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EC number: 906-078-0 | CAS number: -
- 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
Dermal:
As part of a "Weight of Evidence Approach", three studies were assessed. A modified Draize sensitization study where a preliminary irritation screen was conducted to determine the application challenge concentration (100%). A dermal acute LD50 study dosed at 5 mL/kg and a human irritiation experiment at 2%. No irritation was noted in any of the three studies indicatin no irritation risk when exposed to geranyl formate.
Eye:
The slight irritation noted was only slightly more than for the vehicle control ( alcohol SDA 39C) and not sufficient for classification purposes.
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:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Qualifier:
- according to guideline
- Guideline:
- other: Maximization Test (J.I.D; Vol. 47; #5; 1966)
- GLP compliance:
- no
- Remarks:
- study pre-dates GLP introducion
- Specific details on test material used for the study:
- Geranyl Formate
- Species:
- human
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- other: petrolatum N.F
- Duration of treatment / exposure:
- Each material was applied to the same skin site for five alternate-day fourty-eight hour periods under occlusion. Following a 10-day rest period, occlusive challenge patches were applied to fresh skin sites for fourty-eight hours. Challenges were evaluated at 48 and 72 hours.
- Number of animals:
- Twenty-five healthy adult males
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Geranyl Formate did not produce any cases of contact allergy or irritation.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Qualifier:
- no guideline available
- GLP compliance:
- no
- Remarks:
- study pre-dates GLP introduction
- Specific details on test material used for the study:
- CFI-70 Geranyl Formate
Colourless liquid - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- New Zealand WHite rabbits of both sexes (weighing 2.5 to 3.0 kg) were used. All animals were individually housd, commercial diets were offered, and water was available ad libitum.
- Preparation of test site:
- other: An area measuring approximately 240 cm2 was clipped, and the site was abraded on 2 animals while the site on the remaining 2 animals remained intact. The test site was slightly moistened with physiological saline prior to application.
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 5 ml/kg of neat test material
- Observation period:
- The animals were observed for irritation daily for 14 days
- Number of animals:
- Four rabbits of both sexes
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No skin irritation was observed following treatment of Geranyl Formate of New Zealand White rabbits.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- Performed equivalent to OECD 406 guideline.
- GLP compliance:
- no
- Remarks:
- study pre-dates GLP introduction
- Specific details on test material used for the study:
- Perfume ingredient: Geranyl Formate
- Species:
- guinea pig
- Strain:
- Hartley
- Details on test animals or test system and environmental conditions:
- Sensitization tests were carried out on inbred Hartley strain albino guinea pigs bred in our own colony. During testing they were housed in wire mesh cages in pairs of the same sex and were fed pelleted guinea pig diet, cabbage, hay and water ad libitum. Ten animals weighing about 350 g at the start of testing were used in each test which comprised either 4 males and 6 females or visa versa. For demonstration of sensitivity by challenge with the test substance the hair was shaved from both flanks with Oster animal clippers, size 40 blades, and the test substance injected intradermally into one flank and applied topically without occlusion to the other flank.
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Number of animals:
- 10 animals
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- An application of Geranyl Formate was not found to be irritating to the skin of guinea pigs.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 1972
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
- Remarks:
- study pre-dates introduction of GLP
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Nerger Formate
- Lot: SA-08-1712 - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.3 to 3.4 kg
- Housing: Individually housed
- Diet: Free access to commercial diets
- Water: Free access to water - Vehicle:
- other: alcohol SDA 39C
- Controls:
- other: the other eye, remaining untreated, served as control.
- Amount / concentration applied:
- Each animal had 0.1ml of the test sample instilled into the right eye with no further treatment
- Observation period (in vivo):
- 1, 4, 24, 48, 72 and 96 hours and daily thereafter for a total of seven days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no
SCORING SYSTEM: Draize method
TOOL USED TO ASSESS SCORE: At day 7, all eyes were re-examined with the aid of fluorescein ophthalmic solution. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 0
- Remarks on result:
- other: no effects were observed
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 0
- Remarks on result:
- other: no effects were observed
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 0
- Remarks on result:
- other: no effects were observed
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: no individual Draize scores were reported
- Irritant / corrosive response data:
- No lesions occurred in the cornea and iris in the animals at any time following the instillation of the test substance. Conjunctival irritation was observed at one and four hours in four out of six animals and in one animal at 24 hours. The effects were fully reversible within 72 hours.
- Other effects:
- No systemic toxic effects occurred.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an eye irritation study with rabbits, performed equivalent to OECD 405 test guideline, limited irritation was observed.
- Executive summary:
The test substance Geranyl Formate was tested in an acute eye irritation study with rabbits, performed equivalent to OECD 405 guideline. No systemic toxic effects occurred. No lesions occurred in the cornea and iris in the animals at any time following the instillation of the test substance. Conjunctival irritation was observed at one and four hours in four out of six animals and in one animal at 24 hours. The effects were fully reversible within 72 hours. Based on the results, Geranyl Formate does not have to be classified for eye irritation according to Regulation (EC) No 1272/2008.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
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.
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