2,2-dimethyl-1,3-propanediyl didecanoate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

05 - 08 Sep 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

The analytical purity of the test substance was not specified.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted in 2015

Deviations:

yes

Remarks:

occlusive wrapping used

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,2-dimethyl-1,3-propanediyl didecanoate

EC Number:

248-688-3

EC Name:

2,2-dimethyl-1,3-propanediyl didecanoate

Cas Number:

27841-06-1

Molecular formula:

C25H48O4

IUPAC Name:

3-(decanoyloxy)-2,2-dimethylpropyl decanoate

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hare-Marland, Hewitt, USA
- Age at study initiation: adult animals
- Housing: animals were housed individually in cages
- Diet: Purina Certified Rabbit RationR, ad libitum
- Water: fresh tap water, ad libitum (analyses were performed)
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: not required, untreated sites of the same animal served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 mL /site

Duration of treatment / exposure:

4 h

Observation period:

3 days
Reading time points: 0.5 - 1, 24, 48 and 72 h

Number of animals:

3 males and 3 females

Details on study design:

TEST SITE
- Type of wrap: gauze patches were applied to each site. The trunk of the animals was then covered with a rubber dam and wrappped with an elastic bandage to retard evaporation.

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

24/48/72 h

Score:

0.11

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Irritant / corrosive response data:

2/6 animals (1 female and 1 male) showed very slight erythema (score 1) after 30 - 60 min, which was fully reversible after 24 h in the male and after 48 h in the female. In 1 other male a very slight erythema was observed at the 24-hour reading time point, which was reversed until the next reading at 48 h.

Any other information on results incl. tables

Table 1: Results of skin irritation study

Rabbit	Male						Female
	1		2		3		4		5		6
Observation time [h]	E	O	E	O	E	O	E	O	E	O	E	O
0.5 - 1	1	0	0	0	0	0	0	0	0	0	1	0
24	0	0	1	0	0	0	0	0	0	0	1	0
48	0	0	0	0	0	0	0	0	0	0	0	0
72	0	0	0	0	0	0	0	0	0	0	0	0
Mean value (24 / 48/ 72 h)	0	0	0.33	0	0	0	0	0	0	0	0.33	0
Mean value erythema (all 6 animals; 24 / 48/ 72 h)	0.11
Mean value oedema (all 6 animals; 24 / 48/ 72 h)	0.00

E = erythema

O = oedema

The mean is calculated only for the values 24 -72 h.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.