Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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: 266-100-3 | CAS number: 66068-84-6
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 experimental study report.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
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 the given test chemical after single oral administration in rats and an observation period of 14 days.
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 4-(5,5,6-trimethylbicyclo[2.2.1]hept-2-yl)cyclohexan-1-ol
- EC Number:
- 266-100-3
- EC Name:
- 4-(5,5,6-trimethylbicyclo[2.2.1]hept-2-yl)cyclohexan-1-ol
- Cas Number:
- 66068-84-6
- Molecular formula:
- C16-H28-O
- IUPAC Name:
- 4-(5,5,6-trimethylbicyclo[2.2.1]hept-2-yl)cyclohexanol
- Test material form:
- liquid: viscous
- Details on test material:
- - IUPAC Name of the test chemical: 3-(2,3,3-trimethyl-6-bicyclo[2.2.1]heptanyl)cyclohexan-1-ol
- Common Name: Iso camphyl cyclohexanol
- Molecular Formula: C16H28O
- Molecular Weight: 236.396 g/mol
- SMILES Notation: OC1CCC([C@@H]2[C@@H]3C[C@@H](C(C)(C)[C@@H]3C)C2)CC1
- InChI: 1S/C16H28O/c1-10-14-8-12(16(10,2)3)9-15(14)11-4-6-13(17)7-5-11/h10-15,17H,4-9H2,1-3H3
- Substance Type: Organic
- Physical State: Colourless Viscous 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: Healthy young adult animals were used for the study. 8- 11 weeks at the time of dosing.
- Females (if applicable) nulliparous and non-pregnant: yes
- Weight at study initiation:Minimum: 137 g Maximum: 179 g (Individual body weights were within ± 20% 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.
- Bedding: All cages were provided with corn cobs.
- Room Sanitation:The experimental room floor and work tops were swept and mopped with disinfectant solution every day.
- Cages and water bottle:All the cages and water bottles were changed at least twice every week.
- Diet (e.g. ad libitum):All animals were provided conventional laboratory rodent diet, ad libitum.
- Water (e.g. ad libitum):Aqua guard filtered tap water was provided ad libitum via drinking bottles.
- Acclimation period:Animal nos. 1-3 were acclimatized for five days and 4-6 for seven days prior to administration of the test item.
ENVIRONMENTAL CONDITIONS
- Temperature (°C):Minimum: 19.50°C; Maximum: 22.90°C
- Humidity (%):Minimum: Minimum: 42.90 %; Maximum: 69.10 %
- Air changes (per hr):More than 12 changes per hour
- Photoperiod (hrs dark / hrs light):12 hours light and 12 hours dark
IN-LIFE DATES: From: March 16, 2015 To: April 29, 2015
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 300 mg/kg and 2000 mg/kg
- Amount of vehicle (if gavage):10 ml - Doses:
- G1/ Step I / 300 mg/kg
G1/ Step II / 300 mg/kg
G2/ Step III / 2000 mg/kg
G2/ Step IV / 2000 mg/kg - No. of animals per sex per dose:
- G1/ Step I / 300 mg/kg - 3
G1/ Step II / 300 mg/kg - 3
G2/ Step III / 2000 mg/kg - 3
G2/ Step IV / 2000 mg/kg - 3 - Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical Observation - After test item administration, individual animals were frequently observed at 30 minutes, 1, 2, 3 and 4 hours post dosing on day 0 (day of dosing). Subsequently, all the animals were observed once a day during the 14 day observation period.
Body weight - All rats were weighed on days 0 (prior to dosing), 7 and 14.
Mortality - All animals were observed twice daily (morning and evening) for morbidity and mortality, throughout the acclimatization and study period.
- Necropsy of survivors performed: yes, at the end of 14 day observation period, all the rats were euthanised by overdose of CO2 for external and internal observations. - Statistics:
- not specified
Results and discussion
- Preliminary study:
- not specified
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed in the animals treated with 300 and 2000 mg/kg body weight dose throughout the 14 days observation period.
- Clinical signs:
- other: At 300 and 2000 mg/kg body weight, animals of G1 (Step I and II) and G2 (Step III and IV) were normal throughout the experimental period.
- Gross pathology:
- No external and internal gross pathological changes were seen in all the animals of G1 (Step I and II) and G2 (Step III and IV) treated with 300 and 2000 mg/kg body weight respectively, during terminal sacrifice.
