2,2-bis[[(1-oxopentyl)oxy]methyl]propane-1,3-diyl divalerate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study with acceptable restrictions Lack of details in study documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

1991

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Lack of details in study documentation

Principles of method if other than guideline:

Application of 0.5 ml to an area of approx. 2.5 cm x 2.5 cm.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

68424-31-7

Cas Number:

68424-31-7

IUPAC Name:

68424-31-7

Constituent 2

Reference substance name:

Fatty acids, C5-10, esters with pentaerythritol

EC Number:

270-291-9

EC Name:

Fatty acids, C5-10, esters with pentaerythritol

IUPAC Name:

270-291-9

Constituent 3

Reference substance name:

Fatty acids, C5-10, esters with pentaerythritol

IUPAC Name:

Fatty acids, C5-10, esters with pentaerythritol

Details on test material:

No Data

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

No Data

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

not specified

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml
- Concentration (if solution): No Data

Duration of treatment / exposure:

4 h

Observation period:

12 d

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm² on the shorn left flank (dorso-lumbar region)
- Type of wrap if used: semi-occlusive


REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water upon the removal of the dressing
- Time after start of exposure:4 h


SCORING SYSTEM: Draize scale

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of animal #15 and readings at

Time point:

other: 24 h, 48 h and 72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 12 d

Results 2

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of animal #16 and readings at

Time point:

other: 24 h, 48 h and 72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 11 d

Results 3

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of animal #17 and readings at

Time point:

other: 24 h, 48 h and 72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 7 d

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

of animal #15 and readings at

Time point:

other: 24 h, 48 h and 72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 d

Results 5

Irritation parameter:

edema score

Basis:

mean

Remarks:

of animal #16 and readings at

Time point:

other: 24 h, 48 h and 72 h

Score:

1.7

Max. score:

4

Reversibility:

fully reversible within: 7 d

Results 6

Irritation parameter:

edema score

Basis:

mean

Remarks:

of animal #17 and readings at

Time point:

other: 24 h, 48 h and 72 h

Score:

1.7

Max. score:

4

Reversibility:

fully reversible within: 7 d

Irritant / corrosive response data:

Following the single 4-hour application, a very slight to well-defined erythema and very slight to slight oedema were observed. This regressed and no signs of erythema or oedema were evident eleven or twelve days after application. Slight desquamation at the application site of one animal was observed seven days after application.

Any other information on results incl. tables

Erythema score

Animal Number	1 h	24 h	48 h	72 h	7 days	11 days	12 days	Mean Score
15	2	-	1	1	1		0	1.0
16	2	2	1	1	1	0		1.3
17	1	2	1	1	0			1.3

 

Edema Score

Animal Number	1 h	24 h	48 h	72 h	7 days	11 days	12 days	Mean Score
15	1	-	1	1	0		0	1.0
16	2	2	2	1	0	0		1.7
17	1	2	2	1	0			1.7

Conclusion: The test substance does not have to be classified as irritant to the skin according to the criteria of the DSD and CLP regulations under the conditions of this study.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU