6-methylhept-5-en-2-one

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions.

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

e.g. animal number, test sample application duration, tested under occlusion

Principles of method if other than guideline:

Study was performed acc. internal BASF method, which was in part similiar to OECD 404.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

6-methylhept-5-en-2-one

EC Number:

203-816-7

EC Name:

6-methylhept-5-en-2-one

Cas Number:

110-93-0

Molecular formula:

C8H14O

IUPAC Name:

6-methylhept-5-en-2-one

Details on test material:

- Name of test material (as cited in study report): 6-Methyl-5-hepten-2-one,
- Analytical purity: 98 %
- pH = 5.6

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: M. Gaukler, Offenbach, Germany)
- Weight at study initiation: about 2.9 kg

Test system

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ca. 0.5 ml
- Concentration (if solution): 100%

Duration of treatment / exposure:

1 min, 5 min, 15 min, 20 h

Observation period:

24 hrs, 48 h, 5 days, 6 days and 8 days after exposure

Number of animals:

total 4; 2 male, 2 female

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm of back skin

REMOVAL OF TEST SUBSTANCE
- Washing (if done): 50% Lutrol (polyethylenglycol) dilution in water

SCORING SYSTEM:
BASF scoring system converted to OECD Draize scores

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24 h

Score:

1

Reversibility:

fully reversible within: 48 h

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24 h

Score:

1

Reversibility:

fully reversible within: 5 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

48 h

Score:

0

Results 4

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

48 h

Score:

1

Reversibility:

fully reversible within: 5 days

Results 5

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

72 h

Score:

0

Remarks on result:

other: third time point 5 days (instead of 72 h)

Results 6

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

72 h

Score:

0

Remarks on result:

other: third time point 5 days (instead of 72 h)

Results 7

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: third time point 5 days (instead of 72 h)

Results 8

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: third time point 5 days (instead of 72 h)

Irritant / corrosive response data:

Please refer to the table.

Any other information on results incl. tables

Application: 20 hours
Readings	Animal	Erythema	Edema	Further findings
24h	1	1	0
	2	1	0
48h	1	0	0
	2	1	0
5 d	1	0	0
	2	0	0	desquamation
6 d	1	0	0
	2	0	0	desquamation
8d	1	0	0
	2	0	0	desquamation

No skin reactions were observed after test substance application for 1, 5, 15 min. 2 Additional animals were used for test substance application on ears only (not considered relevant for assessment).

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Occlusive application of 6-methyl-hept-5-en-2-one for 20 hrs to rabbit skin Iead to slight signs of irritation which were almost reversible within 48 hrs. Therefore, the present data on skin irritation do not fulfill the criteria laid down in Annex I of the CLP Regulation (1272/2008/EC) and the substance does not need to be classified for skin irritation.

Executive summary:

An occlusive skin irritation/corrosion study was performed according to a BASF study method, as no OECD test guideline was in place at the time. The used method is similar to OECD Guideline 404 with, but has differences in animal number, test sample application duration and was tested under occlusion.

Four animals (2 male/2 female) were exposed 0.5 ml 100% substance by occlusive application for 1 min, 5 min, 15 min, and 20 h. Animals were observed for 24 hrs, 48 h, 5 days, 6 days and 8 days after exposure. Only occlusive application of 6-methyl-hept-5-en-2-one for 20 h to rabbit skin, representing a worst case exposure compared to current testing conditions, lead to slight signs of irritation which were almost reversible within 48 hrs. Therefore, the present data on skin irritation do not fulfill the criteria laid down in Annex I of the CLP Regulation (1272/2008/EC) and the substance does not need to be classified for skin irritation.