- Other findings:
- not specified
Any other information on results incl. tables
Table 1: Individual Animal Body Weight (g) andBody Weight Changes(%)
Sex: Female
Animal No. |
Group/Step/ Dose (mg/kg body weight) |
Dose Volume (ml) |
Body Weight (gram) |
Body Weight Change (%) |
|||
Day 0 |
Day 7 |
Day 14 |
Day 0-7 |
Day 0-14 |
|||
1 |
G1/ Step I/ 300 |
1.7 |
169 |
193 |
212 |
14.20 |
25.44 |
2 |
1.6 |
160 |
179 |
197 |
11.88 |
23.13 |
|
3 |
1.6 |
162 |
194 |
216 |
19.75 |
33.33 |
|
4 |
G1/ Step II/ 300 |
1.8 |
179 |
213 |
230 |
18.99 |
28.49 |
5 |
1.7 |
170 |
203 |
214 |
19.41 |
25.88 |
|
6 |
1.6 |
160 |
187 |
199 |
16.88 |
24.38 |
|
7 |
G2/ Step III/ 2000 |
1.6 |
164 |
182 |
192 |
10.98 |
17.07 |
8 |
1.6 |
157 |
186 |
198 |
18.47 |
26.11 |
|
9 |
1.8 |
175 |
200 |
218 |
14.29 |
24.57 |
|
10 |
G2/ Step IV/ 2000 |
1.4 |
140 |
164 |
177 |
17.14 |
26.43 |
11 |
1.4 |
141 |
165 |
177 |
17.02 |
25.53 |
|
12 |
1.4 |
137 |
156 |
167 |
13.87 |
21.90 |
|
*= Dose volume calculated based on day 0 body weight,
Table 2: Summary of Animal Body Weight (g) and Body Weight Changes (%)
Sex: Female
Group/Step/Dose (mg/kg body weight) |
Rats Body Weight (g) |
Body Weight Changes (%) |
|||||
Day 0 |
Day 7 |
Day 14 |
0-7 |
0-14 |
|||
G1/ Step I/ 300 |
Mean |
163.67 |
188.67 |
208.33 |
15.28 |
27.30 |
|
SD |
4.73 |
8.39 |
10.02 |
4.05 |
5.35 |
||
N |
3 |
3 |
3 |
3 |
3 |
||
G1/ Step II/ 300 |
Mean |
169.67 |
201.00 |
214.33 |
18.43 |
26.25 |
|
SD |
9.50 |
13.11 |
15.50 |
1.36 |
2.08 |
||
N |
3 |
3 |
3 |
3 |
3 |
||
G2/ Step III/ 2000 |
Mean |
165.33 |
189.33 |
202.67 |
14.58 |
22.59 |
|
SD |
9.07 |
9.45 |
13.61 |
3.76 |
4.84 |
||
N |
3 |
3 |
3 |
3 |
3 |
||
G2/ Step IV/ 2000 |
Mean |
139.33 |
161.67 |
173.67 |
16.01 |
24.62 |
|
SD |
2.08 |
4.93 |
5.77 |
1.86 |
2.40 |
||
N |
3 |
3 |
3 |
3 |
3 |
||
Key: SD = Standard Deviation, n = Number of Animals
Table 3: Individual Animal Clinical Signs and Symptoms
Sex: Female
Animal No. |
Group/Step/ Dose (mg/kg body weight) |
Hours (Day 0) |
||||
1/2 |
1 |
2 |
3 |
4 |
||
1 |
G1/ Step I/ 300 |
1 |
1 |
1 |
1 |
1 |
2 |
1 |
1 |
1 |
1 |
1 |
|
3 |
1 |
1 |
1 |
1 |
1 |
|
4 |
G1/ Step II/ 300 |
1 |
1 |
1 |
1 |
1 |
5 |
1 |
1 |
1 |
1 |
1 |
|
6 |
1 |
1 |
1 |
1 |
1 |
|
7 |
G2/ Step III/ 2000 |
1 |
1 |
1 |
1 |
1 |
8 |
1 |
1 |
1 |
1 |
1 |
|
9 |
1 |
1 |
1 |
1 |
1 |
|
10 |
G2/ Step IV/ 2000 |
1 |
1 |
1 |
1 |
1 |
11 |
1 |
1 |
1 |
1 |
1 |
|
12 |
1 |
1 |
1 |
1 |
1 |
|
Animal No. |
Group/Step/ Dose (mg/kg body weight) |
Days post dosing |
|||||||||||||||||||||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||||||||||||||||||
1 |
G1/ Step I/ 300 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
||||||||||||||||
2 |
1 |
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 |
G1/ Step II/ 300 |
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 |
|||||||||||||||||
7 |
G2/ Step III/ 2000 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
||||||||||||||||
8 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|||||||||||||||||
9 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|||||||||||||||||
10 |
G2/ Step IV/ 2000 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
||||||||||||||||
11 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|||||||||||||||||
12 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|||||||||||||||||
Key:1 = Normal
Table 4: Individual Animal Mortality Record
Sex: Female
Animal No. |
Group/Step/ Dose (mg/kg body weight) |
Day of Observation (Day 0 to 14) |
|
Morning Observations |
Evening Observations |
||
1 |
G1/ Step I/ 300 |
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 |
G1/ Step II/ 300 |
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 |
|
7 |
G2/ Step III/ 2000 |
No mortality and morbidity |
No mortality and morbidity |
8 |
No mortality and morbidity |
