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EC number: 222-294-1 | CAS number: 3407-42-9
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Data is from study report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Principles of method if other than guideline:
- The aim of this study was to assess the toxicity potential of test chemical after single oral administration in rats.
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 3-(5,5,6-trimethylbicyclo[2.2.1]hept-2-yl)cyclohexan-1-ol
- EC Number:
- 222-294-1
- EC Name:
- 3-(5,5,6-trimethylbicyclo[2.2.1]hept-2-yl)cyclohexan-1-ol
- Cas Number:
- 3407-42-9
- Molecular formula:
- C16H28O
- IUPAC Name:
- 3-(5,5,6-trimethylbicyclo[2.2.1]hept-2-yl)cyclohexanol
- Test material form:
- liquid: viscous
- Details on test material:
- - Name of test material (as cited in study report):3-(5, 5, 6-trimethylbicyclo [2.2.1] hept-2-yl) cyclohexan-1-ol
- Molecular formula :C16H28O
- Molecular weight :236.39 g/mol
- Substance type:Organic
- Physical state:Colourless Liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:In-House Bred
- Age at study initiation:8- 11 weeks at the time of dosing
- Weight at study initiation: 168-192 g (Individual body weights were within ± 5% prior to treatment after overnight fasting)
- Fasting period:The animals were fasted for minimum 16-18 hours prior to dosing and for 3-4 hours post dosing.
- Housing: The animals were housed individually in polycarbonate cages with corn cobs as bedding in a controlled environment.
- Diet (e.g. ad libitum): Conventional laboratory rodent diet (Nutrivet Life Sciences, Pune), ad libitum
- Water (e.g. ad libitum): Aqua guard filtered tap water, ad libitum
- Acclimation period: Animal numbers 1-3 were acclimatized for five days, and 4-6 for seven days prior to administration of the test item.
ENVIRONMENTAL CONDITIONS
- Temperature (°C):20.40 - 23.10°C
.- Humidity (%):Minimum: 37.40 - 56.00%
- Air changes (per hr): More than 12 changes per hour
- Photoperiod (hrs dark / hrs light): 12-hrs light/12-hrs dark
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage):10 ml
- Justification for choice of vehicle: Corn oil was selected because test item was not miscible in distilled water.
- Lot/batch no. (if required): MKBD4650- Purity: No data av available
MAXIMUM DOSE VOLUME APPLIED:10 ml/kg body weight - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 female rats
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical Observation, body weight and mortality. - Statistics:
- No data available
Results and discussion
- Preliminary study:
- No data available
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other:
- Remarks:
- No mortality observed
- Mortality:
- No mortality was observed in the animals treated with 2000 mg/kg throught out the 14 days observation period post dosing.
- Clinical signs:
- other: At 2000 mg/kg, animal nos. 1, 2, 3, 4 and 6 were observed normal at 30 minutes, mild to moderate diarrhea at 1, 2, 3 and 4 hours and mild epistaxis at 3 and 4 hours followed by normal clinical sign till day 14. Additionally, animal no. 2 was observed with
- Gross pathology:
- No external or internal gross pathological changes were seen in all the six animals treated with 2000 mg/kg body weight during terminal sacrifice.
Any other information on results incl. tables
Table 1: Individual Animal Body Weight (g) andBody Weight Changes(%)
Sex:Female
Animal No. |
Group/ Dose (mg/kg) |
Body Weight (gram) |
Body Weight Change (%) |
|||
Day 0 |
Day 7 |
Day 14 |
Day 0-7 |
Day 0-14 |
||
1 |
G1/ 2000 |
174 |
193 |
216 |
10.92 |
24.14 |
2 |
171 |
185 |
210 |
8.19 |
22.81 |
|
3 |
168 |
192 |
202 |
14.29 |
20.24 |
|
4 |
192 |
205 |
218 |
6.77 |
13.54 |
|
5 |
178 |
149 |
178 |
-16.29 |
0.00 |
|
6 |
174 |
189 |
198 |
8.62 |
13.79 |
Table 2: Summary of Animal Body Weight (g) and Body Weight Changes (%)
Sex:Female
Group/ Dose (mg/kg) |
Rats Body Weight (g) |
Body Weight Changes (%) |
||||
Day 0 |
Day 7 |
Day 14 |
0-7 |
0-14 |
||
G1/ 2000 |
Mean |
176.17 |
185.50 |
203.67 |
5.42 |
15.75 |
SD |
8.45 |
19.10 |
14.77 |
10.95 |
8.91 |
|
n |
6 |
6 |
6 |
6 |
6 |
Keys:SD = Standard Deviation, n = Number of Animals
Table 3: Individual Animal Clinical Signs and Symptoms
Sex:Female
Animal No. |
Group/ Dose (mg/kg) |
Hours (Day 0) |
||||
1/2 |
1 |
2 |
3 |
4 |
||
1 |
G1/ 2000 |
1 |
49++ |
49+ |
64+ 49+ |
64+ 49+ |
2 |
1 |
49++ |
49+ |
64+ 49+ |
64+ 49+ |
|
3 |
1 |
49++ |
