Dodecanoic acid, ester with oxybis[propanediol]

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

Study period:

01 Feb - 08- Feb 1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP - Guideline study, tested with the source substance 143-07-7. According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

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

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Lauric acid

EC Number:

205-582-1

EC Name:

Lauric acid

Cas Number:

143-07-7

IUPAC Name:

lauric acid

Details on test material:

- Name of test material (as cited in study report): only trade name given
- Physical state: solid
- Analytical purity: no data
- Storage condition of test material: at room temperature in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: 13 weeks
- Weight at study initiation: 2427 - 2547 g
- Housing: individually in cages with perforated floors equipped with an automatic drinking system (ITL, Bergen, The Netherlands).
- Diet: standard laboratory rabbit diet (LKK-20, pellet diameter 4 mm, Hope Farms, Woerden, The Netherlands); approx. 100 g/day.
- Water: tap-water diluted with decalcified water, ad libitium
- Acclimation period: at least five days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70
- Air changes (per hr): air-conditioned with 7.5 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

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

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

4 h

Observation period:

8 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: 10 cm x 10 cm
- Type of wrap if used: The dressing was wrapped around the abdomen and secured with an elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: The remaining test substance was removed with a dry tissue and with a tissue moistened with tap water.
- 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:

mean

Remarks:

out of all 3 animals

Time point:

other: mean over 24, 48 and 72 h

Score:

0.4

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

Skin irritation consisted of very slight erythema. The skin irritation was reversible in one animal within 24 h and within 48 h in the second anima and in the third animal within 7 days after exposure.
No edema formation or corrosive effect was evident on the skin in any animal during the study period.

Other effects:

No systemic toxicity were observed in the animals during the study period and no mortality occurred.

Any other information on results incl. tables

Table 1. Results of skin irritation study.

Observation time point	Animal number	Erythema score	Edema score	Remarks
1 h	1	1	0
	2	1	0
	3	1	0
24 h	1	1	0	+/- 50% of exposed area
	2	0	0
	3	1	0	+/- 50% of exposed area
48 h	1	1	0	+/- 50% of exposed area
	2	0	0
	3	0	0
72 h	1	1	0	+/- 5% of exposed area
	2	0	0
	3	0	0
7 d	1	0	0
	2	0	0
	3	0	0
mean over 24, 48 and 72 h	1	1.0	0.0
	2	0.0	0.0
	3	0.3	0.0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified