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EC number: 217-168-8 | CAS number: 1761-71-3
- 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:
- 27.02.1991 to 22.03.1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4,4'-methylenebis(cyclohexylamine)
- EC Number:
- 217-168-8
- EC Name:
- 4,4'-methylenebis(cyclohexylamine)
- Cas Number:
- 1761-71-3
- Molecular formula:
- C13H26N2
- IUPAC Name:
- 4,4'-methylenedicyclohexanamine
- Test material form:
- other: liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
Strain: New Zealand White rabbit
Age at study initiation: twelve t o sixteen weeks
Sex: male and female
Weight at study initiation: 2.22 - 2.47 kg
Housing: individually in suspended metal cages
Diet(ad libitum):Spillers Rabbit Diet, Dalgety Agriculture Ltd., Almondsbury, Bristol
Water ad libitum
ENVIRONMENTAL CONDITIONS
Temperature: 18- 22 °C
Humidity: 50- 60 %
Air changes/ hour: 15
Photoperiod: 12 hours light/ 12 hours dark
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 3 minutes and approx 2.75 hours (4 hour exposure was terminated early)
- Observation period:
- 1 hour, 24 hours, 48 hours and 72 hours following removal of the test material after the 3 minute exposure.
1 hour following removal of the test material after the 2.75 hour exposure. - Number of animals:
- 6
- Details on study design:
- The study was performed to assess the irritancy potential of the test material following single, semi -occluded applications to the intact rabbit skin for exposure periods o f 2 3/4 hours and 3 minutes (Safepharm Standard Method Number OECD 4). The method used followed the recommendations of the OECD Guidelines for Testing of Chemicals (1981) No. 404 "Acute Dermal Irritation/Corrosion" referenced as Method B4 in Commission Directive 84/449/EEC (which constitutes Annex V o f Council Directive 67/548/EEC).
The results may be used as a basis for classification and labelling under Annex VI o f Council Directive 67/548/EEC (as adapted to technical progress by Commission Directive 83/467/EEC).
The test system was chosen because the rabbit has been shown to be a suitable model for this type of study and is recommended in the test method.
The results of the study are believed to be of value in predicting the likely skin irritancy potential of the test material to man.
Approximately twenty-four hours prior to the commencement of the test, each of a group of three rabbits was prepared by closely clipping the fur from the dorsal flank areas using veterinary clippers.
Only animals with a healthy intact epidermis by gross observation were selected for the study. On the day of the test a suitable testsite was selected on the back of each rabbit. A quantity of 0.5 ml of the test material was introduced under a 2.5 cm x 2.5 cm gauze patch and placed i n position on the shorn skin. The patch was secured in position with a strip of surgical adhesive tape (BLENDERM: approximate size 2.5 cm x 4.0 cm).
To prevent the animals from interfering with the patches the trunk of each rabbit was wrapped in an elasticated corset (TUBIGRIP) and the animals were returned to their cages for the duration of the exposure period.
Approximately 2 3/4 hours after application the corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton wool soaked in diethyl ether.
An additonal group of three rabbits was exposed to the test material underidentical conditions to the 2 3/4 hour exposure, except that the patches were removed three minutes after application to the skin. Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later (where appropriate), the test sites were examined for evidence of primary irritation and scored according to the following scale from Draize J.H. (1959).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 165 min
- Score:
- 6
- Max. score:
- 12
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Remarks:
- after 3 min exposure
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 10
- Max. score:
- 12
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Remarks:
- after 3 min exposure
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 6
- Max. score:
- 12
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Remarks:
- after 3 min exposure
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 12
- Max. score:
- 12
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Remarks:
- after 3 min exposure
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 11
- Max. score:
- 12
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Remarks:
- after 3 min exposure
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 10
- Max. score:
- 12
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Remarks:
- after 3 min exposure
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 12
- Max. score:
- 12
- Reversibility:
- not reversible
- Irritant / corrosive response data:
- 2.75 hour exposure -
Severe dermal necrosis, haemorrhage of the dermal capillaries and loss of skin elasticity were noted at all treated skin sites, one hour after patch removal. The reactions extended beyond the treatment site in two animals and an isolated incident of bleeding was also noted.
An accurate evaluation o f the degree of oedema was not possible due to the other adverse dermal reactions.
All animals were killed for humane reasons and in accordance with Home Office regulations following the one hour observation.
3 minute exposure -
Very slight to well-defined erythema and haemorrhage of the dermal capillaries were noted at all treatment sites one hour after patch removal and persisted at two sites at the 24-hour observation. Well-defined erythema was also noted at one treatment site at the 48- and 72-hour observations. A hardened dark brown/black coloured scab, surrounded by well-defined erythema and with light brown discolouration of the epidermis was also noted at the remaining treatment sites at these times. An accurate evaluation of erythema was not possible at the 48- and 72-hour observations due to the severity of the other dermal reactions.
Very slight oedema was noted at all treatment sites one hour aafter patch removal with moderate to severe oedema noted at all other observation times. Evaluation of oedema was commonly precluded by other adverse dermal reactions.
Green/brown coloured areas of possible dermal necrosis indicative of dermal corrosion were noted at one treated skin site at the 24- and 48-hour observations.
All animals were killed for humane reasons and in accordance with Home Office regulations after the 72-hour observation. - Other effects:
- not reported
Applicant's summary and conclusion
- Conclusions:
- The 3 minute exposure did not result in necrosis at the 1-hour observation period but one out of three animals exhibited necrosis at the 24-hour observation. The 2.75 hour exposure resulted in necrosis by the one hour post exposure observation. It was therefore determined that the test substance meets the criteria for classification as a Packing Group II, GHS 1B corrosive, and DSD R35 corrosive.
- Executive summary:
In an OECD Guideline 404 study, rabbits were dermally exposed to PACM to assess skin irritancy/corrosivity.
The test material was regarded as corrosive according to EEC labelling regulations.
The test material also produced a modified primary irritation index of 6.0 (based on values for erythema only).
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