Registration Dossier

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:
13 March 1989 to 25 September 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Cyclopentanone, 2-[(2R)-2-[(1R)-4-methyl-3-cyclohexen-1-yl]propyl]-, (2S)-rel-
Molecular formula:
C14H24O1
IUPAC Name:
Cyclopentanone, 2-[(2R)-2-[(1R)-4-methyl-3-cyclohexen-1-yl]propyl]-, (2S)-rel-
Constituent 2
Chemical structure
Reference substance name:
Cyclopentanone, 2-[(2S)-2-[(1R)-4-methyl-3-cyclohexen-1-yl]propyl]-, (2R)-rel-
Molecular formula:
C15H24O
IUPAC Name:
Cyclopentanone, 2-[(2S)-2-[(1R)-4-methyl-3-cyclohexen-1-yl]propyl]-, (2R)-rel-
Constituent 3
Chemical structure
Reference substance name:
Cyclopentanone, 2-[(2S)-2-[(1R)-4-methyl-3-cyclohexen-1-yl]propyl]-, (2S)-rel-
Molecular formula:
C15H24O
IUPAC Name:
Cyclopentanone, 2-[(2S)-2-[(1R)-4-methyl-3-cyclohexen-1-yl]propyl]-, (2S)-rel-
Constituent 4
Chemical structure
Reference substance name:
Cyclopentanone, 2-[(2R)-2-[(1R)-4-methyl-3-cyclohexen-1-yl]propyl]-, (2R)-rel-
Molecular formula:
C15H24O
IUPAC Name:
Cyclopentanone, 2-[(2R)-2-[(1R)-4-methyl-3-cyclohexen-1-yl]propyl]-, (2R)-rel-
Test material form:
liquid
Specific details on test material used for the study:
Substance name (as stated in the report): NECTARYL - LRG 1371
Identification for the study: 07683 D9 001
Description: colourless slightly viscous liquid
Batch: AS1241001

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
- Supplier: E.S.D. (Romans - 01400 Chatillon Sur Chalaronne - France)
- Age: adult
- Number and sex: 6 males
- Weight at the beginning of treatment 2.35 to 2.70 kg
- Cages: individually housed in polystyrene cages, with perforated flooring (interior dimensions 560 x 355 x 315 mm).
- Temperature: 17 to 21°C
- Humidity: 46 to 77 % R.H.
- Lighting: artificial, 12 hours out of 24 (photoperiod = 7h30 - 19h30)

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Remarks:
test substance as supplied
Controls:
no
Amount / concentration applied:
- Dose level : 0.5 ml per animal of the test substance as supplied.

Duration of treatment / exposure:
- Frequency: the test substance was applied once only.
- Length of exposure: 4 hours during which the animals were immobilized in restraining boxes.
- The dressings were then removed and the rabbits were returned to their individual cages.
Observation period:
Cutaneous examinations were performed 1, 24, 48 and 72 hours after removal of the dressing.
Number of animals:
a single group of 6 male rabbits

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 51422, 51440 and 51441
Time point:
24/48/72 h
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal: 51433
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal: 51629
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal: 51631
Time point:
24/48/72 h
Score:
1.33
Max. score:
2
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal: 51422, 51433, 51440, 51441, 51629 and 51631
Time point:
24/48/72 h
Score:
0
Max. score:
0

Any other information on results incl. tables

As no excess of substance was observed to the application area after removal of the semi-occlusive patch, no wiping was carried out.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
After a 4-hour local cutaneous application, under a semi-occlusive patch, the test substance as supplied can be considered as NON-IRRITANT.
Executive summary:

The Evaluate The Acute Primary Cutaneous Irritation And Corrosivity of NECTARYL In The Rabbit was performed according the OECD Guideline No. 404.

The test substance was applied as supplied and at the dose level of 0.5 ml per animal, under a semi-occlusive patch for 4 hours, to the intact skin of 6 Zealand hybrid albino male rabbits.

The cutaneous examinations were performed , for erythema and oedema, according to the Draize scale, 1, 24, 48 and 72hours after removal of the patch.

Mean values were calculated from the evaluation of the cutaneous lesions performed in all the rabbits examined at 24, 48 and 72 hours.

From the results obtained under the experimental conditions employed, application of this test substance to the rabbit' skin can be designated as: NON-IRRITANT

Categories Display