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EC number: 422-120-6 | CAS number: 166432-53-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
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- Stability: thermal, sunlight, metals
- pH
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
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- Nanomaterial specific surface area
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- Endpoint summary
- Stability
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- 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 (rabbit): non-irritating, EU Method B.4, 1995
Eye irritation, in vivo (rabbit): non-eye irritating, EU Method B.5, 1995
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:
- 29-11-1994 to 03-01-1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study performed under GLP. All relevant validity criteria were met.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute 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: Recognised animal supplier
- Age at study initiation: Adult
- Weight at study initiation: 4.3 – 4.9 kg
- Housing: Individually housed in grid bottomed metal cages
- Diet: certified rabbit diet ad libitum (details in the full study report)
- Water: filtered certified water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 -21
- Humidity (%): 47 - 67
- Air changes (per hr): Not reported, however reported as air conditioned
- Photoperiod: 12 hours light / 12 hours dark
IN-LIFE DATES: From: 29-11-1994 To: 14-12-1994 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5mL
- Concentration (if solution): Not applicable. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours (initial observation); additional observations are made daily up to and including on Days 7 and 15 to assess the reversibility of skin reactions (as appropriate).
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: dorsal
- Type of wrap if used: semi-occlusive ; gauze patch secured with semi-occlusive dressing and restraining bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, gently cleansed using cotton wool soaked in warm water.
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
1, 24, 48, 72 hours (initial observations); additional observations are made daily up to and including on Days 7 and 15 to assess the reversibility of skin reactions (as appropriate).
SCORING SYSTEM:
Consistent with Draize. Erythema and Eschar Formation:
No erythema ____________________________0
Very slight erythema (barely perceptible) _____1
Well-defined erythema ____________________2
Moderate to severe erythema ______________3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) _____________4
Oedema Formation
No oedema _____________________________0
Very slight oedema (barely perceptible) ______1
Slight oedema (edges of area well-defined by definite raising) _________________________2
Moderate oedema (raised approximately 1 millimetre) _________________________________3
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure) __4
Any other skin reactions and clinical signs of toxicity (clinical signs/behaviour), if present, were also recorded. - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 1h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 1h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 1h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 1h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 1h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 1h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- - Erythema: Slight or well defined erythema (score = 1 or 2) at all treated skin sites at 24 to 72 hours after patch removal and up to day 7. All effects reversed by day 14.
- Edema: Slight or moderated edema (score = 0, 1 or 2) was noted during the study and up to day 7. All effects reversed by day 14.
- Reversibility of effects: All effects reversed within 14 days (3/3 sites). - Other effects:
- - Other adverse local effects:
None reported
- Other adverse systemic effects: None reported. - Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study the test item is not considered to be irritating.
- Executive summary:
The study was performed to EU Method B.4 and/or a method equivalent or similar to OECD TG 404 under GLP to assess the primary skin irritancy potential of the test item in New Zealand White rabbits. Following single 4-Hour, semi-occluded applications to the intact rabbit skin. 0.5 mL of the test item was introduced under a square of surgical lint and placed in position on the clipped skin via semi-occlusive dressing to assess the irritancy potential of the test item. The surgical lint was secured in position with a strip of adhesive bandage. After 4 hours of exposure to the test item, the patches were removed, and individual dose sites were scored at approximately 1, 24, 48, and 72 hours. Daily observations were made up to day 14 as applicable. A single 4-Hour, semi occluded application of the test item to the intact skin of three rabbits produced slight or well-defined erythema (score = 1 or 2) and edema (score = 0, 1 or 2) at all treated skin sites at 24 to 72 hours after patch removal and up to day 7. Mean scores following grading at 24, 48 and 72h were 1.7, 2.0 and 1.3 in erythema and eschar and 1.0, 0.7 and 1.3 for the edema scoring criteria. All effects reversed by day 14. Under the conditions of the study, the test item is not considered to be a skin irritant.
