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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
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

Reference
Name:
Unnamed
Type:
Constituent
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 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

Resultsopen allclose all
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
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24h and 72 h
Score:
1.33
Max. score:
4
Reversibility:
not reversible
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.