tert-butyl 3-oxobutanoate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1985-02-26 - 1985-03-01

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was conducted according to OECD guideline and GLP.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

Principles of method if other than guideline:

Not applicable.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Acetessigsäure-tert.butylester

IUPAC Name:

Acetessigsäure-tert.butylester

Constituent 2

Reference substance name:

t-Butyl-acetoacetate

IUPAC Name:

t-Butyl-acetoacetate

Test material form:

other: liquid

Details on test material:

Product no.: IMAH 005
Appearance: liquid, clear
Storage: at 22°C, under the hood, in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Duration of treatment / exposure:

4 hours

Observation period:

30 - 60 min and 24, 48 and 72 hours after removal of the patch.

Number of animals:

3 albino rabbits were employed for this study.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 1, 24, 48, 72 hours

Score:

0.7

Max. score:

2

Reversibility:

fully reversible within: 72 hours

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 1, 24, 48, 72 hours

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 1, 24, 48, 72 hours

Score:

0.7

Max. score:

2

Reversibility:

fully reversible within: 72 hours

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 1, 24, 48, 72 hours

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

other: all three animals

Any other information on results incl. tables

Exposure: 4 hours, semi-occlusive, intact skin

Skin reaction	Reading (hours)	Individual scores – rabbit no.
		1	2	3
Erythema/Eschar	1 24* 48* 72*	2 1 1 0	1 1 0 0	0 1 1 0
Total of *		2	1	2
Mean values of *		0.7	0.3	0.7
Oedema	1 24* 48* 72*	0 0 0 0	0 0 0 0	0 0 0 0
Total of *		0	0	0
Mean values of *		0.0	0.0	0.0

 

Sum of 1, 24 and 48-hour readings (S): 8

Irritation index (S/9): 0.9

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item will be not classified as skin irritant to the rabbit skin according to Regulation (EC) 1272/2008.

Executive summary:

The study was performed 1985, according to OECD Guideline and amended in year 1993 (Addendum to Lonza Report No. 2005).

The test item will be not classified as skin irritant to the rabbit skin according to Regulation (EC) 1272/2008.