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EC number: 261-118-8 | CAS number: 58096-47-2
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11.01.2018 to 06.02.2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Decahydro-1,1,7-trimethyl-3a,7-methano-3aH-cyclopentacyclooct-3-yl formate
- EC Number:
- 261-118-8
- EC Name:
- Decahydro-1,1,7-trimethyl-3a,7-methano-3aH-cyclopentacyclooct-3-yl formate
- Cas Number:
- 58096-47-2
- Molecular formula:
- C16H26O2
- IUPAC Name:
- decahydro-1,1,7-trimethyl-3a,7-methano-3aH-cyclopentacyclooct-3-yl formate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- CAS No: 58096-47-2
EC No: 261-118-8
Chemical Name: Decahydro-1,1,7-trimethyl-3a,7-methano-3aH-cyclopentacyclooct-3-yl formate
Trade Name: Clovanyl-3-Formate (CARYOLAN)
Molecular formula: C16H26O2
Molecular weight: 250.379
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Details on Test Animals
Species : Rat (Rattus norvegicus)
Strain : Wistar rats
Source : Geniron Biolabs Pvt. Ltd.
No.93, Solur, Anekal-Thally Road, Anekal
Bengaluru – 562106, India
No. of groups : One treatment group – 4 steps
(G1-FTS & STS and G2-FTS & G2-STS)
No. of animals : 3 animals (females) / treatment step
Age at treatment : 9 to 12 Weeks
Body weight range at treatment : 197.5 to 228.4 g
Note: At the time of selection of animals for each treatment step, the weight variation did not exceed ± 20 per cent of the mean body weight of any previously dosed animals.
Identification : By rat accession number. Identification of individual rats was by cage card and turmeric colour body markings. The rat accession number was allotted during the course of the study. The temporary body marking during acclimatization period was done with crystal violet.
Acclimatization : After physical examination for good health and suitability for experiment, the animals were acclimatized six days for G1-FTS, eight days for G1-STS, 10 days for G2-FTS and 12 days for G2-STS before treatment. Animals were observed once daily during acclimatization period. Females were nulliparous and non-pregnant.
Details on Environmental Conditions
Rats were housed under standard laboratory conditions, air conditioned with adequate fresh air supply (13.4 air changes/hour). Environment: with temperature 21 to 24°C, relative humidity 65 to 68%, with 12 hours light and 12 hours dark cycle.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The undiluted test item as supplied by the sponsor was administered a dose of 300 mg/kg bodyweight (0.29 mL//kg) for the treatment steps (G1-FTS & G1STS) and a dose of 2000 mg/kg (1.95 mL//kg) for the treatment steps (G2-FTS & G2-STS) as a single oral gavage to rats fasted for 16 to 18 hours (access to water will not be interrupted) based on the specific gravity of the test item which is 1.024 (as per TIDS provided by the sponsor).
Each animal was administered the test item orally by gavage using disposable plastic syringe attached with metal feeding canula. Animals were fed approximately 3 to 4 hours after dosing. - Doses:
- 300 mg/kg bodyweight and 2000 mg/kg bodyweight
- No. of animals per sex per dose:
- 3 females per dose
- Control animals:
- yes
- Details on study design:
- To determine the acute toxicity, a stepwise procedure was employed with the use of three animals of a single sex (female), at each step. Sufficient information was obtained on the acute toxicity of the test item for its classification. The test item was administered orally to a group of experimental animals at one of the defined doses (i.e. 300 mg/kg body weight) as a first step (G1-FTS). As all the rats survived at this step, the test was continued at the same dose of 300 mg/kg bodyweight (G1-STS), all the rats survived at this step, the test was continued at the next higher dose of 2000 mg/kg bodyweight (G2-FTS), all the rats survived at this step, hence the test was confirmed with three additional animals with the same dose of
2000 mg/kg body weight (G2-STS). No test item-related mortality was observed, and hence testing was stopped and the LD50 cut-off value was arrived.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None observed
- Clinical signs:
- other: Reported in table below
- Gross pathology:
- Reported in table below
Any other information on results incl. tables
Table 1: Body weight, bidy weight changes and pre-terminal deaths
Group and Dose (mg/kg body weight) |
Rat No. |
Sex |
Body weight (g) |
Day of Death (Time of Death) |
No. dead/ No. tested |
Pre-terminal deaths (%) |
|||||
Initial (Day 1) |
8thday |
Weight change (day 8 – Initial) |
15thday |
Weight change (day 15 – Initial) |
At Death |
||||||
G1 (FTS) 300
|
Rm7691 |
F |
204.8 |
209.8 |
5.0 |
219.6 |
14.8 |
- |
NA |
0/3
|
0 |
Rm76982 |
F |
228.4 |
234.9 |
6.5 |
242.1 |
13.7 |
- |
NA |
|||
Rm7693 |
F |
201.4 |
210.6 |
9.2 |
219.3 |
17.9 |
- |
NA |
|||
G1 (STS) 300
|
Rm7694 |
F |
227.8 |
232.4 |
4.6 |
238.4 |
10.6 |
- |
NA |
0/3
|
0 |
Rm7695 |
F |
204.7 |
211.6 |
6.9 |
218.1 |
13.4 |
- |
NA |
|||
Rm7696 |
F |
203.4 |
210,5 |
7.1 |
215.6 |
12.2 |
- |
NA |
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- Based on the results of the present study, the test item Decahydro-1,1,7-trimethyl-3a,7-methano-3aH-cyclopentacyclooct-3-yl formate (Clovanyl-3-formate)LD50 was determined to be 5000 mg/kg body weight or Unclassified as per LD50 cut-off value.
- Executive summary:
The acute oral toxicity study with Clovanyl-3-Formate (Caryolan)in Wistar rats was conducted to assess the toxicological profile of the test item.
The undiluted test item was administered as a single oral gavage to overnight fasted (16 to 18 hours) three female rats (G1-FTS) at the dose of 300 mg/kg (0.29 mL/kg) body weight. There were no clinical signs of toxicity and pre-terminal deaths. Hence, three additional female rats were tested at the same dose of 300 mg/kg (0.29 mL/kg) body weight (G1-STS). There were no clinical signs of toxicity and pre-terminal deaths. Based on the scheme - Annex 2c of the guideline OECD 423, three additional female rats were tested at the next higher dose of 2000 mg/kg 1.99 mL/kg) body weight (G2-FTS). There were no clinical signs of toxicity and pre-terminal deaths. Hence, three additional female rats were tested at the same dose of 2000 mg/kg (1.99 mL/kg) body weight (G2-STS). There were no clinical signs of toxicity and pre-terminal deaths, dosing was stopped.
The rats were observed for mortality and clinical signs for 14 days post treatment. Body weights were recorded prior to dosing on day 1 and again on days 8 and 15. Necropsy was performed for all the rats at termination. All survived rats gained weight during experimental period. There were no gross pathological changes at necropsy.
Based on the results of the present study, The LD50is 5000 mg/kg or unclassified as per the as per LD50cut-off value.
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