No mortality and morbidity |
|
9 |
No mortality and morbidity |
No mortality and morbidity |
|
10 |
G2/ Step IV/ 2000 |
No mortality and morbidity |
No mortality and morbidity |
11 |
No mortality and morbidity |
No mortality and morbidity |
|
12 |
No mortality and morbidity |
No mortality and morbidity |
|
Table 5: Gross Necropsy Observation
Sex: Female Mode of Death: Terminal Sacrifice
Animal No. |
Group/Step/ Dose (mg/kg body weight) |
Gross Observation |
|
External |
Internal |
||
1 |
G1/ Step I/ 300 |
No abnormality detected |
No abnormality detected |
2 |
No abnormality detected |
No abnormality detected |
|
3 |
No abnormality detected |
No abnormality detected |
|
4 |
G1/ Step II/ 300 |
No abnormality detected |
No abnormality detected |
5 |
No abnormality detected |
No abnormality detected |
|
6 |
No abnormality detected |
No abnormality detected |
|
7 |
G2/ Step III/ 2000 |
No abnormality detected |
No abnormality detected |
8 |
No abnormality detected |
No abnormality detected |
|
9 |
No abnormality detected |
No abnormality detected |
|
10 |
G2/ Step IV/ 2000 |
No abnormality detected |
No abnormality detected |
11 |
No abnormality detected |
No abnormality detected |
|
12 |
No abnormality detected |
No abnormality detected |
|
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Conclusions:
- Under these study conditions, the acute oral toxicity dose (LD50) was considered to be >2000 mg/kg bw, when female Wistar rats were treated with the given test chemical via oral route. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that the given test chemical does not exhibit acute oral toxicity. CLP Classification "Not classified"
- Executive summary:
Acute oral toxicity study of the given test chemical was conducted as per OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method) in Wistar female rats.
Twelve female Wistar rats were selected for acute oral toxicity study. The animals were fasted for minimum 16-18 hours prior to dosing and for 4 hours post dosing, with feed withheld but drinking water provided ad libitum. The time intervals between dosing were determined by the onset, duration and severity of toxic signs.
Three rats of group G1 (Step I) were dosed with starting dose of 300 mg/kg body weight and no mortality was observed.
Based on the results from G1 (Step I), additional three animals of group G1 (Step II) were dosed with 300 mg/kg body weight. As there was no mortality at group G1 (Step I and II) dose levels, three rats of group G2 (Step III) was dosed with 2000 mg/kg body weight and no mortality was observed so another three rats of group G2 (Step IV) were dosed with 2000 mg/kg body weight. Since there was no mortality in both the groups G1 (Step I and II) and G2 (Step III and IV), further dosing was not required.
Body weights were recorded on day 0 (prior to dosing) 7 and 14. Mean body weight of all the animals (Step I, Step II, Step III and Step IV) treated with 300 and 2000 mg/kg body weight and was observed with gain on day 7 and 14, as compared to day 0.
At 300 and 2000 mg/kg body weight, animals of G1 (Step I and II) and G2 (Step III and IV) were normal throughout the experimental period.
No external and internal gross pathological changes were seen in all the animals of G1 (Step I and II) and G2 (Step III and IV) treated with 300 and 2000 mg/kg body weight respectively, during terminal sacrifice.
Under these study conditions, the acute oral toxicity dose (LD50) was considered to be >2000 mg/kg bw, when female Wistar rats were treated with the given test chemical via oral route. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that the given test chemical does not exhibit acute oral toxicity. CLP Classification "Not classified"
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.
