6,10,14-trimethylpentadecan-2-one

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

6,10,14-trimethylpentadecan-2-one

EC Number:

207-950-7

EC Name:

6,10,14-trimethylpentadecan-2-one

Cas Number:

502-69-2

Molecular formula:

C18H36O

IUPAC Name:

6,10,14-trimethylpentadecan-2-one

Details on test material:

Purity: unknown

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Savo. med. Versuchstierzuchten GmbH, 7964 Kisslegg/Allgäu, Germany
- Weight at study initiation: 2.11 kg (2.06, 2.06 and 2.21 kg)
- Housing: single in cage made of stainless steel with wire mesh walk floors, floor area: 40 cm * 51 cm
- Bedding: no bedding in the cages, saw-dust in the waste trays
- Identification: ear tattoo (= animal number)
- Diet: KLIBA 341, 4 mm; Firma Klingentalmühle AG, CH-4303 Kaiseraugst, Switzerland; about 130 g / animal / day
- Water: about 250 ml tap water / animal / day
- Acclimation period: at least 8 days before the beginning of the study; same housing conditions as during the study
- clipping of the fur: at least 15 hours before the beginning of the study


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin sites of the same animal

Amount / concentration applied:

undiluted
0.5 ml
6.25 cm²

Duration of treatment / exposure:

4 hour(s)

Observation period:

8 days

Number of animals:

3 (1 male, 2 females)

Details on study design:

- application: 0.5 ml of the undiluted test substance to the test patch (2.5 cm * 2.5 cm)
- site: upper third of the back or flanks
- dressing: test patches were secured in position with a porous dressing (four layers of absorbent gauze + porous bandage)
- removal of the test substance: at the end of the exposure period with lutrol and lutrol/water (1:1)
- readings: 30-60 min after removal of the test patches and 24 h, 48 h, 72 h and 8 d after the beginning of application
- negative control: untreated skin sites of the same animal

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Executive summary:

animals 1 and 3: female, animal 2: male

	animal	erythema	edema	symptoms
4 h	1	2	1
	2	2	1
	3	2	1
24 h	1	2	0
	2	2	0	erythema extending beyond the area of exposure
	3	2	0
48 h	1	2	0	scaling
	2	2	0	erythema extending beyond the area of exposure
	3	2	0
72 h	1	2	0	scaling
	2	2	0	erythema and scaling extending beyond the area of exposure
	3	2	0
8 d	1	0	0	scaling
	2	0	0
	3	0	0	scaling
mean (24-72 h)	1	2	0
	2	2	0
	3	2	0
mean (24-72 h)	1-3	2	0

evaluation:

0 = none

1 = very slight

2 = well-definded

3 = moderate to severe

4 = severe to very severe

calculation of the mean according to 83 / 467 / EEC criteria: only the readings of 24, 48 and 72 hours are used