3-(5,5,6-trimethylbicyclo[2.2.1]hept-2-yl)cyclohexan-1-ol

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:

2014

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

Test material information

Constituent 1

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

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.