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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Justification for type of information:
data is from experimental reports

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
To assess the dermal irritation parameter of the test chemical in accordance with OECD 404
GLP compliance:
no

Test material

Constituent 1
Chemical structure
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]heptan-2-yl}cyclohexan-1-ol
Test material form:
liquid
Details on test material:
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: Liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Sex: Female
- Age at study initiation: 10-12 weeks
- Weight at study initiation: 2 kg+ 200g
- Housing:animals were housed individually in stainless steel cages provided with steel mesh bottom and facilities for food and water
- Diet (e.g. ad libitum): Pelleted feed supplied by Pranav Agro
- Water (e.g. ad libitum):Community tap water kept in glass bottles, ad libitum
- Acclimation period: The healthy rabbits selected for study were acclimatized to laboratory conditions one week prior to testing
- Identification: By cage tag and corresponding color body marking

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-25 degC
- Humidity (%): relative humidity - 40-60%
- Air changes (per hr): Air conditioned rooms with 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): illumination cycle set to 12 hours artificial fluorescent light and 12 hours dark

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.5gm
Duration of treatment / exposure:
4 hours
Observation period:
24,48 and 72 hours after patch removal till 14days
Number of animals:
3- [1- initial test; 2- confirmatory test]
Details on study design:
TEST SITE
- Area of exposure: 6 sq.cm of the dorsal area of the trunk
- % coverage: 6 sq.cm
- Type of wrap if used: impervious dressing with an adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: the patches were removed and the site of application was cleaned with lukewarm water after patch removal

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) : The treated sites were examined and scored at 60 minutes, 24,48 and 72 hours after application.

SCORING SYSTEM:
- Method of calculation: Draize method

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The test compound didnot produce any signs of irritation through out the observation period
Other effects:
The test compound did not produce any clinical signs of toxicity through out the study.

Any other information on results incl. tables

TABLE - 1

INDIVIDUAL ANIMAL DERMAL IRRITATION SCORES

Rabbit No.

Sex

INTACT SKIN

3 Min.

4 Hours

24 Hours

48 Hours

72 Hours

14 days

Erythema

Oedema

Erythema

Oedema

Erythema

Oedema

Erythema

Oedema

Erythema

Oedema

Erythema

Oedema

01

F

0

0

0

0

0

0

0

0

0

0

0

0

02

F

-

-

0

0

0

0

0

0

0

0

0

0

03

F

-

-

0

0

0

0

0

0

0

0

0

0

Total

0

0

0

0

0

0

0

0

0

0

0

0

Mean

0

0

0

0

0

0

0

0

0

0

0

0

Grand Total

0.00

Dermal Irritation Index: 0.0/4 = 0.0

CLINICAL SIGNS

 

SEX

ANIMAL NO.

Time (Min.)

Time (Hours)

Time (Day)

3

1

4

24

48

72

14

 

FEMALE

 

01

N

N

N

N

N

N

N

02

N

N

N

N

N

N

N

03

N

N

N

N

N

N

N

 

N: No Clinical Signs

C: Clinical Signs Observed

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
The Primary Irritation Index (PII) for the test chemical after 14 days of observation was 0.0. Also the test chemical did not produce any clinical signs of toxicity throughout the examination period of 14 days.
Hence, under the test conditions,the test chemical can be concluded to be not irritating to New Zealand White rabbit skin.
Executive summary:

A dermal irritation study was conducted on New Zealand white rabbits in accordance with OECD 404 to assess the irritation parameter of the test chemical. 3 female New Zealand White rabbits were used for the study. The animals were prepared 24 hrs prior to application of test product. The furs from the dorsal area of trunk of animals were removed with electric

clippers exposing an area measuring approximately 6 cm2 of body surface area of animal. The care was taken such that abrasion penetrated the Stratum corneum only and not dermis. 0.5 gm of the test compound was applied on a small area 6 square cms of the intact test site. Each site of application was covered with an impervious dressing which was secured with an adhesive tape. The animals were housed individually and restrained by the use of plastic collars. After patch removal [4 hours later] the unabsorbed test chemical was removed and the test site was washed with lukewarm water. The intact skin site of application was observed for erythema and edema at 1, 24,48 and 72 hours till 14 days after application and scored according to Draize method.

The Primary Irritation Index (PII) for the test chemical after 14 days of observation was 0.0. Also the test chemical did not produce any clinical signs of toxicity throughout the examination period of 14 days.

Hence, under the test conditions,the test chemical can be concluded  to be not irritating to New Zealand White rabbit skin.

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