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EC number: 215-833-7 | CAS number: 1423-46-7
- 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:
- The study was conducted in 1984.
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Animals are not observed during 14 days
- Principles of method if other than guideline:
- Primary irritation to the skin is measured by a patch-test technique on the clipped dorsum of albino rabbits under semi-occlusive conditions.
- GLP compliance:
- no
- Remarks:
- The study pre-dates GLP.
Test material
- Reference substance name:
- Isocyclocitral - PM 896
- IUPAC Name:
- Isocyclocitral - PM 896
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material: Isocyclocitral
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- The rabbits are housed individually in suspended cages with wire mesh floors. They have free acces to tap water and pelleted rabbit diet with vitamin and mineral suppléments.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 0.5 mL undiluated
- Duration of treatment / exposure:
- Patches applied for 4 hours.
- Observation period:
- assessments after 4, 24, 48 and 72 hours
- Number of animals:
- 8 rabbits for test
- Details on study design:
- Protocol for Rabbit Single Application Covered Patch Skin Irritation Test.
The following is an outline description of how to carry out this skin irritation test. The precise details of how to carry out each operation are described in the skin irritaiton Standard Operation procedure SOP 12 held in the skin irritation area.
Experimental design - The test is designed to investigate the irritant effects of a single application of substance to skin under semi-occlusive conditions which enhance penetration and interaction of the test materials and the skin. The irritancy of test substances is normally compared with that of standard substances applied in the same way.
Animals - Eight healthy adult New Zealand White, brought from a commercial supplier, are used for testing when the hair is in a non-growth (telogen) phase of the hair cycle. Three to 4 days prior to testing the backs and flanks of 9 to 12 week old rabbits are clipped to identify those which are in telogen and which have no skin blemishes. Of these rabbits, 8 are selected for the test. The hair is given a final clip approximately 2 hours prior to treatment.
Patches - Each patch consists of a 25 x 25 mm, 16-ply gauze pad backed by a 20 x 20 mm strips of thin polythene and stuck to a 25 x 75 mm strip of zinc oxide plaster.
Treatment - Each substance is applied to every rabbit in the test: up to 6 patches can be applied to each rabbit. Prior to treatment a plan (based on random number sequences) is prepared of application sites of each substance on each rabbit. The concentration and quantities of substances and the nature of the application is specified in the protocol summary, and is detailed in the summary page and in table 1 of the report. When all patches have been applied to a rabbit it is immobilised in a canvas body sleeve and placed in a quiet place for the 4 hour aplication period, at the end , of which the animals are removed from the body sleeves and the corners of each treatment site marked. The patches are then removed and excess substance wiped from the skin with a damp tissue.
Assessment of Irritiation - The skin treatment sites are assessed for irritation immediately after removal of the patches and at 24, 48 and 72 hours after treatment. Each animal is scored blind; the scores are not linked to the substances tested until all assessments in the test have been carried out. Reactions are assessed for erythema, oedema, cracking and scaling on a 9-point scale ranging from very slight (a) to severe (h). Any other features of the responses are described and recorded as a fraction of treated area.
Evaluation of skin irritation Scores:
0 - Normal Skin
1 - Marginal - Slight erythema and oedema (grade a) at 24 hours but no effects observed at 72 hours.
2 - Slight - Slight erythema and oedema (grades up to bbbb) at 24 hours.
3 - Slight/Moderate - Slight/moderate erythema and oedema (grades ca-cc) at 24 hours. The reaction generally reduces to slight at 72 hours but sometimes the slight/moderate reaction may be maintained.
4 - Moderate - Moderate erythema and oedema (grades c and d) with slight cracking and scaling at 24 hours with the erytheme and oedema being maintained at least slight/moderate level with cracking and scaling developing at 72 hours.
5 - Strong - As for 4 above or greater erythema and oedema with evidence of up to 1/4 of the site affected by necrosis.
6 - Severe - Most of site affected by suspected necrosis.
7 - Extreme - Deep necrosis over whole site identified by depressed, hard scab/tissue and surrounding inflammatory reaction.
Summary and Analysis of Macroscopic Results:
At the end of the test the irritation reaction produced by each test material at 24 and 72 hours after treatment is assigned a single overall irritation score which is recorded along with the irritation scores on Table III a, b, et seq. (For full details of overall irritation scores see Appendix 1). The overall irritation scores for all treatment sites per group and the total irritation score per group are recorded in Table II (a).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- animal #1
- Time point:
- other: 4/24/48/72 hours
- Score:
- 3
- Max. score:
- 7
- Reversibility:
- not fully reversible within: 72 hours.
