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Diss Factsheets
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EC number: 700-934-5 | 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
- Study period:
- November 06, 2007 to November 17, 2007 (experimental)
- 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- reaction products of ethylene glycol, urea and paraformaldehyde
- EC Number:
- 700-934-5
- Molecular formula:
- No exact molecular formula can be given for a complex reaction mixture (UVCB substance).
- IUPAC Name:
- reaction products of ethylene glycol, urea and paraformaldehyde
- Details on test material:
- - Name of test material (as cited in study report): TPI 1618
- Substance type: Formaldehyde releaser
- Physical state: Colourless liquid
- Analytical purity: 100%
- Composition of test material, percentage of components: Reaction product of ethylene glycol, urea and paraformaldehyde
- Lot/batch No.: 1118965
- Expiration date of the lot/batch: December 2008
- Storage condition of test material: dry, room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Chbb:HM (russian)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, 88353 Kißleg
- Age at study initiation: 17 to 35 months
- Weight at study initiation: 2.7 – 2.8 kg
- Housing: individually in PPO cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +-3
- Humidity (%): up to 70
- Air changes (per hr): 10
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: Nov 06, 2007 To: Nov 17, 2007
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied. 0.5 mL/animal - Duration of treatment / exposure:
- 3 min, 1 hour, 4 hours as preliminary assessment
4 hours in three main study aniamls - Observation period:
- Skin reactions were recorded: after 1, 4, 24, 48 and 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: adhesive Gothaplast
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: after 4 hours
SCORING SYSTEM: Scoring system based on 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
eschar formation preventing grading
of erythema 4
-- Total possible erythema score 4
Edema formation:
- No edema 0
- Very slight edema (barely perceptible) 1
- Slight edema (edges of area well defined
by definite raising 2
- Moderate edema (raised approx. 1mm) 3
- Severe edema (raised more than 1 mm and
extending beyond the area of exposure 4
-- Total possible edema score 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- none
Any other information on results incl. tables
Table for results of skin irritation study
score (average of 3 animals investigated) |
time |
Erythema |
Edema |
average score |
1 h |
0.0 |
0.0 |
24 h |
0.0 |
0.0 |
|
48 h |
0.0 |
0.0 |
|
72 h |
0.0 |
0.0 |
|
average score |
24h, 48 and 72h |
0.0 |
0.0 |
reversibility: * |
n.a. |
n.a. |
|
average time for reversibility |
n.a. |
n.a. |
|
n.a. : not applicable |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was not irritating to skin of rabbits and thus, is not subject of classification.
- Executive summary:
Skin irritation test in rabbits, according to OECD guideline 404, with three rabbits. Potential skin irritating properties were investigated on the intact skin (semiocclusive). The test item did not provoke any signs of oedema or erythema at any point of time.
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