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EC number: 401-610-3 | CAS number: 122012-52-6 GENIPLEX A
- 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:
- until 1986-01-02
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- with sufficient documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- OECD Guideline for Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion".
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- Annex V E.E.C. directive 79/831/EEC. Part B: Methods for the determination of toxicity. B4. Skin irritation
- Deviations:
- not specified
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Diamminediisocyanatozinc
- EC Number:
- 401-610-3
- EC Name:
- Diamminediisocyanatozinc
- Cas Number:
- 122012-52-6
- Molecular formula:
- C2H6N4O2Zn
- IUPAC Name:
- copper(2+) bis(carbonylazanide) diamine
- Test material form:
- solid: particulate/powder
- Remarks:
- white powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Froxfield Rabbits, Petersfield, Hampshire
- Age at study initiation: 9 to 12 weeks
- Weight at study initiation: 2.0 to 2.7 kg
- Housing: The rabbits were individually housed in metal cages with perforated floors.
- Diet (e.g. ad libitum): SDS Standard Rabbit Diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: The rabbits selected for the study were all acclimated to the laboratory environment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Animal room temperature was maintained at approximately 19°C
- Humidity (%): Relative humidity was maintained at 30-70%.
- Air changes (per hr): Air exchange was maintained at approximately 19 air changes per hour.
- Photoperiod (hrs dark / hrs light): Lighting was controlled by means of a time switch to give 12 hours of artificial light (0700-1900 hours) in each 24 hour period.
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 (volume or weight with unit): 0.5 g
- Concentration (if solution): neat - Duration of treatment / exposure:
- 4 h
- Observation period:
- Examination of the treated skin was made on Day 1 (i.e. approximately 30 minutes after removal of the patches) and on Days 2, 3 and 4.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: Approximately 24 hours prior to application of the test substance, hair was removed with electric clippers from the dorso-lumbar region of each rabbit exposing an area of skin approximately 10 cm square.
A 0.5 g amount of the test item was applied under a 2.5 cm square gauze pad to one intact skin site on each animal.
- Type of wrap if used: 2.5 cm square gauze pad; Each treatment site was occluded with "Elastoplast" elastic adhesive dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period, the semi-occlusive dressing and gauze pad were removed and the treatment site was washed using distilled water to remove any residual test substance.
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
Examination of the treated skin was made on Day 1 (i.e. approximately 30 minutes after removal of the patches) and on Days 2, 3 and 4.
SCORING SYSTEM: according to the guideline, i.e.
Grading and scoring of the dermal reactions were performed using the prescribed numerical scoring system as follows:
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 millimeter) 3
Severe oedema (raised more than 1 millimeter and extending beyond the area of exposure) 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- None of the animals showed any observable response to treatment throughout the observation period.
Any other information on results incl. tables
Dermal reactions elicited by the test item
Rabbit Number and Sex |
E = Erythema 0 = Oedema |
Day |
|||
1* |
2 |
3 |
4 |
||
439M |
E 0 |
0 0 |
0 0 |
0 0 |
0 0 |
440F |
E 0 |
0 0 |
0 0 |
0 0 |
0 0 |
441M |
E 0 |
0 0 |
0 0 |
0 0 |
0 0 |
*Approximately 30 minutes after removal of the dressing M = Male F = Female
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Given data allows the conclusion that the test was well performed acc. OECD TG 404 and that the results are reliable. The scoring data was gained according to OECD TG 404, which allows a proper classification. Both edema and erythema scores were in all three animal zero, so classification as skin irritant is not required under GHS.
- Executive summary:
The study was performed acc. OECD TG 404 on 3 New Zealand white rabbits. 0.5 g of the test item was applied neat for 4 h under a semi-occlusive coverage on the clipped skin. After washing, scoring was performed as inidcated in the guideline. Application of the test item to rabbit skin for four hours under a semi- occlusive patch produced no observable skin irritation. Both edema and erythema scores were in all three animal zero, so classification as skin irritant is not required under Regulation 1272/2008.
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