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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
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

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 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
The objective of the study was to assess the irritant and/or corrosive effects of test chemical after dermal application on the intact skin of rabbits.
GLP compliance:
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:
3-(5,5,6-trimethylbicyclo[2.2.1]hept-2-yl)cyclohexanol
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:Store in tightly closed container in a dry, cool and well-ventilated place. Protect from light, including direct sunrays.- Other:Handling and DisposalSafety precautions : Avoid spilling, skin and eye contact. Aprons, caps, mask,gloves and goggles will be used to ensure the health and safety of the personnel.Disposal : The remaining unused test item (if any) was disposed as per internal SOPs of sa-FORD.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS- Source:Procured from RABBI ROOF, Hyderabad
.- Age at study initiation:4 to 5 Months (Approximately)
- Weight at study initiation: 1.874-2.272 kg
- Housing:The animals were housed individually in stainless steel cages in a controlled environment.
- Diet (e.g. ad libitum): Conventional laboratory rabbit diet (Nutrivet Life Sciences, Pune), ad libitum
- Water (e.g. ad libitum):Aqua guard filtered tap water, ad libitum-
Acclimatization period: Rabbits were acclimatized to the test conditions for a period of 5 days (Animal No. 1) and 9 days (Animal No. 2 and 3) prior to the application of the test item.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.30-22.50 °C
- Humidity (%): 45.00-68.40 %
- Air changes (per hr):More than 12 changes per hour
- Photoperiod (hrs dark / hrs light):12-hrs light/12-hrs dark

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
other: distilled water
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5 ml
- Concentration (if solution): No data available

VEHICLE
- Amount(s) applied (volume or weight with unit):0.5 ml distilled water
- Concentration (if solution): No data available
- Lot/batch no. (if required): No data available- Purity: No data available
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 male rabbits
Details on study design:
TEST SITE
- Area of exposure: approximately 6 X 6 cm at contralateral sites
- Type of wrap if used: porous gauze dressing and non-irritating tape (Micropore 3”)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test item was removed by using cotton soaked in distilled water
- Time after start of exposure: 4hr

Control site: 0.5 ml distilled water was applied at control site.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1 ,#2 and #3
Time point:
other: At 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal: #1 ,#2 and #3
Time point:
other: At 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The patch was removed after 4 hours and rabbits were observed for erythema and oedema at 1, 24, 48 and 72 hours after patch removal, evaluated and graded as per draize method. In Animal Nos. 1, 2 and 3 at 1 hour observation after post patch removal, revealed no erythema and oedema at 1, 24, 48 and 72 hour observation. The individual mean score at 24, 48 and 72 hours for Animal Nos. 1, 2 and 3 were 0.00, 0.00, 0.00 and 0.00, 0.00, 0.00, for erythema and oedema formation, respectively.
Other effects:
Clinical Observation
No systemic toxicity was observed at treated rabbits during the experimental period.
Mortality
No mortality was observed during the observation period.
Body weight
Body weight of all animals was comparable with pre-treatment body weight.

Any other information on results incl. tables

Table 1

Skin Reaction

 

In Treated area Dose:0.5 ml of test item                                                                                             Sex:Male

 

Animal

No.

Test

Treated

 area*

Erythema score

Oedema score

1h

24h

48h

72h

1h

24h

48h

72h

1

Initial

Right

0

0

0

0

0

0

0

0

2

Confirmatory

Right

0

0

0

0

0

0

0

0

3

Left

0

0

0

0

0

0

0

0

 

In Control areaDose:0.5 ml of distilled water                                                Sex:Male

 

Animal

No.

Test

Treated area*

Erythema score

Oedema score

1h

24h

48h

72h

1h

24h

48h

72h

1

Initial

Left

0

0

0

0

0

0

0

0

2

Confirmatory

Left

0

0

0

0

0

0

0

0

3

Right

0

0

0

0

0

0

0

0

Key: h = Hour.

Erythema                                                                                                                                           Oedema

0 = No erythema                                                                                                                            0 = No oedema


Table 1 Continued…

Mean Individual Animal Score at 24, 48 and 72 hours

 

                     Animal Number                  

Observations                      

1

2

3

Erythema

0.00

0.00

0.00

Oedema

0.00

0.00

0.00

 

  

Table 2

Individual Animal BodyWeight

Sex:Male

Animal

No.

Body Weight (kg)

Prior to Dosing

At termination

1

2.272

2.330

2

1.874

1.912

3

1.938

1.948

Table 3

Individual AnimalClinicalSigns

Sex:Male

Animal

No.

Days (Post dosing Observation)

0

1

2

3

1

1

1

1

1

2

1

1

1

1

3

1

1

1

1

Key: 1 = Normal.

Applicant's summary and conclusion

Interpretation of results:
other: Not irritating
Conclusions:
The individual mean score at 24, 48 and 72 hours for Animal Nos. 1, 2 and 3 were 0.00, 0.00, 0.00 and 0.00, 0.00, 0.00, for erythema and oedema formation, respectively.Hence, the test chemical was regarded as non-Irritating to the skin of male New Zealand White rabbits under the experimental conditions tested and is thus not classified as a skin irritant.
Executive summary:

Acute Dermal Irritation/corrosion Study of test chemical was performed as per OECD guideline No. 404 using three healthy young adult male. The hairs of all the rabbits were clipped at contralateral sites, approximately 24 hours prior to treatment. A dose of 0.5 g of test item (moistened with 0.5 ml distilled water) was applied to the skin, over an area of approximately 6 x 6 cm clipped of hair on one side of rabbits. The other untreated side was kept as control area and0.5 ml of distilled water was applied at this site. At the end of 4 hours, the gauze patch was removed and test item application site was wiped with water without altering the integrity of the epidermis. Initially, the test item was applied to the clipped area of skin of one rabbit. The test site was covered with gauze patch. After 4 hours of exposure in animal no. 1, no erythema and no oedema observed at 1, 24 and 48 hour of observation hence a confirmatory test was conducted on additional two rabbits (No. 2 and 3) to confirm the non-irritant nature of the test item.

The patch was removed after 4 hours and rabbits were observed for erythema and oedema at 1, 24, 48 and 72 hours post patch removal, evaluated and graded as per Draize method. In animal no. 2 and 3 at 1 hour observation post patch removal, revealed no erythema and no oedema. At 24, 48 and 72 hour post patch removal, animals showed no erythema and no oedema.

The individual mean score at 24, 48 and 72 hours for Animal Nos. 1, 2 and 3 were 0.00, 0.00, 0.00 and 0.00, 0.00, 0.00, for erythema and oedema formation, respectively Hence, it was concluded that the test chemical was Non-Irritating to the skin of male New Zealand White rabbits under the experimental conditions tested.