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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
Organization for Economic Cooperation and Development (1981) OECD Short-Term and LongvTerm Toxicology Groups. Final Report: Acute Dermal Irritation & Corrosion
Cater, R.O. & Griffith, J.F., (1965). Experimental Basis for the Realistic Assessment of Safety of Topical Agent. Toxicol. Appl. Pharm. 1., 60-75.
Deviations:
not specified
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
A mixture mainly based on: 2,3-dihydro-6-(2-hydroxy-2-methyl-1-oxopropyl)-1,1,3-trimethyl-3-[4-(2-hydroxy-2-methyl-1-oxopropyl)phenyl]-1H-indene; 2,3-dihydro-5-(2-hydroxy-2-methyl-1-oxopropyl)-1,1,3-trimethyl-3-[4-(2-hydroxy-2-methyl-1-oxopropyl)phenyl]-1H-indene
EC Number:
402-990-3
EC Name:
A mixture mainly based on: 2,3-dihydro-6-(2-hydroxy-2-methyl-1-oxopropyl)-1,1,3-trimethyl-3-[4-(2-hydroxy-2-methyl-1-oxopropyl)phenyl]-1H-indene; 2,3-dihydro-5-(2-hydroxy-2-methyl-1-oxopropyl)-1,1,3-trimethyl-3-[4-(2-hydroxy-2-methyl-1-oxopropyl)phenyl]-1H-indene
Cas Number:
163702-01-0
Molecular formula:
C26H32O4
IUPAC Name:
Reaction mass of 2-hydroxy-1-{3-[4-(2-hydroxy-2-methylpropanoyl)phenyl]-1,1,3-trimethyl-2,3-dihydro-1H-inden-5-yl}-2-methylpropan-1-one and 2-hydroxy-1-{1-[4-(2-hydroxy-2-methylpropanoyl)phenyl]-1,3,3-trimethyl-2,3-dihydro-1H-inden-5-yl}-2-methylpropan-1-one
Test material form:
solid
Remarks:
Form specified in RSS.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Animal origin:
"Padre Antonio" breeding center, Mariano Comense - CO— Italy

Weight:
2.000 - 3.000 kg

Housing:
Environmental conditions
Housing overpressure environment compared to the external atmosphere, maintained at following conditions:
Temperature: 0 °C ± 3 °C
Humidity: 55% ± 15% Relative humidity
Air parts: At least eight per hour

Cages:
Model 1472 stainless steel cages of the company "Tecuiplast" Gazzada (Varese). Cycle of 10 seconds automatic washing every 60 minutes.

Food supply:
Complete pelletized diet

Acgua:
"Ad libitum". Municipal water supply system filtered with Seitz filter, chemically and bacteriologically analyzed twice a year.

Quarantine:
One week

Preparation of animals:
Animal health conditions are check 24 hours before the test starts. The back of the animals is shaved by doing be careful not to damage the skin. Only animals with intact skin are used.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
1.0 g/animal
Duration of treatment / exposure:
24 hours
Observation period:
After 24 hours the gauze is removed and the skin reactions are immediately evaluated. The evaluation is then repeated 72 hours after application. The skin reactions are re-evaluated after five and seven days to determine the reversibility or irreversibility of the lesions observed.
Number of animals:
6
Details on study design:
Administration:

The back and sides of the animals are shaved. Two areas about 10 cm apart. are designated for affixing the material in question.

The fiance area is abraded by practicing with the tip of a needle three light epidermal incisions along parallel lines, of about 3 cm. and distant 0.5 cm.

The engravings are of exclusive interest the stratum corneum and are not so deep as to cause bleeding. The material under examination is absorbed on two surgical gauze tablets (2.5x2.5 cm) consisting of 12 layers.

The two tablets are fixed to the sides of the animal using a hypoallergenic adhesive tape (Blenderm BM). The entire trunk of the animal is further protected by an elastic bandage (Acrylastic Beyersdorf AG Hamburg).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
Intact and scarified
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Remarks:
Intact and scarified
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Remarks:
Intact and scarified
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Remarks:
Intact and scarified
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Remarks:
Intact and scarified
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Remarks:
Intact and scarified
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
Intact and scarified
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
Intact and scarified
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
Intact and scarified
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
Intact and scarified
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
Intact and scarified
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
Intact and scarified
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance does not meet the criteria for classification under CLP.
Executive summary:

In this guideline study, the test substance (EC 402-990-3) was found not to meet the criteria for classification as a skin irritant/corrosive under CLP.