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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:
14 September - 13 December 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

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 (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
(E)-cyclohexadec-5-enone
Cas Number:
35951-24-7
Molecular formula:
C16H28O
IUPAC Name:
(E)-cyclohexadec-5-enone
Constituent 2
Chemical structure
Reference substance name:
(Z)-cyclohexadec-5-enone
Cas Number:
21944-95-6
Molecular formula:
C16H28O
IUPAC Name:
(Z)-cyclohexadec-5-enone
Specific details on test material used for the study:
Name (as stated in the report): Velvione
Batch: 9000319175
Expiration date: August 11, 2001

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Sex: 1 male and 2 females
Age at the start of the treatment: 14 weeks (Males) and 15 weeks (Females)
Identification: By unique cage number and corresponding ear number
Acclimatization: Under laboratory conditions after health examination. Only anmials without any visual sign of illness were used for the study.
Allocation: Male No. 91 and Females 92 - 93
Accomodation: Individually in stainless stell cages equipped with feed hoppers, drinking water bowls, with wood and haysticks for gnawing.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
As a liquid, 0.5 ml (per animal) was measured with a seringe and applied undiluted as it was supplied by the Sponsor.
Duration of treatment / exposure:
The duration of the treatement was 4 hours.
Observation period:
Daily from the delivery of animals to the termination of the test.
Number of animals:
1 male and 2 females
Details on study design:
Four days before treatment the left flank was clipped with an electric clipper, exposing an area of approximately 100 cm2 (10 cm x 10 cm). The skin of animals was examined approximately 24 hours before treatment, and regrown was again clipped.
On day of the treatment, 0.5 ml of VELVIONE were put on a surgical gauze patch (ca 2.5 cm x 2.5 cm). This gauze patch was applied to approximately 6 cm2 of the intact skin of the clipped area. The patch was covered with a semi occlusive dressing. The dressing was wrapped around the abdomen and anchored with tape. The duration of the treatement was 4 hours. The the dressing was removed and the skin was flushed with lukewarn tap water to clean application site so that any reactions (erythema) were clearly visible at that time.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 91
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: NA
Irritation parameter:
erythema score
Basis:
animal: 92 and 93
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: 91, 92 and 93
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: NA
Irritant / corrosive response data:
The dermal exposure to VELVIONE caused a very slight erythema at the 1-hour reading in both females which persisted until 72 hour examinations. All skin reactions desappeared 7 days after treatment.
No irriversible alteration of the treated skin were observed nor were corrosive effects evident.
Other effects:
No clinical signs of systemic toxicity were observed in the animals during the test and observation period. No mortality occured.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
VELVIONE is therefore considered to be "non-irritating" to rabbit skin. Hence, VELVIONE does not met the criteria for skin irritation classication according the CLP Regulation (EC) No. 1272/2008.
Executive summary:

VELVIONE was tested under the test conditions decribed below for evaluation of the skin irritation potential according to the OECD guideline 404.

Four days before treatment the left flank was clipped with an electric clipper, exposing an area of approximately 100 cm2 (10 cm x 10 cm). The skin of animals was examined approximately 24 hours before treatment, and regrown was again clipped.

On day of the treatment, 0.5 ml of VELVIONE were put on a surgical gauze patch (ca 2.5 cm x 2.5 cm). This gauze patch was applied to approximately 6 cm2 of the intact skin of the clipped area. The patch was covered with a semi occlusive dressing. The dressing was wrapped around the abdomen and anchored with tape. The duration of the treatement was 4 hours. The the dressing was removed and the skin was flushed with lukewarn tap water to clean application site so that any reactions (erythema) were clearly visible at that time.

Under the conditions of this test, VELVIONE is considered to be "non-irritating" to rabbit skin. Hence, VELVIONE does not met the criteria for skin irritation classication according the CLP Regulation (EC) No. 1272/2008.