6-methylhept-5-en-2-one

Endpoint summary

Description of key information

Skin irritation (similar to OECD 404): not irritating

Eye irritation (similar to OECD 405): not irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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.

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

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

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

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24 h

Score:

1

Reversibility:

fully reversible within: 48 h

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24 h

Score:

1

Reversibility:

fully reversible within: 5 days

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

48 h

Score:

0

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

48 h

Score:

1

Reversibility:

fully reversible within: 5 days

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)

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)

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)

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.

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).

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

e.g. number of test animals

Principles of method if other than guideline:

Study was performed acc. internal BASF method, which was in part equivalent to OECD 405

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

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

Vehicle:

unchanged (no vehicle)

Controls:

other: left eye of same animal treated with 0.9% saline solution

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.05 ml
- Concentration (if solution): 100%

Observation period (in vivo):

1 hr, 24 hrs, 48 hrs, 72 hrs, d4, d7 and d8 after application

Number of animals or in vitro replicates:

1 male and 1 female

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing

SCORING SYSTEM: BASF Scoring system converted to OECID Draize scores

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.66

Max. score:

1

Reversibility:

fully reversible within: 72 h

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 8 days

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 48 h

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: at 1 h: 2

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: at 1 h: 1

Irritant / corrosive response data:

Please refer to the table.

		Cornea		Iris	Conjunctiva
Readings	Animal	Opacity	Area involved		Redness	Swelling	Discharge	Further findings
1h	1	1	0	0	1	2	0
	2	0	0	0	1	1	0
24h	1	1	0	0	1	0	0
	2	0	0	0	1	0	0
48h	1	1	0	0	1	0	0
	2	0	0	0	0	0	0
72h	1	0	0	0	1	0	0
	2	0	0	0	0	0	0
8d	1	0	0	0	0	0	0
	2	0	0	0	0	0	0

Interpretation of results:

GHS criteria not met

Conclusions:

Application of 6-methyl-hept-5-en-2-one to rabbit eye shows a slight irritating potential to the eyes of rabbits, all effects are completely reversible. Based on this result, the substance does not need to be classified for eye irritation in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).

Executive summary:

An eye irritation study was performed according to a BASF method as no OECD test guideline was in place at the time. The study was similar to OECD Guideline 405 (Acute Eye Irritation / Corrosion) with a difference in  animal number. Two animals (1 male/1 female) were exposed to 50 µl 100% substance, which was not washed out. Animals were observed for 1 hr, 24 hrs, 72 hrs and until 8 days after application. The application of 6-methyl-hept-5-en-2-one shows slight irritating potential to the eyes of rabbits, but all effects are completely reversible. Under the conditions of the test, the presented data on eye irritation toxicity 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 eye irritation.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

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, leads to slight signs of irritation which were almost reversible within 48 hrs. In conclusion, the substance is not considered to cause skin irritation.

Eye irritation

An eye irritation study was performed according to a BASF method as no OECD test guideline was in place at the time. The study was similar to OECD Guideline 405 (Acute Eye Irritation / Corrosion) with a difference in  animal number. Two animals (1 male/1 female) were exposed to 50 µl 100% substance, which was not washed out. Animals were observed for 1 hr, 24 hrs, 72 hrs and until 8 days after application. The application of 6-methyl-hept-5-en-2-one shows slight irritating potential to the eyes of rabbits, but all effects are completely reversible. In conclusion, the substance is not considered to cause eye irritation.

Justification for classification or non-classification

Based on the available data, Methylheptenone does not need to be classified for skin and eye irritation in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).