2,5,6-trimethylcyclohex-2-en-1-one

Skin irritation / corrosion

Administrative data

Endpoint:

skin 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.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

1969

Report date:

1969

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

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

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,5,6-trimethylcyclohex-2-en-1-one

EC Number:

243-473-0

EC Name:

2,5,6-trimethylcyclohex-2-en-1-one

Cas Number:

20030-30-2

Molecular formula:

C9H14O

IUPAC Name:

2,5,6-trimethylcyclohex-2-en-1-one

Details on test material:

- Name of test material (as cited in study report): 2,5,6-Trimethyl-2-2cyclohexen-1-on
- Analytical purity: 98 - 99 %

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.88 and 3.17 kg

Test system

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

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:

After exposure (only 1, 5, 15 min.), 24 hrs, 48 h, 5 days, 6 days and 8 days

Number of animals:

2 female

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm of back skin
- Type of wrap if used: cotton pad (seize: 2.5 cm x 2.5 cm) saturated with the undiluted test substance (ca. 0.5 ml)


REMOVAL OF TEST SUBSTANCE
- Washing (if done): 50% Lutrol (polyethylenglycol) dilution in water
- Time after start of exposure: 1, 5, 15 min and 20 h


SCORING SYSTEM:
Erythema and edema were scored according to the below described system:
Although the results in the report were originally not given as Draize scores the data can be transferred into the Draize scoring system (in brackets). (+) = none - negligible effect (0)
+ = slight effect (1)
++ = moderate effect (2)
+++ = severe effect (>= 3)
N = necrosis

Results and discussion

In vivo

Results

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24-72 h

Score:

2.4

Max. score:

3

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: exposure period: 20h

Any other information on results incl. tables

Results:

Animal 1: 2.88 kg; animal 2: 3.17 kg

Readings	Animal	Exposure period: 1 min			Exposure period: 5 min			Exposure period: 15 min			Exposure period: 20 h
		Erythema	Edema	Additional findings	Erythema	Edema	Additional findings	Erythema	Edema	Additional findings	Erythema	Edema	Additional findings
1h	1	2	0		2	0		2	0		3	0
	2	2	0		2	0		2	0			0
24 h	1	2	0		2	0		3	0		3	0
	2	2	0		2	0		2	0		3	0
48 h	1	1	0		2	0		3	0		2	0
	2	2	0		2	0		2	0		2	0
72 h	1	1	0		1	0		2	0			0	D
	2	1	0		1	0		1	0		2	0
96 h	1	0	0		0	0		0	0	D		0	D
	2	1	0		1	0		1	0		1	0	D
8 d	1	0	0		0	0		0	0	D		0	D
	2	0	0	D	0	0	D	0	0	D	0	0	D
Mean 24 - 72 h	1	1.3	0		1.7	0		2.7	0		2.5	0
	2	1.7	0		1.7	0		1.7	0		2.3	0
Mean		1.5	0		1.7	0		2.2	0		2.4

D: desquamation

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Due to desquamation at the end of observation period in both animals after the 15 min application and erythema score of >2 within the 24 to 72 h period after the application for 15 min, TMCH needs to be classified irritant to skin.