3-aminomethyl-3,5,5-trimethylcyclohexan-1-ol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1980-08

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Principles of method if other than guideline:

Method: U.S. Consumer Product Safety Commission, Code of Federal Regulations,  Title 16, Section 1500.41; Evaluation with Draize scores.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-aminomethyl-3,5,5-trimethylcyclohexan-1-ol

EC Number:

239-717-0

EC Name:

3-aminomethyl-3,5,5-trimethylcyclohexan-1-ol

Cas Number:

15647-11-7

Molecular formula:

C10H21NO

IUPAC Name:

3-(aminomethyl)-3,5,5-trimethylcyclohexan-1-ol

Test material form:

liquid: viscous

Details on test material:

3-aminomethyl-3,5,5-trimethylcyclohexan-1-ol

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS: 
- Strain: New Zealand white
- Source: J. Scheele, Büderich/Westf., 4760 Werl

Housing conditions:
- Room temperature: 20°C (+/- 1°C);
- Light: 12 hours/day;
- Access to drinking water: ad libitum;
- Diet: K4 diet for rabbits (Ssniff; Soest)

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved, intact and scarified

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

undiluted
Amound applied: 0.5 ml

Duration of treatment / exposure:

24 hour(s)

Observation period:

Postexposure period: 14 days

Number of animals:

6

Details on study design:

ADMINISTRATION: 
- Volume administered or concentration: 0.5 ml
- Post dose observation period: 48 hours
- Application to both intact and scarified skin

EXAMINATIONS: 24 and 72 hours

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 h and 72 h

Score:

2.25

Max. score:

4

Reversibility:

not reversible

Remarks:

necrosis, strong incrustion

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24h and 72 h

Score:

1.33

Max. score:

4

Reversibility:

not reversible

Results 3

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24 h and 72 h

Score:

3.6

Max. score:

8

Irritant / corrosive response data:

AVERAGE SCORE
- Erythema: 2.25
- Edema: 1.33
24 hours after application all rabbits showed necrosis and slight to moderate oedem, 72 hours after application all rabbits showed strong incrustions

Other effects:

no

Any other information on results incl. tables

no further remarks

Applicant's summary and conclusion

Conclusions:

Under the present conditions of this study necrosis, strong incrustions and slight to moderate oedema were observed after application of 0.5 ml itest tem (24 hrs exposure) to both intact and sacrified skin of rabbits. Therfore, test item is strong irritating to skin.

Executive summary:

The acute skin irritation properties of the test item were estimated in a modified Draize test. A dose of 0.5 ml test item per animal was applied to both intact and sacrified skin of 6 rabbits under occlusive conditions. After a 24 -hours exposure period the patch was removed and skin irritation was assessed using Draize scale. The average scores at 24 and 72 hours after patch removal are as follows:

- Erythema: 2.25

- Edema: 1.33

24 hours after application all rabbits showed necrosis and slight to moderate oedem, 72 hours after application all rabbits showed strong incrustions.

Therfore, test item is strong  irritating to skin.