Dipentaerythritol hexaesters of 3,5,5-trimethylhexanoic, n-decanoic, n-heptanoic, and n-octanoic acids

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:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Remarks:

Composition of test substance unclear.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

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

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C5-10, esters with pentaerythritol

EC Number:

270-291-9

EC Name:

Fatty acids, C5-10, esters with pentaerythritol

Cas Number:

68424-31-7

Molecular formula:

C25H44O8 to C45H84O8

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 3.5 - 3.8 g

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

12 d
Reading time points: 30 - 60 min, 24, 48, 72 h, 7, 11 and 12 d

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm² on the shorn left flank (dorso-lumbar region)

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 scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #15

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 12 d

Results 2

Irritation parameter:

erythema score

Basis:

animal: #16

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 11 d

Results 3

Irritation parameter:

erythema score

Basis:

animal: #17

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 7 d

Results 4

Irritation parameter:

edema score

Basis:

animal: #15

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 d

Results 5

Irritation parameter:

edema score

Basis:

animal: #16

Time point:

24/48/72 h

Score:

1.7

Max. score:

4

Reversibility:

fully reversible within: 7 d

Results 6

Irritation parameter:

edema score

Basis:

animal: #17

Time point:

24/48/72 h

Score:

1.7

Max. score:

4

Reversibility:

fully reversible within: 7 d

Irritant / corrosive response data:

Following the single 4-hour application, very slight to well-defined erythema and very slight to slight oedema were observed in all animals. This regressed and no signs of erythema or oedema were evident 11 or 12 days after application. Slight desquamation at the application site of one animal was observed 7 days after application.

Any other information on results incl. tables

Table 1: Erythema score

Animal Number	1 h	24 h	48 h	72 h	7 days	11 days	12 days	Mean Score (24 -72 h)
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

 

Table 2:Edema Score

Animal Number	1 h	24 h	48 h	72 h	7 days	11 days	12 days	Mean Score (24 - 72 h)
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

Applicant's summary and conclusion

Interpretation of results:

other: inconclusive

Remarks:

Criteria used for interpretation of results: EU