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EC number: 252-335-9 | CAS number: 35044-59-8
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Guideline study performed under GLP. The source and target substances are isomeric. The structures differ only in the relative position of an alkyl group. The target and source share common structural elements in the same relative positions. The source and target have very similar physicochemical properties and thus have similar expected toxicokinetic behaviour. The substances have similar in silico chemical reactivity and toxicity predictions. This is observed within available in vivo toxicology testing where low level local and systemic toxicity is demonstrated and comparable between target and source. The substances therefore demonstrate chemical similarity.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- inspected August 2005; signature: November 2005
Test material
- Reference substance name:
- -
- EC Number:
- 482-180-4
- EC Name:
- -
- IUPAC Name:
- 482-180-4
- Test material form:
- gas under pressure: refrigerated liquefied gas
- Details on test material:
- - Physical state: liquid
- Storage condition of test material: approximately 4°C in the dark
- Other: Clear colourless.
Constituent 1
Test animals
- 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: 12 - 20 weeks
- Weight at study initiation: 2.0 - 3.5 kg
- Housing: Individually housed in suspended metal cages.
- Diet: certified rabbit diet ad libitum
- Water: mains drinking water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod: 12 hours light / 12 hours dark
Test system
- 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): Test material was used as supplied. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: dorsal
- Type of wrap if used: semi-occlusive
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, Four hours after application the corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: 4 hours
SCORING SYSTEM:
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
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: reaction extended 4 cm beyond treatment site in 2/3 organisms
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: reaction extended 4 cm beyond treatment site in 2/3 organisms
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: reaction extended 4 cm beyond treatment site and reported loss of skin elasticity in 2/3 organisms
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 7 day
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: Crust formation in 2/3 organisms
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 14 day
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: No effects reported at 14d
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 7 day
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 14 day
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: No effects reported at 14d
- Irritant / corrosive response data:
- - Erythema: Very slight erythema was noted at all treated skin sites one hour after patch removal with very slight to well-defined erythema noted at all treated skin sites at the 24, 48 and 72-hour observations. The erythematous reaction extended approximately 4 cm beyond the treatment sites of two animals at the 24, 48 and 72-hour observations.
- Oedema: Very slight oedema was noted at all treated skin sites at the 24 and 48-hour observations and at two treated skin sites at the 72-hour observation. Loss of skin elasticity was noted at two treated skin sites at the 72-hour observation with crust formation noted at these two treated skin sites at the 7 -day observation.
- Reversibility of effects: One treated skin site appeared normal at the 7 -day observation and the remaining two treated skin sites appeared normal at the 14-day observation.
Any other information on results incl. tables
Table 1. Individual skin reactions
Skin Reaction |
Observation Time |
Individual Scores |
||
|
|
1 (male) |
2 (male) |
3 (male) |
Erythema/Eschar formation |
1 hour |
1 |
1 |
1 |
|
24 hours |
1 |
2 R |
2 R |
|
48 hours |
1 |
2 R |
2 R |
|
72 hours |
1 |
2 RLe |
2 RLe |
|
7 days |
0 |
0 Cf |
0 Cf |
|
14 days |
0 |
0 |
0 |
|
|
|
|
|
Oedema formation |
1 hour |
0 |
0 |
0 |
|
24 hours |
1 |
1 |
1 |
|
48 hours |
1 |
1 |
1 |
|
72 hours |
0 |
1 |
1 |
|
7 days |
0 |
0 |
0 |
|
14 days |
0 |
0 |
0 |
|
|
|
|
|
Cf = crust formation
Le = Loss of skin elasticity
R = Erythematous reaction extends 4 cm beyond the treatment site
Mean scores per organism at 24, 48 and 72h:
Erythemea/Escar Formation:
1: total = 3; mean score = 1.0
2: total = 6; mean score = 2.0
3: total = 6; mean score = 2.0
Oedema Formation:
1: total = 2; mean score = 0.7
2. total = 3; mean score = 1.0
3. total = 3; mean score = 1.0
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study the test material is not considered to be irritating.
- Executive summary:
The study was performed to EU Method B.4 and OECD 404 to assess the primary skin irritancy potential of the test substance in accordance with GLP in New Zealand White rabbits. 0.5 ml of the test material was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin. The patch was secured in position with a strip of surgical adhesive tape. To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset and the animals were returned to their cages for the duration of the exposure period. After 4 hours of exposure to the test substance, the pads and collars were removed and the test sites were gently cleaned of any residual test substance with distilled water. Individual dose sites were scored according to the Draize scoring system at approximately 1, 24, 48, and 72 hours, 7 and 14 days after patch removal. Very slight erythema was noted at all treated skin sites one hour after patch removal with very slight to well-defined erythema noted at all treated skin sites at the 24, 48 and 72-hour observations which extended beyond the treatment area. Very slight oedema was noted at all treated skin sites at the 24 and 48-hour observations and at two treated skin sites at the 72-hour observation. Loss of skin elasticity was noted at two treated skin sites at the 72-hour observation with crust formation noted at these two treated skin sites at the 7 -day observation. One treated skin site appeared normal at the 7 -day observation and the remaining two treated skin sites appeared normal at the 14-day observation. Based on the applicant's recalculation of the mean scores following grading at 24, 48 and 72h, the mean scores did not meet the EU classification criteria under Regulation (EC) 1272/2008. The substance has the potential to produce mild transient skin irritation but is insufficient for classification. The substance cannot be considered a skin irritant.
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