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- overall irritation score
- Basis:
- animal #2
- Time point:
- other: 4/24/48/72 hours
- Score:
- 6
- Max. score:
- 7
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- overall irritation score
- Basis:
- animal #3
- Time point:
- other: 4/24/48/72 hours
- Score:
- 6
- Max. score:
- 7
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- overall irritation score
- Basis:
- animal #4
- Time point:
- other: 4/24/48/72 hours
- Score:
- 4
- Max. score:
- 7
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- overall irritation score
- Basis:
- animal #5
- Time point:
- other: 4/24/48/72 hours
- Score:
- 6
- Max. score:
- 7
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- overall irritation score
- Basis:
- animal #6
- Time point:
- other: 4/24/48/72 hours
- Score:
- 4
- Max. score:
- 7
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- overall irritation score
- Basis:
- animal: #7
- Time point:
- other: 4/24/48/72 hours
- Score:
- 3
- Max. score:
- 7
- Reversibility:
- not fully reversible within: 72 hours.
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- overall irritation score
- Basis:
- animal: #8
- Time point:
- other: 4/24/48/72 hours
- Score:
- 3
- Max. score:
- 7
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.6
- Max. score:
- 8
- Reversibility:
- not fully reversible within: 72h
- Remarks on result:
- other: the result is done by overall irritation score
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3.3
- Max. score:
- 8
- Reversibility:
- not fully reversible within: 72h
- Remarks on result:
- other: the result is done by overall irritation score
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3.3
- Max. score:
- 8
- Reversibility:
- not fully reversible within: 72h
- Remarks on result:
- other: the result is done by overall irritation score
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 3.6
- Max. score:
- 8
- Reversibility:
- not fully reversible within: 72h
- Remarks on result:
- other: the result is done by overall irritation score
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 8
- Reversibility:
- not fully reversible within: 72h
- Remarks on result:
- other: the result is done by overall irritation score
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 3.3
- Max. score:
- 8
- Reversibility:
- not fully reversible within: 72h
- Remarks on result:
- other: the result is done by overall irritation score
- Irritation parameter:
- erythema score
- Basis:
- animal: #7
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 8
- Reversibility:
- not fully reversible within: 72h
- Remarks on result:
- other: the result is done by overall irritation score
- Irritation parameter:
- erythema score
- Basis:
- animal: #8
- Time point:
- 24/48/72 h
- Score:
- 2.6
- Max. score:
- 8
- Reversibility:
- not fully reversible within: 72h
- Remarks on result:
- other: the result is done by overall irritation score
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 8
- Reversibility:
- not fully reversible within: 72h
- Remarks on result:
- other: the result is done by overall irritation score
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 8
- Reversibility:
- not fully reversible within: 72h
- Remarks on result:
- other: the result is done by overall irritation score
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 8
- Reversibility:
- not fully reversible within: 72h
- Remarks on result:
- other: the result is done by overall irritation score
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 8
- Reversibility:
- not fully reversible within: 72h
- Remarks on result:
- other: the result is done by overall irritation score
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 8
- Reversibility:
- not fully reversible within: 72h
- Remarks on result:
- other: the result is done by overall irritation score
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 8
- Reversibility:
- not fully reversible within: 72h
- Remarks on result:
- other: the result is done by overall irritation score
- Irritation parameter:
- edema score
- Basis:
- animal: #7
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 8
- Reversibility:
- not fully reversible within: 72h
- Remarks on result:
- other: the result is done by overall irritation score
- Irritation parameter:
- edema score
- Basis:
- animal: #8
- Time point:
- 24/48/72 h
- Score:
- 1.6
- Max. score:
- 8
- Reversibility:
- not fully reversible within: 72h
- Remarks on result:
- other: the result is done by overall irritation score
- Irritant / corrosive response data:
- Isocyclocitral - PM 896 showed slight/moderate effects with one animal showing pale brown tissue 24 hours after treatment. By 72 hours showed a variable slight/moderate to moderate response with three animals showing brown tissue. This response is very similar to the control Geraniol. The control Diethyl Phthalate showed the least effects with a minimal response 24 hours after treatment and no effects 72 hours after treatment.
Any other information on results incl. tables
In the study the scale for the evaluation of erythema and oedema is:
-: no reaction
a: marginal (very slight)
b: slight
c: fairly distinct
d: quite distinct
e: becoming well developed
f: well develiped
g: becoming severe
h: severe
For the IUCLID completion need this scale has been transposed into numerical values (0= no reaction, 8=severe
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Isocyclocitral - PM 896 is slight/moderately irritant with evidence of necrosis. This response is similar to the control Geraniol. The control Diethyl Phthalate shows the least effects and is virtually non-ittitant.
- Executive summary:
Isocyclocitral - PM 896 is slight/moderately irritant with evidence of necrosis. This response is similar to the control Geraniol. The control Diethyl Phthalate shows the least effects and is virtually non-irritant.
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