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Toxicological information

Skin irritation / corrosion

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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

Constituent 1
Chemical structure
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:
2,2-dimethyl-1,3-propanediyl didecanoate

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

Resultsopen allclose all
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
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.

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