Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 218-487-5 | CAS number: 2162-74-5
- 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 / corrosion, other
- Remarks:
- in-vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1993-02-04 - 1993-04-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
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:
- other: EEC directive 84/449/EEC
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Bis(2,6-diisopropylphenyl)carbodiimide
- EC Number:
- 218-487-5
- EC Name:
- Bis(2,6-diisopropylphenyl)carbodiimide
- Cas Number:
- 2162-74-5
- Molecular formula:
- C25H34N2
- IUPAC Name:
- N,N'-bis[2,6-bis(propan-2-yl)phenyl]methanediimine
- Details on test material:
- - Name of test material: bis(2.6-diisopropylphenyl)carbodiimide
- Substance type: organic technical product
- Physical state: white powder
- Lot/batch no. MT92003
- Identification: labelled, where appropriate, with name of test article, batch no., name of sponsor, project no., date of receipt, storage conditions, handling precautions and expiration date
- Storage: ambient, protected from humidity
- Stability: 2 years
- Solvent/vehicle: none
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harald Schriever; Kaninchenfarm, Bremervörde, Neuendamm
- Animal selection: random
- Animal identification: with individual ear tags; cage labelled with ear tag no., sex, date of study initiation, project no.
- Housing: individual housing (50 x 45 x 40 cm, L x B x H) in a battery of cages, each equipped with a paper roll disposal system
- Diet (e.g. ad libitum): Ssniff K-Haltung (Ssniff Spezialdiäten GmbH, Soest/Westfalen, Germany)
- Water (e.g. ad libitum): ad libitum (half-yearly analyses and bacteriological tests)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3°C
- Humidity (%): 30 - 70 % (Measurement: with thermo hygrometer twice daily)
- Photoperiod (hrs dark / hrs light): artificial lighting (120 lux) from 7.00 a.m. - 7.00 p.m.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: fur was removed with electric clippers
- Vehicle:
- water
- Remarks:
- moistened sufficiently with aqua ad injectabilia to ensure good contact with the skin
- Controls:
- other: an adjacent area of untreated skin served as control
- Amount / concentration applied:
- 0.5 g on about 6 cm² in size
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 30-60 min, 24, 48 and 72 h after patch removal.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: roughly 8 x 15 cm on the back of each animal
- % coverage:
- Type of wrap if used: each test area was covered with a semi-occlusive dressing consisting of Ypsiplast® (Holthaus Medical, Remscheid-Lüttringhausen), which was held in place by non-irritating tape Elastoplast® (Beiersdorf AG, Hamburg), and Stülpa® (P. Hartmann AG, Heidenheim-Brenz), which enveloped the whole of the animal's trunk.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the 4-h exposure period, the dressing was removed and any residual sample was carefully washed off with water or an appropriate solvent.
- Time after start of exposure: 4 hours
24 h before treatment, fur was removed with electric clippers from an area of roughly 8 x 15 cm on the back of each animal. The skin was examined for abrasions and only animals with healthy, intact skin were used in the test.
The solid test article was moistened sufficiently with Aqua ad injectabilia to ensure a good contact with the skin.
In each animal, 0.5 g of the test article were applied to the test site (ca. 6 cm² in size), an adjacent area of untreated skin serving as a control.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 30-60 minutes and 24; 48; 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 30-60 min and 24; 48; 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- No test article-dependent findings were observed. No toxic effects were observed.
- Other effects:
- No other effects reported
Any other information on results incl. tables
Table 1: individual detailed data
|
Time after patch removal |
|||||||||||||||
Animal number |
30-60 min |
24 h |
48 h |
72 h |
||||||||||||
|
Ery |
Oed |
Ery |
Oed |
Ery |
Oed |
Ery |
Oed |
||||||||
|
T |
C |
T |
C |
T |
C |
T |
C |
T |
C |
T |
C |
T |
C |
T |
C |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
T= test site,
C= control site,
Ery = erythema,
Oed = oedema.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EU-GHS
- Conclusions:
- The study was performed according to the OECD Guideline 404 with no deviations and according to the good laboratory practice principles, it is considered to be of the highest quality (reliability Klimisch 1). The criteria of validity of the test system are fulfilled. The mean grades of skin reactions at 24, 48 and 72 h after patch removal were lower than the value classified as irritant by the European regulation (EC) No. 1272/2008, amending regulation EC no. 1907/2006 (REACh). When applied to the skin, the test article may therefore be considered to be non-irritant. The test material did not induce irritation on the intact skin of rabbits. The product bis(2.6-diisopropylphenyl)carbodiimide is considered to be not irritating to the skin.
- Executive summary:
The skin irritation potential of the test substance was investigated in rabbits (Kaufmann, 1993, according to TG OECD 404). Bis(2.6-diisopropylphenyl)carbodiimide was applied to the skin of rabbit (skin prepared with electric clippers, 0.5 mg pure substance moistened with water) for 4 hours under semiocclusive conditions. The study was performed according to the OECD Guideline 404 with no deviations and according to the good laboratory practice principles, it is considered to be of the highest quality (reliability Klimisch 1). The criteria of validity of the test system are fulfilled. After this period the skin was evaluated 30- 60 min, 24, 48 and 72 h after patch removal. No test article- dependent findings were observed. The mean grades of skin reactions were lower than the value classified as irritant by the European regulation (EC) No. 1272/2008, amending regulation EC no. 1907/2006 (REACh). When applied to the skin, the test article may therefore be considered to be non- irritant.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.