Reference
Table 1. Individual skin reactions
Skin Reaction |
Observation Time |
Individual Scores |
||
|
|
1 (female) |
2 (female) |
3 (female) |
Erythema/Eschar formation |
1 hour |
0 |
0 |
1 |
|
24 hours |
1 |
2 |
1 |
|
48 hours |
2 |
2 |
1 |
|
72 hours |
2 |
2 |
2 |
|
7 days |
2 |
2 |
1 |
|
14 days |
0 |
0 |
0 |
|
|
|
|
|
Oedema formation |
1 hour |
1 |
0 |
0 |
|
24 hours |
1 |
0 |
2 |
|
48 hours |
1 |
1 |
1 |
|
72 hours |
1 |
1 |
1 |
|
7 days |
1 |
1 |
1 |
|
14 days |
0 |
0 |
0 |
|
|
|
|
|
Mean scores per organism at 24, 48 and 72h:
Erythemea/Escar Formation:
1: total = 5; mean score = 1.7
2: total = 6; mean score = 2.0
3: total = 4; mean score = 1.3
Oedema Formation:
1: total = 3; mean score = 1.0
2. total = 2; mean score = 0.7
3. total = 4; mean score = 1.3
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:
- 10-01-1995 to 27-01-1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study performed under GLP. All relevant validity criteria were met.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute 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: Recognised animal supplier
- Age at study initiation: Young adult
- Weight at study initiation: 2.6 – 2.9 kg
- Housing: Individually housed in grid bottomed metal cages
- Diet: certified rabbit diet ad libitum (details in the full study report)
- Water: filtered certified water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 -21
- Humidity (%): 35 - 60
- Air changes (per hr): Not reported, however reported as air conditioned
- Photoperiod: 12 hours light / 12 hours dark
IN-LIFE DATES: From: 10-01-1995 To: 14-01-1995 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- A volume of 0.1 mL of the test item, was placed into the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for a few seconds immediately and then moved gently to distribute the test item around the surface of the eye. The left eye remained untreated (and was used for control purposes).
- Observation period (in vivo):
- Ocular assessment was conducted at approximately 1, 24, 48 and 72 hours after instillation of the test item, according to numerical evaluation.
- Number of animals or in vitro replicates:
- 3 (sex not specified).
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): None
- Time after start of exposure: Not applicable.
SCORING SYSTEM:
The irritation was assessed using criteria consistent with Draize (1977) numerical scoring system. At each observation period, each eye was assessed for damage or irritation to the cornea, iris and conjunctiva using the untreated eye as a control.
TOOL USED TO ASSESS SCORE: Examination of the eye was facilitated by the use of the light from a standard light source according to BS 950 (artifical daylight for the assessment of colour). - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: mean; n=3
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: mean; n=3
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: mean; n=3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: mean; n=3
- Irritant / corrosive response data:
- No corneal or Iridial inflammation effects were noted. Very slight conjunctival reactions (redness, score = 1) was noted in treated eyes 1 hour after treatment. No chemosis effects were noted. All effects resolved within 24 hours observation.
- Other effects:
- - Lesions and clinical observations: None reported.
- Ophthalmoscopic findings: None reported.
- Histopathological findings: None reported.
- Effects of rinsing or washing: Not applicable.
- Other observations: None reported. - Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study the test item is not irritating to the eye.
- Executive summary:
The study was performed to EU Method B.5 and/or a method equivalent or similar to OECD TG 405 under GLP to assess the irritancy potential of the test item to the eye following a single application in the New Zealand White rabbit. A volume of 0.1 ml of the test item was placed into the left eye of three animals sequentially using the first as a sentinel. The other eye remained untreated and was used for control purposes. Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment. A single application of the test item to the non-irrigated eye of three rabbits produced no corneal or Iridial inflammation effects. Slight conjunctival reaction (hyperaemia or redness, score = 1 and/or discharge, score = 1) was noted in treated eyes at 1 hour after treatment. No chemosis effects were noted. All treated eyes appeared normal at the 24 hours observation point. Under the conditions of this study, the test item is not considered to be irritating to the eye.
