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EC number: 222-294-1 | CAS number: 3407-42-9
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- Long-term toxicity to aquatic invertebrates
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- Toxicological Summary
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- Additional toxicological data

Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- 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 402 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- The objective of the study was to assess the dermal toxicity of test chemical after single dose application by dermal route in rats.
- GLP compliance:
- yes
- Test type:
- standard acute 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:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: In-House Bred
- Age at study initiation: No data available-
- Weight (Prior to Treatment):Male: 225-245 g ; Female: 215-231 g
- Fasting period before study: No data available
- Housing:The animals were housed individually in polycarbonate cages with corn cob 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: All animals were acclimatized to the test conditions for 5 days prior to administration of the test item.ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.20-24.40°C
- Humidity (%): 36.60-57.30%
- Air changes (per hr): More than 12 changes per hour
- Photoperiod (hrs dark / hrs light):12-hrs light/:12-hrs dark
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: The test item was applied uniformly over clipped dorsal area of rat skin.
- % coverage: Approximately 10% body surface area of rat.
- Type of wrap if used: Porous gauze dressing and non-irritating tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The residual test item was removed by using distilled water.
- Time after start of exposure: 24-hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A limit dose of 2000 mg/ kg body weight of test item was applied.
- Constant volume or concentration used: Yes
- For solids, paste formed: No VEHICLE
- Amount(s) applied (volume or weight with unit): No data available
- Concentration (if solution): No data available
- Lot/batch no. (if required): No data available
- Purity: No data available - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- Total: 10 rats 2000 mg/kg: 5 males, 5 females
- Control animals:
- no
- 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 signs, body weight, local signs/skin reactions and mortality. - Statistics:
- No statistical analysis was performed since the study was terminated with limit test.
Results and discussion
- Preliminary study:
- No data available
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Non toxic to animals
- Mortality:
- No mortality was observed at 2000 mg/kg body weight during the 14 day observation period.
- Clinical signs:
- other: No systemic or local signs of toxicity were observed at 2000 mg/kg body weight during the experimental period.
- Gross pathology:
- The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality.
- Other findings:
- No data available
Any other information on results incl. tables
Table 1: Individual Animal Body Weight (g) andBody Weight Changes(%)
Dose:2000 mg/ kg bodyweight Density:0.96365
Animal No. |
Sex |
Dose (ml) Applied* |
Body Weight (gram) |
Body Weight Change (%) |
|||
Day 0 |
Day 7 |
Day 14 |
Day 0-7 |
Day 0-14 |
|||
1 |
Male |
0.49 |
236 |
243 |
249 |
2.97 |
5.51 |
2 |
0.48 |
231 |
239 |
247 |
3.46 |
6.93 |
|
3 |
0.47 |
225 |
248 |
274 |
10.22 |
21.78 |
|
4 |
0.51 |
245 |
270 |
287 |
10.20 |
17.14 |
|
5 |
0.48 |
233 |
240 |
260 |
3.00 |
11.59 |
|
6 |
Female |
0.45 |
215 |
223 |
215 |
3.72 |
0.00 |
7 |
0.47 |
227 |
231 |
233 |
1.76 |
2.64 |
|
8 |
0.48 |
231 |
228 |
233 |
-1.30 |
0.87 |
|
9 |
0.48 |
231 |
236 |
237 |
2.16 |
2.60 |
|
10 |
0.45 |
215 |
213 |
217 |
-0.93 |
0.93 |
Key:* = Based on density of test item and day 0 body weight taken prior to dose application.
