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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 606-948-7 | CAS number: 2217-02-9
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 January 1991 - 17 January 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 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- other: micronucleus assay
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
- IUPAC Name:
- (1S,2S,4S) 1,7,7-trimethylbicyclo[2.2.1]hept-2-yl acetate
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG, Kastengrund, SPF breeding colony
- Age at study initiation: 7 weeks
- Weight at study initiation: 28.7 g (males) and 22.8 g (females)
- Housing: in fully air-conditioned rooms in Macrolon cages (Type 3), on softwood granulate in groups of 5 animals
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 55 ± 10 %
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: sesame oil
- Concentration of test material in vehicle: 20 % (w/v)
- Amount of vehicle (if gavage or dermal): 10 mL/kg bw - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
The test sample dilutions were prepared fresh each day. 500 mg test item were weight in a 25 mL flask, mixed with sesame oil and topped up to the calibration mark. - Frequency of treatment:
- Once
- Post exposure period:
- 24, 48 and 72 hours (killing times)
Doses / concentrations
- Dose / conc.:
- 2 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 70 animals (35 male and 35 female):
Group 1: 0 mg/kg bw (5 males and 5 females) killing time: 24 h post administration
Group 2: 2000 mg/kg bw (5 males and 5 females) killing time: 24 h post administration
Group 4: 0 mg/kg bw (5 males and 5 females) killing time: 48 h post administration
Group 5: 2000 mg/kg bw (5 males and 5 females) killing time: 48 h post administration
Group 6: 0 mg/kg bw (5 males and 5 females) killing time: 72 h post administration
Group 7: 2000 mg/kg bw (5 males and 5 females) killing time: 72 h post administration - Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Endoxan(R). Group 3 (5 males and 5 females) killing time: 24 h post administration
- Route of administration: oral, gavage
- Doses / concentrations: 50 mg/kg bw (0.5% w/v in distilled water , 10 mL/kg bw)
Examinations
- Tissues and cell types examined:
- Bone marrow erythrocytes cells (from both femora)
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
Preliminary studies were conducted to determine the highest administrable non lethal dose level. 3 mice per sex and per dose were exposed to 5000, 4000, 3000 and 2000 mg/kg bw test item.
TREATMENT AND SAMPLING:
After treatment, animals were killed by carbon dioxide asphyxiation 24, 48 and 72 hours after application.
For each animal, about 3 mL foetal bovine serum was poured into a centrifuge tube. Both femora were removed and the bones freed of muscle tissue. The proximal ends of the femora were opened and the bone marrow flushed into the centrifuge tube. A suspension was formed. The mixture was then centrifuged (5 min, 1200 rpm) and almost all the supernatant discarded. One drop of the thoroughly mixed sediment was smeared on a cleaned slide and air-dried for 24 hours. The slides were then stained.
METHOD OF ANALYSIS:
1000 polychromatic erythrocytes were counted for each animal. The number of cells with micronuclei was recorded. As a control measure 1000 mature erythrocytes were also counted and examined for micronuclei. The ratio of polychromatic to normochromatic erythrocytes (PCE/NCE) was determined. - Statistics:
- The number of polychromatic erythrocytes with micronuclei and the number of normocytes with micronuclei were evaluated statistically. The comparison of dose groups with the simultaneous control group was performed according to Wilcoxon (paired, one-sided, increase). The results of the treatment groups were compared with the corresponding control values. The ratio of polychromatic to normochromatic erythrocytes was also evaluated statistically by the method of Wilcoxon (paired, two sided). All statistical results were based on a 95% level of significance.
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- (see below)
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range: 5000, 4000, 3000 and 2000 mg/kg
- Mortality:
At 5000 mg/kg bw: 1/3 males and 2/3 females died;
At 4000 mg/kg bw: 0/3 males and 1/3 females died;
At 3000 mg/kg bw: 0/3 males and 3/3 females died;
At 2000 mg/kg bw: No death were observed.
- Clinical signs of toxicity in test animals: Several clinical signs were observed at 3000-5000 mg/kg bw doses. At 2000 mg/kg bw, uncoordinated gait, increased spontaneous activity and stilted gait was observed.
RESULTS OF DEFINITIVE STUDY
- Mortality: All animals survived.
- Signs of toxicity: uncoordinated gait, increased spontaneous activity. These signs were fully reversible by 5-6 hours after application.
