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EC number: 260-280-7 | CAS number: 56602-77-8
- 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
Endpoint summary
Administrative data
Description of key information
Skin
Corrosive (Category 1C), (Rabbit), OECD 404, Rees, P. B. (1991).
Eye
Data requirement waived on the basis the substance is corrosive.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06 December 1990 - 09 May 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was designed to meet the requirements of Section 4, of the OECD TG 404 (1981) and is in compliance with GLP; on this basis the study is considered reliable without restriction.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
- 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: 3 - 3.5 months
- Weight at study initiation: 2.63 - 2.76 kg
- Housing: individually in suspended stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15-23
- Humidity (%): 40-70
- Air changes (per hr): 15 complete air changes per hour without re-circulation
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 4 December 1990 To: 7 December 1990 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1 hour, 24, 48 and 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 3 x 2 cm
- Type of wrap if used: gauze patch held in place on the left test site by strips of Blenderm (3-M Company)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): where necessary, the treatment sites were gently washed with warm water
- Time after start of exposure: 72 hours
SCORING SYSTEM: Refer to tables under "Any other information on materials and methods incl. tables" - Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.66
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal: #1 and #3
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Remarks:
- Due to the brown colouration no erythema was visible. The brown colouration became black with a necrotic appearance.
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- Animal #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Brown colouration, loss of flexibility and/or moderate erythema were observed in two animals (animal#1 and animal#3) within one hour of removal of the bandages. The brown colouration darkened, obscuring any possible erythema at either test site , and became black with a necrotic appearance at the 48 and 72 hour examinations.
The animal#2 showed well-defined or moderate erythema around the edges of the test site throughout the observation period. A brown or black necrotic appearance, loss of flexibility and sensitivity to touch were observed during this period. At the 72 hour assessment, a wound, exposing the subcutis, was evident at the base of the test site. - Interpretation of results:
- Category 1C (corrosive)
- Conclusions:
- Under the conditions of this test, NBDA is classified as a corrosive according to the Classification, Labelling and Packaging Regulation (classification: Category 1 : Corrosive 1C; Hazard statement: H314 "Causes severe skin burns and eye damage").
- Executive summary:
The potential of 2,5(and 6)-bis(aminomethy1)-bicyclo[2.2.1]-heptane, hereafter referred to as NBDA, to cause inflammatory or corrosive changes upon first contact with skin was assessed by semi-occluded application of 0,5 mL of the test material to the closely-clipped dorsa of three New Zealand White rabbits for four hours. Dermal reactions were assessed 1, 24, 48 and 72 hours after removal of the dressings.
Brown colouration and loss of flexibility were observed in two animals within one hour of removal of the dressings. The colouration darkened, obscuring any possible erythema at either test site and became black with a necrotic appearance at the 48 and 72 hour assessments.
The remaining animal showed a brown or black necrotic appearance to the test site, loss of flexibility and sensitivity to touch throughout the observation period. Well-defined or moderate erythema was observed around the edges. At the 72 hour assessment, a wound was evident at the base of the test site.
Due to the severity of the responses, all three animals were sacrificed after the 72 hour examination.
Under the conditions of this test, NBDA was classified as corrosive to skin according to the Classification, Labelling and Packaging Regulation (classification: Category 1 : Corrosive 1C; Hazard statement: H314 "Causes severe skin burns and eye damage").
Reference
As the all three animals after exposure of 4 hours produced visible necrosis which manifested at 48 hours after removal of dressings, NBDA is classified as a corrosive according to the Classification, Labelling and Packaging Regulation (classification: Category 1 : Corrosive 1C; Hazard statement: H314 "Causes severe skin burns and eye damage").
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study need not be conducted because the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
In accordance with Column 2 of REACH Annex VIII, information requirement 8.5, this study does not need to be conducted because the substance is classified for skin corrosion.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin
In the key study, the potential of the test material to cause inflammatory or corrosive changes upon first contact with skin was assessed in a study which was conducted under GLP conditions and in accordance with the standardised guideline OECD 404.
During the study, 0.5 mL of the test material was applied under semi-occlusion to the closely-clipped dorsa of three New Zealand White rabbits for four hours. Dermal reactions were assessed 1, 24, 48 and 72 hours after removal of the dressings.
Brown colouration and loss of flexibility were observed in two animals within one hour of removal of the dressings. The colouration darkened, obscuring any possible erythema at either test site and became black with a necrotic appearance at the 48 and 72 hour assessments.
The remaining animal showed a brown or black necrotic appearance to the test site, loss of flexibility and sensitivity to touch throughout the observation period. Well-defined or moderate erythema was observed around the edges. At the 72 hour assessment, a wound was evident at the base of the test site.
Due to the severity of the responses, all three animals were sacrificed after the 72 hour examination.
Under the conditions of this test, the substance was classified as corrosive to skin according to the Classification, Labelling and Packaging Regulation (classification: Category 1 : Corrosive 1C; Hazard statement: H314 "Causes severe skin burns and eye damage").
Supporting information is available in the form of a study, conducted in line with the method described in Code of Federal Regulations, Title 16, Section 1500.41.
During the study three rabbits were each administered a dermal dose of 0.5 mL of the test substance to one intact and one abraded skin site and observed for three days. A single occlusive application of the test material to intact and abraded rabbit skin for twenty-four hours elicited severe dermal reactions with necrosis observed at all intact and abraded skin sites. The Primary Irritation Index (PII) was estimated to be 8.0 and the substance is therefore classified as a severe irritant.
Eye
In accordance with Column 2 of REACH Annex VIII, information requirement 8.5, this study does not need to be conducted because the substance is classified as skin corrosion.
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No. 1272/2008, the substance requires classification with respect to the skin as Corrosive, Category 1C (H314: Causes severe skin burns and eye damage) and with respect to the eye as Category 1 (H318: Causes serious eye damage).
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