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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16 Dec - 23 Dec 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

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

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: EPA OPPTS 879.2700 (draft)

GLP compliance:

yes (incl. QA statement)

Remarks:

The Department of Health of the Government of the United Kingdom, UK

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

444-000-2

EC Name:

-

Cas Number:

647028-25-9

Molecular formula:

This is a UVCB so NA

IUPAC Name:

3-[3-(pentanoyloxy)-2,2-bis[(pentanoyloxy)methyl]propoxy]-2,2-bis[(pentanoyloxy)methyl]propyl pentanoate 3-{3-[(3,5,5-trimethylhexanoyl)oxy]-2,2-bis({[(3,5,5-trimethylhexanoyl)oxy]methyl})propoxy}-2,2-bis({[(3,5,5-trimethylhexanoyl)oxy]methyl})propyl 3,5,5-trimethylhexanoate

Details on test material:

- Name of test material (as cited in study report): only trade name given
- Physical state: straw coloured liquid
- Analytical purity: UVCB tested
- Storage condition of test material: at room temperature in darkness

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd., Moston Sandbach, Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.71-2.85 kg
- Housing: individual in suspended metal cages.
- Diet: STANRAB SQC Rabbit Diet (Special Diets Services Ltd., Witham, Essex, UK), ad libitum
- Water: tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-20
- Humidity (%): 51-60
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated sites of the same animal served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 mL
- Concentration: 100%

Duration of treatment / exposure:

4 h

Observation period:

14 days
Reading time points: 1, 24, 48 and 72 h and 7 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: dorsal flank
- Type of wrap if used: the test material was introduced under a 6.25 cm² cotton gauze patch and held in position with a strip of surgical adhesive tape (BLENDERM: approximately size 2.5 cm x 4.0 cm). To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset (TUBIGRIP).

REMOVAL OF TEST SUBSTANCE
- Washing: residual test material was removed by gentl swabbing with cotton wool soaked in 74% Industrial Methylated Spirits.
- 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 #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

Erythema: 2/3 animals showed slight erythema from 24 h up to 72 h being fully reversible within 7 days. In the remaining animal slight erythema was observed at the 24 and 48 h reading time point only.
Edema: No edema formation was apparent during the study period in any animal.

Other effects:

No other local or systemic effects were reported.

Any other information on results incl. tables

Table 1. Results of skin irritation study.

Observation time	Rabbit number and body weight (kg)
	#77 (2.83)		#79 (2.85)		#80 (2.71)
	Erythema	Edema	Erythema	Edema	Erythema	Edema
1 h	0	0	0	0	0	0
24 h	1	0	1	0	1	0
48 h	1	0	1	0	1	0
72 h	1	0	1	0	0	0
7 days	0	0	0	0	0	0
Mean value 24 + 48 + 72 h	1.00	0.00	1.00	0.00	0.67	0.00

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Conclusions:

CLP: not classified