Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 220-410-5 | CAS number: 2756-56-1
- 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:
- Apr 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- This information is used for read across to Isobornyl propionate.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- 4 chemicals were assessed simultaneously per animal, at distant and well defined sites
- Qualifier:
- according to guideline
- Guideline:
- other: methods for determination of toxicity (Annex V of the EEC Directive 79/831)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl acetate
- EC Number:
- 204-727-6
- EC Name:
- Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl acetate
- Cas Number:
- 125-12-2
- Molecular formula:
- C12H20O2
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: A. Smith, 7 Kydcomb Road, Warlingham, Surry
- Housing: Individual in aluminium cages with grid floors and no bedding material.
- Diet: Commercially available pelleted rabbit diet (product ref. 680, Dalgety-Spillers Limited)
- Water: Mains tap water was available at all times via automatic drinking nozzles in each cage
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 22
- Humidity (%): 42 to 65
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 168 hours (7 days)
- Number of animals:
- 4 females
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm square on the clipped dorsal skin
- Type of wrap: The test material was placed evenly over a square (2.5 cm) of surgical lint B.P. The lint square was then placed onto the animal’s skin. The lint patches were held in place by encircling the trunk of the animal with a length of ‘Elastoplast’ elastic adhesive bandage (10 cm wide)
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: The patch was removed after 4 hours.
- Washing: the treated sites were cleansed by gentle swabbing with cotton wool soaked in warm water.
OBSERVATION TIME POINTS
1, 24, 78 and 168 hours after removal of the test substance
SCORING SYSTEM
- Erythema and Eschar formation: 0 (no erythema); 1 (very slight erythema (barely perceptible); 2 (well-defined erythema); 3 (moderate to severe erythema); 4 (severe erythema (beet redness) to slight eschar formation (injuries in depth)
- Oedema formation: 0 (no oedema); 1 (very slight oedema (barely perceptible); 2 (slight oedema (edges of area well defined by definite raising); 3 (moderate oedema (raised approximately 1 mm); 4 (severe oedema (raised more than 1 mm and extending beyond area of exposure)
- Other signs of reaction to treatment such as corrosive action or systemic effects were fully described.
- Method of calculation: The numerical values or scores given to the erythema observed in each animal of the treated group at the twenty four, forty eight and seventy two hour examinations were summed. This total was then divided by three, the number of examinations that the figures were taken from, and further divided by the number of animals in the group. The value obtained on assessing oedematous reaction were similarly treated. The average scores obtained may be used in any subsequent classification of the material, a value of two or more for either erythema or oedema resulting in the material being regarded as irritant to the skin.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 168 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 168 hours
- Irritation parameter:
- edema score
- Basis:
- animal: #1 and #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 168 hours
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 168 hours
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 168 hours
- Irritant / corrosive response data:
- - One hour after dosing: well defined erythema and slight oedema were observed in two animals, well defined erythema and very slight oedema were observed in one animal and very slight erythema and oedema of the treated skin were noted in the remaining animal. The response of this animal slightly increased within 24 hours of dosing when well defined erythema and slight oedema were apparent. This reaction had reversed back to that previously described within 72 hours of dosing.
- 168 hours after dosing: Well defined erythema and very slight oedema of the skin were observed in two rabbits at the 168 hour observation, one other animal of the group exhibiting very slight erythema and oedema. - Other effects:
- - Other adverse local effects: At the 168 hour timepoint slight desquamation was observed in animal #1 and #2, desquamation was observed in animal #4. No such signs were apparent in animal #3.
Any other information on results incl. tables
Summary of data
|
Erythema |
edema |
|
||||||
Time |
Animal #1 |
Animal #2 |
Animal #3 |
Animal #4 |
Animal #1 |
Animal #2 |
Animal #3 |
Animal #4 |
Comments |
1 hour |
2 |
2 |
2 |
1 |
2 |
2 |
1 |
1 |
None |
24 hours |
2 |
2 |
2 |
2 |
2 |
2 |
1 |
2 |
None |
48 hours |
2 |
2 |
2 |
2 |
2 |
2 |
1 |
1 |
None |
72 hours |
2 |
2 |
2 |
1 |
2 |
2 |
1 |
1 |
None |
168 hours |
2 |
2 |
1 |
0 |
1 |
1 |
1 |
0 |
Slight desquamation in animals #1 and 2, desquamation in animal #4 |
|
|
|
|
|
|
|
|
|
|
Average/animal (1 and 168 hours not included) |
2 |
2 |
2 |
1.7 |
2 |
2 |
1 |
1.3 |
|
Average/overall |
1.9 |
1.6 |
|
Applicant's summary and conclusion
- Interpretation of results:
- other: Not a skin irritant
- Remarks:
- in accordance with EU CLP (EC No. 1272/2008 and its updates)
- Conclusions:
- Based on the mild irritating properties of the substance observed in the presented study in rabbit, the substance is not classified as irritating to the skin.
- Executive summary:
A GLP-compliant skin irritation study was performed similar to OECD TG 404. Four Female New Zealand White rabbits were treated with 0.5 mL unchanged test substance on the clipped dorsal skin (applied on 2.5 cm2surgical lint). The material was applied simultaneously with 3 other substances on distant sites. The material was held in contact with the skin using a semi-occlusive patch assembly for 4 hours after witch the patches were removed and the skin was cleaned with cotton wool soaked in warm water. Examinations for sign of reaction to the treatment were made after 1, 24, 48, 72 and 168 hours. One hour after dosing well defined erythema and slight edema were observed in two animals, well defined erythema and very slight edema were observed in one animal and very slight erythema and edema of the treated skin were noted in the remaining animal. The response of this animal slightly increased within 24 hours of dosing when well defined erythema and slight edema were apparent. This reaction had reversed back to that previously described within 72 hours of dosing. Well defined erythema and very slight edema of the skin were observed in two rabbits at the 168 hour observation, one other animal of the group exhibiting very slight erythema and edema. Desquamation from the skin surface was also observed in three rabbits. The average scores calculated from the numerical values given to the irritation observed at the 24, 48 and 72 hour observations were 1.9 for erythema and 1.6 for edema.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.