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EC number: 479-390-3 | 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 479-390-3
- EC Name:
- -
- Cas Number:
- 42252-34-6
- Molecular formula:
- C4H8ClNO
- IUPAC Name:
- N-ethyl-N-methylcarbamoyl chloride
- Test material form:
- liquid
- Remarks:
- colourless.
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: C0014
- Purity: 99.3%
- Expiration date of the lot/batch: 31 July 3008
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: In refrigerator (2-8ºC) in the dark
- Stability under test conditions: stable
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan, Horst, The Netherlands
- Age at study initiation: At least 6 weeks old.
- Weight at study initiation: At least 1.0 kg.
- Housing:Individually housed in labelled cages with perforated floors.
- Diet (e.g. ad libitum): Pelleted diet for rabbits ad libitum.
- Water (e.g. ad libitum): Tap water ad libitum.
- Acclimation period: At least 5 days.
- Other: 3 male rabbits were used.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.9-21.7 ºC
- Humidity (%): 42-61 %
- Air changes (per hr): 15 air changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light/12 hours dark
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL. - Duration of treatment / exposure:
- Four hours
- Observation period:
- 14 days.
- Number of animals:
- Three
- Details on study design:
- TEST SITE
- Area of exposure: The test subtance was applied to the skin of one flank using a metalline path of 2x3cm.
- Type of wrap if used: The patch was mounted with Micropore tape and wrapped around the abdomen and secured with Coban elastic bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After removing the dressing, the skin was cleaned of residual test item with tap 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 (beef redness) to slight eschar formation (injuries in depth) preventing grading of erythema: 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 mm): 3
Severe oedema (raised more than 1 mm and extending beyond area of exposure: 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: At termination (14 days after treatment) very slight erythema, very slight oedema and bald skin was observed in one animal. In the other two animals scaliness and bald skin were observed at termination.
- Remarks on result:
- other: The individual score for each animal was the same to the mean score.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: At termination (14 days after treatment) very slight erythema, very slight oedema and bald skin was observed in one animal. In the other two animals scaliness and bald skin were observed at termination.
- Remarks on result:
- other: The individual score for each animal was the same to the mean score.
- Irritant / corrosive response data:
- There was no evidence of corrosion on the skin.
The skin reactions persisted until day 14 after exposure. - Other effects:
- Dry remnants of the test substance were present on day 1.
No staining of the treated skin by the test item was observed.
No signs of systemic toxicity were observed in the animals during the test period and no mortality occured.
Any other information on results incl. tables
Table 1. Individual skin irritation scores
Animal |
610 (1) |
626 |
632 |
||||||
Time after exposure |
Erythema |
Oedema |
Comments |
Erythema |
Oedema |
Comments |
Erythema |
Oedema |
Comments |
1 hour
|
2
|
3
|
B
|
2
|
4
|
B
|
2
|
3
|
B
|
24 hours |
2 |
3 |
- |
2 |
3 |
|
2 |
3 |
- |
48 hours |
2 |
3 |
- |
2 |
3 |
F |
2 |
3 |
F |
72 hours |
3 |
4 |
F |
3 |
4 |
F |
3 |
4 |
F |
7 days |
1 |
2 |
H, L |
1 |
2 |
H, L |
1 |
2 |
H, L |
14 days |
1 |
1 |
H |
0 |
0 |
H, L |
0 |
0 |
H, L |
(1)= Sentinel
Comments:
B: Dry remnants of the subtance present
F: Reduced Flexibility of the skin
H: Bald skin
L: Scaliness
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Remarks:
- EU
- Conclusions:
- The test item caused skin reactions which persisted until the end of the observation period (14 days). No evidence of corrosion was found.
- Executive summary:
A study was performed to assess the skin irritation potential of the test item to the rabbit in accordance to OECD Guideline 404 (GLP study).The study was performed in a stepwise manner and was started by the treatment of a single rabbit (sentinel). The other two animals were treated in a similar manner 4 weeks later, after considering the degree of skin irritation observed in the first animal. Rabbits received a single four hour, semi-occlusive, dermal administration of approximately 0.5 mL of the test substance as supplied and were observed for 14 days. No signs of corrosion were noted. At termination very slight erythema, very slight oedema and bald skin was observed in one animal. In the other two animals scaliness and bald skin were observed at termination. The observed mean scores (24, 48 and 72h) for each animal were equal to the mean for all animals and were 2.3 for erythema and 3.3 for oedema. The test item was determined to be irritating to the skin (Category 2 according to CLP Regulation).
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