- Induction of micronuclei (for Micronucleus assay): The number of polychromatic (PCE) and normochromatic (NCE) erythrocytes containing micronuclei was not increased.
- Ratio of PCE/NCE (for Micronucleus assay): The ratio of PCE/NCE in both male and female animals remained unaffected by the treatment, and was statistically not different from the control values.
- Positive control: Endoxan induced in both males and females a marked statistically significant increase in the number of polychromatic cells with micronuclei, indicating the sensitivity of the system. the ratio of PCE/NCE was not changed to a significant extent.
Any other information on results incl. tables
Summary of findings in bone marrow erythrocytes:
Sex |
Dose (mg/kg) |
Sample time |
No. animals |
Erythrocytes |
Erythrocytes with micronuclei |
|||||||||
Poly mean |
Normo mean |
mean |
No |
% |
|
Mut I |
No |
% |
|
Mut I |
||||
Male |
0 |
24 h |
5 |
1000 |
1000 |
0.92 |
2 |
0.16 |
I |
1.0 |
1 |
0.08 |
I |
1.0 |
2000 |
5 |
1000 |
1000 |
1.07 |
2 |
0.18 |
-I |
1.1 |
1 |
0.08 |
-I |
1.0 |
||
Endoxan |
5 |
1000 |
1000 |
0.82 |
23 |
2.32 |
*A |
14.5 |
1 |
0.14 |
-I |
1.7 |
||
Female |
0 |
5 |
1000 |
1000 |
1.03 |
1 |
0.12 |
I |
1.0 |
1 |
0.08 |
I |
1.0 |
|
2000 |
5 |
1000 |
1000 |
0.86 |
1 |
0.08 |
-I |
0.7 |
0 |
0.04 |
-I |
0.5 |
||
Endoxan |
5 |
1000 |
1000 |
0.79 |
21 |
2.10 |
*A |
17.5 |
2 |
0.22 |
*A |
2.8 |
||
Male |
0 |
48 h |
5 |
1000 |
1000 |
0.90 |
2 |
0.20 |
I |
1.0 |
2 |
0.16 |
I |
1.0 |
2000 |
5 |
1000 |
1000 |
0.78 |
1 |
0.08 |
-I |
0.4 |
0 |
0.04 |
-I |
0.2 |
||
Female |
0 |
5 |
1000 |
1000 |
0.96 |
1 |
0.12 |
I |
1.0 |
1 |
0.08 |
I |
1.0 |
|
2000 |
5 |
1000 |
1000 |
0.86 |
1 |
0.14 |
-I |
1.2 |
0 |
0.04 |
-I |
0.5 |
||
Male |
0 |
72 h |
5 |
1000 |
1000 |
1.06 |
2 |
0.18 |
I |
1.0 |
0 |
0.04 |
I |
1.0 |
2000 |
5 |
1000 |
1000 |
1.08 |
1 |
0.10 |
-I |
0.6 |
1 |
0.10 |
-I |
2.5 |
||
Female |
0 |
5 |
1000 |
1000 |
1.05 |
2 |
0.20 |
I |
1.0 |
1 |
0.08 |
I |
1.0 |
|
2000 |
5 |
1000 |
1000 |
1.20 |
1 |
0.14 |
-I |
0.7 |
0 |
0.04 |
-I |
0.5 |
Mut. I = Mutagenic index
- = No difference from control (P>0.05
I = within the normal range
* = Significantly different from control (P<0.05)
A = Outside the normal range
Applicant's summary and conclusion
- Conclusions:
- Isobornyl acetate was determined to be not mutagenic in the mammalian erythrocyte micronucleus test.
- Executive summary:
An in-vivo micronucleus test was performed with isobornyl acetate according to OECD 474. Five mice per sex and per group (70 in total) were exposed to a single dose of test item at 2000 mg/kg bw, based on preliminary results. Cyclophosphamide was used as a positive control (5 mice per sex). Animals were killed 24, 48 and 72 hours after administration of the test compound. For each animal, bone marrow smears were flushed from both femora and the slides were prepared for erythrocyte micronuclei observation. The number of polychromatic and normochromatic erythrocytes containing micronuclei was not increased. The ratio of polychromatic/normochromatic erythrocytes in both male and female animals remained unaffected by the treatment and was statistically not different from the control values, indicating no mutagenicity. Based on these results, isobornyl acetate was determined to be not mutagenic in the mammalian erythrocyte micronucleus test.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)