6-methylhept-5-en-2-one

Eye irritation

Administrative data

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.

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 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

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 %

Test animals / tissue source

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

Test system

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

Results and discussion

In vivo

Results

Results 1

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

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Results 3

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

Results 4

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

Results 5

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Results 6

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Results 7

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: at 1 h: 2

Results 8

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.

Any other information on results incl. tables

		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

Applicant's summary and conclusion

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.