Registration Dossier

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

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

Constituent 1
Chemical structure
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:
.
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- Lot/batch No.:Lot 1/14- Storage condition of test material:Stored in tightly closed container in a dry, cool and well- ventilated place. Protected from light, including direct sunrays.- Other:Handling and DisposalSafety precautions : Avoidd spilling, skin and eye contact. Aprons, caps, mask, gloves and goggles were used to ensure the health and safety of the personnel.Disposal : The remaining unused test item was disposed as per internal SOPs of sa-FORD.

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 at Sa-Ford,
Animal Facility- 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-hoursTEST 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:
No systemic or local signs of toxicity were observed at 2000 mg/kg body weight during the experimental period.
Body weight:
The male and female animals were observed with body weight gain compared to day 0 throughout the experiment.
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

 


 

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Conclusions:
Based on the results, the acute dermal median lethal dose of test chemical was > 2000 mg/kg body weight.
Executive summary:

An acute dermal toxicity study of test chemical was conducted on male and female Wistar rats as per OECD No. 402. Healthy young adult rats were randomly selected and 24 hours prior to dermal application of test item, approximately 10% of body surface area of each rat was clipped. A limit dose of 2000 mg/kg body weight of test item was applied on the clipped skin by single dermal application and observed for 14 days after treatment. At day 14, all animals were necropsied and examined macroscopically. No mortality was observed in any animal till the end of the experimental period, and the external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality. Thus, the acute dermal median lethal dose of test chemical was > 2000 mg/kg body weight and does not exhibit acute dermal toxicity.