/A
SCORING SYSTEM: Draize Scale for grading ocular lesions - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- 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:
- conjunctivae score
- Basis:
- animal #1
- 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
- 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:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- 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:
- chemosis 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:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Non-irritating to the rabbit eye.
- Executive summary:
Under the conditions of the study, the undiluted test substance, may be considered non-irritating to the rabbit eye. The elevated temperature to maintain the fluid state, had no apparent detrimental effect upon the eyes.
Reference
Table 1: Results
Animal No. |
Observation |
Time after administration |
||||
24 hours |
48 hours |
72 hours |
96 hours |
7 days |
||
1 |
Cornea - opacity |
0 |
0 |
0 |
0 |
0 |
Cornea - area |
0 |
0 |
0 |
0 |
0 |
|
Cornea - Score |
0 |
|||||
Iris |
0 |
0 |
0 |
0 |
0 |
|
Iris - score |
0 |
|||||
Conjunctivae - redness |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae - chemosis |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae - discharge |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae - Score |
0 |
|||||
2 |
Cornea - opacity |
0 |
0 |
0 |
0 |
0 |
Cornea - area |
0 |
0 |
0 |
0 |
0 |
|
Cornea - Score |
0 |
|||||
Iris |
0 |
0 |
0 |
0 |
0 |
|
Iris - score |
0 |
|||||
Conjunctivae - redness |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae - chemosis |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae - discharge |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae - Score |
0 |
|||||
3 |
Cornea - opacity |
0 |
0 |
0 |
0 |
0 |
Cornea - area |
0 |
0 |
0 |
0 |
0 |
|
Cornea - Score |
0 |
|||||
Iris |
0 |
0 |
0 |
0 |
0 |
|
Iris - score |
0 |
|||||
Conjunctivae - redness |
1 |
0 |
0 |
0 |
0 |
|
Conjunctivae - chemosis |
1 |
0 |
0 |
0 |
0 |
|
Conjunctivae - discharge |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae - Score |
4 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Justification for classification or non-classification
Based on the available information, the test material is not classified for skin or eye irritation in accordance with Regulation EC 1272/2008 (CLP).
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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