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Diss Factsheets
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EC number: - | 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:
- From 1991-08-06 to 1991-08-09
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP study in accordance with recognised test guideline but: Lot/batch No.: not stated Expiration date of the lot/batch: not stated NOTE: study deemed acceptable because spectral data for test item are available, covering approximately before and after the test period - see section 1.4 Analytical Information.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Details on test material:
- - Name of test material (as cited in study report): Di Urea Compound A-3622
- Molecular formula (if other than submission substance): N/A
- Molecular weight (if other than submission substance): N/A
- Smiles notation (if other than submission substance): N/A
- InChl (if other than submission substance): N/A
- Structural formula attached as image file (if other than submission substance): N/A
- Substance type: Organic
- Physical state: Fine, of white powder
- Analytical purity: Approximately 100%
- Impurities (identity and concentrations): Not reported
- Composition of test material, percentage of components: not reported
- Isomers composition: Not reported
- Purity test date: Not reported
- Lot/batch No.: Not reported
- Expiration date of the lot/batch: Not reported
- Stability under test conditions: Not reported
- Storage condition of test material: ambient temperature
- Other: N/A
Constituent 1
- Specific details on test material used for the study:
- - Substance type: Organic
- Physical state: Fine, off-white powder
- Analytical purity: Approximately 100%
- Storage condition of test material: ambient temperature
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ranch Rabbits, Crawley Down, Sussex, England
- Age at study initiation: approximately three months
- Weight at study initiation: 2.52-2.82 kg
- Housing: They were individually housed in suspended stainless steel cages (Type RC10/L) mounted in mobile batteries (Modular Systems and Development Company Limited, London, England). The cages measured 61 x 76 x 46 cm high and were fitted with perforated counter-sunk floor panels. A tray beneath the floor was lined with absorbent crepe paper which was changed regularly.
- Diet (e.g. ad libitum): free access to a commercially available standard pelleted rabbit diet (S.Q.C.Rabbit Diet, Special Diet Services Limited, Witham, Essex, England). The diet contained no added antibiotic or other chemotherapeutic or prophylactic treatment.
- Water (e.g. ad libitum): free access to tap water. The water was taken from the public supply; in England the supply and quality of this water is governed by Department of the Environment regulations. There was no information indicating that normal levels of common contaminants would influence the outcome of the study.
- Acclimation period: An acclimatisation period of seven days was allowed between arrival at the laboratory and administration of the test material.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18°C (range 15°-23°C)
- Humidity (%): 55% R.H. (range 40%-70% R.H.)
- Air changes (per hr): 15 complete air changes per hour without re-circulation.
- Photoperiod (hrs dark / hrs light): lighting cycle of 12 hours of artificial light per day.
IN-LIFE DATES: From: 6 August 2009 To: 9 August 2009
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: the dorsum between the limb (6 x 6 cm) girdles
- Type of wrap if used: A single dose (0.5 g) was applied directly to the skin and covered by an unmedicated gauze patch (3 x 2 cm) which was held in place on the left test site by strips of Blenderm (3-M Company). The right test site, acting as a control, was covered by a similar semi-occlusive dressing but otherwise remained untreated. Pads of cotton wool and elasticated bandage were used to protect the patches and ensure good contact between the skin and the test material during the four-hour exposure period. The elasticated bandage was held in place by thin strips of waterproof plaster ('Sleek' - T &J Smith and Nephew Limited) at both edges.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treatment sites were then gently washed with warm water and dried with paper towels to remove excess test material adhering to the skin.
- Time after start of exposure: 4 hours
SCORING SYSTEM:
DRAIZE, JH (1959). In "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" p.47. Association of Food and Drug Officials of
the United States, Austin, Texas.
Actual criteria for assessment of skin irritation responses are given in Attached Background Information.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- No dermal response was observed at the test site of any animal at any time during the 72 hour observation period. The control sites did not show any response to the control procedure.
Any other information on results incl. tables
TABLE 1: Mean values for erythema and oedema 24, 48 and 72 hours after treatment
Animal number |
Erythema
|
Oedema |
||
Test |
Control |
Test |
Control |
|
91 1435M 91 1438M 91 1442M |
0.0 0.0 0.0 |
0.0 0.0 0.0 |
0.0 0.0 0.0 |
0.0 0.0 0.0 |
Scoring of irritance responses
Animal Number |
Type |
Score after removal of dressings |
||||||||
1 hour |
24 hour |
48 hour |
72 hours |
|||||||
Test site |
Control |
Test site |
Control |
Test site |
Control |
Test site |
Control |
|||
91 1435M |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
91 1438M |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
91 1442M |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritanting
- Conclusions:
- Under the conditions of this test, the test item was classified as 'non-irritant' to the skin.
- Executive summary:
The potential of test item to cause inflammatory or corrosive changes upon first contact with skin was assessed by semi-occluded application of 0.5 g of the test material to the closely-clipped dorsa of three New Zealand White rabbits for four hours based on OECD 404.
Dermal reactions were assessed 1, 24, 48 and 72 hours after removal of the dressings. No dermal response was observed at the test site of any animal at any time during the 72 hour observation period. Under the conditions of this test, the test item was classified as 'non-irritant' to the skin.
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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