49+ |
64+ 49+ |
64+ 49+ |
|
4 |
1 |
49+ |
49++ |
64+ 49++ |
64+ 49+ |
|
5 |
1 |
1 |
49+ |
64+ 49+ |
49+ 64+ |
|
6 |
1 |
49++ |
49++ |
64+ 49+ |
49+ 64+ |
Animal No. |
Group/ Dose (mg/kg) |
Days post dosing |
|||||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
1 |
G1/ 2000 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
2 |
182 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
3 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
4 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
5 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
6 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
Keys:1 = Normal, 49 = Diarrhoea, 64 = Epistaxis, 182 = Soiled anal region with fecal material,+= Mild,++= Moderate
Table 4: Individual Animal Mortality Record
Sex:Female
Animal No. |
Group/ Dose (mg/kg) |
Day of Observation (Day 0 to 14) |
|
Morning Observations |
Evening Observations |
||
1 |
G1/ 2000 |
No mortality and morbidity |
No mortality and morbidity |
2 |
No mortality and morbidity |
No mortality and morbidity |
|
3 |
No mortality and morbidity |
No mortality and morbidity |
|
4 |
No mortality and morbidity |
No mortality and morbidity |
|
5 |
No mortality and morbidity |
No mortality and morbidity |
|
6 |
No mortality and morbidity |
No mortality and morbidity |
Table 5: Gross Necropsy Observation
Sex:Female
Animal No. |
Group/ Dose (mg/kg) |
Mode of Death |
Gross Observation |
|
External |
Internal |
|||
1 |
G1/ 2000 |
Terminal sacrifice |
No abnormality detected |
No abnormality detected |
2 |
Terminal sacrifice |
No abnormality detected |
No abnormality detected |
|
3 |
Terminal sacrifice |
No abnormality detected |
No abnormality detected |
|
4 |
Terminal sacrifice |
No abnormality detected |
No abnormality detected |
|
5 |
Terminal sacrifice |
No abnormality detected |
No abnormality detected |
|
6 |
Terminal sacrifice |
No abnormality detected |
No abnormality detected |
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Conclusions:
- Body weight gain was observed in all the animals treated with 2000 mg/kg body weight, during the 14-day observation period. At 2000 mg/kg, animal number 1, 2, 3, 4 and 6 were observed normal at 30 minutes, mild to moderate diarrhea at 1, 2, 3 and 4 hours and mild epistaxis at 3 and 4 hours followed by normal clinical sign till day 14. Additionally, animal number 2 was observed with soiled anal region with fecal material on day1. Animal number 5 was observed normal at 30 minutes and 1 hour, mild diarrhea at 2, 3 and 4 hours and mild epistaxis at 3 and 4 hours followed by normal clinical sign till day 14. No external and internal gross pathological changes were seen in all the six animals treated with 2000 mg/kg body weight during terminal sacrifice
The acute oral LD50 value for the test chemical was considered to be greater than 2000 mg/kgbw. - Executive summary:
An acute oral toxicity study of test chemical was conducted in female Wistar rats as per OECD No. 423.Six Wistar female rats were for the acute oral toxicity study. Prior to dosing, the animals were fasted for minimum 16-18 hours and for 3-4 hours post dosing, with food withheld but drinking water provided ad libitum. Corn oil was selected as the vehicle because test item was not miscible in distilled water. Three rats of the first group were dosed with starting dose of 2000mg/kgbw and the animals didnot show any mortality so another three rats of the same group were dosed with 2000 mg/kgbw and no mortality was observed. Hence, further dosing was stopped. Body weight gain was observed in all the animals treated with 2000 mg/kg body weight, during the 14-day observation period. At 2000 mg/kg, animal number 1, 2, 3, 4 and 6 were observed normal at 30 minutes, mild to moderate diarrhea at 1, 2, 3 and 4 hours and mild epistaxis at 3 and 4 hours followed by normal clinical sign till day 14. Additionally, animal number 2 was observed with soiled anal region with fecal material on day1. Animal number 5 was observed normal at 30 minutes and 1 hour, mild diarrhea at 2, 3 and 4 hours and mild epistaxis at 3 and 4 hours followed by normal clinical sign till day 14. No external and internal gross pathological changes were seen in all the six animals treated with 2000 mg/kg body weight during terminal sacrifice. The acute oral LD50 value for the test chemical was considered to be greater than 2000 mg/kgbw.
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