Dodecanoic acid, ester with 1,2,3-propanetriol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

25 Feb - 04 Mar 1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

lack of test material details, occlusive dressing

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

RL 79/831/EWG

Deviations:

yes

Remarks:

lack of test material details, occlusive dressing

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

Council Regulation (EC) No 440/2008 of 30 May 2008

Deviations:

yes

Remarks:

lack of test material details, occlusive dressing

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Glycerides, C16-18 and C18-hydroxy mono- and di-

EC Number:

295-191-2

EC Name:

Glycerides, C16-18 and C18-hydroxy mono- and di-

Cas Number:

91845-19-1

Molecular formula:

C51H98O6; C57H110O6 C57H110O9; C57H110O12

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Thomae, Biberach, Germany
- Weight at study initiation: 3738 g
- Housing: animals were housed individually in cages (Heinkel, Kuchen, Germany)
- Diet: Altromin-Haltungsdiät 2023 (Altromin GmbH, Lage, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 1 month

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21
- Humidity (%): 45-50
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

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 g

Duration of treatment / exposure:

4 h

Observation period:

14 days
Reading time points: 1, 24, 48 and 72 h and 6 days

Number of animals:

5

Details on study design:

TEST SITE
- Area of exposure: 6.25 cm² on the dorsal area of the trunk
- Type of wrap if used: The treated skin was covered with a gauze patch and covered with plastic strip and hold in place with an adhesive plaster and an acrylastic bandage.

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:

0.33

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 4

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 6 days

Results 5

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 6

Irritation parameter:

edema score

Basis:

mean

Remarks:

out of all 5 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

No edema formation was observed in any animal at any reading time point during the study period. 1/5 animals showed a slight erythema at the 24 h reading time point and one animal at the 48 h reading time point which were both fully reversible within 48 and 72 h, respectively. 1/5 animals showed a well defined erythema at the 24 h reading time point, after 48 h only a slight erythema was visible and was fully reversible within 6 days.

Other effects:

No effects on bodywheight were observed.

Any other information on results incl. tables

Table 1. Results of skin irritation study.

Observation time	Rabbit no.
	1		2		3		4		5
	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema
1 h	0	0	0	0	0	0	0	0	0	0
24 h	0	0	0	0	1	0	2	0	0	0
48 h	1	0	0	0	0	0	1	0	0	0
72 h	0	0	0	0	0	0	1	0	0	0
Mean value 24 + 48 + 72 h	0.33	0.00	0.00	0.00	0.33	0.00	1.33	0.00	0.00	0.00
Mean value 24 + 48 + 72 h all animals	0.40	0.00

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