Reference
Table 1. Individual scores and mean scores for 24, 48 and 72 hours
Organism number and sex |
Time after treatment |
Corneal Opacity |
Iridial Inflammation |
Conjunctival Redness |
Conjunctival Chemosis |
1 (sex not specified) |
1h |
0 |
0 |
1 |
0 |
|
24 h |
0 |
0 |
0 |
0 |
|
48 h |
0 |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
0 |
|
Day 4 |
- |
- |
- |
- |
Mean (24 – 72 h) |
|
0.00 |
0.00 |
0.00 |
0.00 |
|
|
|
|
|
|
2 (sex not specified) |
1h |
0 |
0 |
1 |
0 |
|
24 h |
0 |
0 |
0 |
0 |
|
48 h |
0 |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
0 |
|
Day 4 |
- |
- |
- |
- |
Mean (24 – 72 h) |
|
0.00 |
0.00 |
0.00 |
0.00 |
|
|
|
|
|
|
3 (sex not specified) |
1h |
0 |
0 |
1 |
0 |
|
24 h |
0 |
0 |
0 |
0 |
|
48 h |
0 |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
0 |
|
Day 4 |
0 |
0 |
0 |
0 |
Mean (24 – 72 h) |
|
0.00 |
0.00 |
0.00 |
0.00 |
|
|
|
|
|
|
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation:
Key study : In vivo, EU Method B.4, 1995 : The study was performed to EU Method B.4 and/or a method equivalent or similar to OECD TG 404 under GLP to assess the primary skin irritancy potential of the test item in New Zealand White rabbits. Following single 4-Hour, semi-occluded applications to the intact rabbit skin. 0.5 mL of the test item was introduced under a square of surgical lint and placed in position on the clipped skin via semi-occlusive dressing to assess the irritancy potential of the test item. The surgical lint was secured in position with a strip of adhesive bandage. After 4 hours of exposure to the test item, the patches were removed, and individual dose sites were scored at approximately 1, 24, 48, and 72 hours. Daily observations were made up to day 14 as applicable. A single 4-Hour, semi occluded application of the test item to the intact skin of three rabbits produced slight or well-defined erythema (score = 1 or 2) and edema (score = 0, 1 or 2) at all treated skin sites at 24 to 72 hours after patch removal and up to day 7. Mean scores following grading at 24, 48 and 72h were 1.7, 2.0 and 1.3 in erythema and eschar and 1.0, 0.7 and 1.3 for the edema scoring criteria. All effects reversed by day 14. Under the conditions of the study, the test item is not considered to be a skin irritant.
Eye Irritation:
Key study : In vivo, EU Method B.5, 1995 : The study was performed to EU Method B.5 and/or a method equivalent or similar to OECD TG 405 under GLP to assess the irritancy potential of the test item to the eye following a single application in the New Zealand White rabbit. A volume of 0.1 ml of the test item was placed into the left eye of three animals sequentially using the first as a sentinel. The other eye remained untreated and was used for control purposes. Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment. A single application of the test item to the non-irrigated eye of three rabbits produced no corneal or Iridial inflammation effects. Slight conjunctival reaction (hyperaemia or redness, score = 1 and/or discharge, score = 1) was noted in treated eyes at 1 hour after treatment. No chemosis effects were noted. All treated eyes appeared normal at the 24 hours observation point. Under the conditions of this study, the test item is not considered to be irritating to the eye.
Respiratory Irritation:
No study available
Justification for classification or non-classification
The substance does not meet classification criteria under Regulation (EC) No 1272/2008 for dermal irritation.
The substance does not meet classification criteria under Regulation (EC) No 1272/2008 for eye irritation.
For skin irritation, further in vitro skin corrosion testing does not need to be conducted based on the available information allowing a definitive conclusion on the classification of the substance. The substance does not demonstrate significant skin irritation potential necessary for classification and labelling within an available skin irritation in vivo assay (eq. or similar to OECD TG 404). The substance can cause pronounced transient mild irritation but which is not sufficient for classification and labelling.
For eye irritation, the weight of evidence indicates that the substance has the potential to cause transient irritating effects to the eye but which is not sufficient for classification based on the mean scoring and evaluation of the results in three organisms demonstrating that the EU criteria had not been met. Effects in vivo on corneal opacity and iritis are low to non-existent and conjunctival effects are low moderate which fully reversed within 24 hours; the overall evidence is indicative of transient mild effects on the eye.
References:
1. Guidance on Application of the CLP Criteria, ECHA, version 5.0, July 2017
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