Table 2: Individual Animal Clinical Signs and Symptoms
Dose:2000 mg/kg body weight
Animal No. |
Sex |
Hour(s) - Day 0 |
Day |
||||||||||||||||
1 |
2 |
3 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
1 |
Male |
1 |
1 |
1 |
1 |
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 |
1 |
1 |
1 |
1 |
|
3 |
1 |
1 |
1 |
1 |
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 |
1 |
1 |
1 |
1 |
|
5 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
6 |
Female |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
7 |
1 |
1 |
1 |
1 |
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 |
1 |
1 |
1 |
1 |
|
9 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
10 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
Key: 1 = Normal
Table 3: Individual Animal Mortality Record
Dose:2000 mg/kg body weight
Animal No. |
Sex |
Days of Observation (0 to 14) |
|
Morning Observations |
Evening Observations |
||
1 |
Male |
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 |
Female |
No mortality and morbidity |
No mortality and morbidity |
7 |
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 |
No mortality and morbidity |
No mortality and morbidity |
Table 4:Summaryof Animal Body Weight (g) and Body Weight Changes (%)
Dose:2000 mg/kg body weight
Sex |
Body Weight (gram) |
Body Weight Changes (%) |
||||
Day 0 |
Day 7 |
Day 14 |
Day 0-7 |
Day 0-14 |
||
Male |
Mean |
234.00 |
248.00 |
263.40 |
5.97 |
12.59 |
SD |
7.35 |
12.79 |
17.01 |
3.88 |
6.86 |
|
n |
5 |
5 |
5 |
5 |
5 |
|
Female |
Mean |
223.80 |
226.20 |
227.00 |
1.08 |
1.41 |
SD |
8.20 |
8.76 |
10.20 |
2.14 |
1.17 |
|
n |
5 |
5 |
5 |
5 |
5 |
Keys:SD= Standard deviation, n = Number of animals
Table 5: GrossNecropsyObservation
Dose:2000 mg/kg body weight Mode of Death:Terminal Sacrifice
Animal No. |
Sex |
Gross Observation |
|
External |
Internal |
||
1 |
Male |
No abnormalities detected |
No abnormalities detected |
2 |
No abnormalities detected |
No abnormalities detected |
|
3 |
No abnormalities detected |
No abnormalities detected |
|
4 |
No abnormalities detected |
No abnormalities detected |
|
5 |
No abnormalities detected |
No abnormalities detected |
|
6 |
Female |
No abnormalities detected |
No abnormalities detected |
7 |
No abnormalities detected |
No abnormalities detected |
|
8 |
No abnormalities detected |
No abnormalities detected |
|
9 |
No abnormalities detected |
No abnormalities detected |
|
10 |
No abnormalities detected |
No abnormalities detected |
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Conclusions:
- No mortality was observed at 2000 mg/kg body weight during the 14 day observation period. No systemic or local signs of toxicity were observed at 2000 mg/kg body weight during the experimental period. The male and female animals were observed with body weight gain compared to day 0 throughout the experiment. The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality. Based on the results, the acute dermal median lethal dose of test chemical was considered to be greater than 2000 mg/kg body weight.
- Executive summary:
The acute toxicity of test chemical was determined after single dose application by dermal route in rats. This study was performed according to OECD 402 Guidelines. Five male and five female Wistar rats were treated with test item by a single dermal application at the dose level of 2000 mg/kg body weight and observed for 14 days after treatment. Since no test item related mortality was observed, the study was terminated with limit test only. The test item was applied uniformly over clipped dorsal area of rat skin. The porous gauze dressing was put on the intact skin and wrapped around the abdomen and it was anchored with non-irritating tape. After 24 hour application period, the residual test item was removed by using distilled water. The skin reactions were assessed. The animals were observed daily for clinical signs, mortality. The body weight changes were recorded on day 0 and on day 7 and day 14. All animals were necprosied and examined macroscopically. No statistical analysis was performed since the study was terminated with limit test. No mortality was observed at 2000 mg/kg body weight during the 14 day observation period. No systemic or local signs of toxicity were observed at 2000 mg/kg body weight during the experimental period. The male and female animals were observed with body weight gain compared to day 0 throughout the experiment. The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality. Based on the results, the acute dermal median lethal dose of test chemical was considered to be greater than 2000 mg/kg body weight.
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