Butanedioic acid, 2,3-dihydroxy- [R-(R*,R*)]-,C12-13-branched alkyl esters

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Butanedioic acid, 2,3-dihydroxy- [R-(R*,R*)]-,C12-13-branched alkyl esters

EC Number:

947-004-7

Molecular formula:

C28H56O6 - C29H58O6 - C30H60O6

IUPAC Name:

Butanedioic acid, 2,3-dihydroxy- [R-(R*,R*)]-,C12-13-branched alkyl esters

Test material form:

liquid

Details on test material:

product

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Padre Antonio - Mariano Comense (CO)
- Age at study initiation: no data
- Weight at study initiation: 2.5 - 3.5 kg
- Housing: singly in stainless steel cages (dimensions: 450x500x380 mm) equipped with automatic washing cycle
- Diet (e.g. ad libitum): standard pellet complete diet ad libitum by the authorized breeder RIEPER
- Water (e.g. ad libitum): filtered tap water from local network ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
Temperature and humidity were regulated by a conditioning plant and were continuously recorded, no further details mentioned
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 10-March-1992 To: 17-March-1992

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: non-treated area of the skin; each animal served as its own control, the non-treated area is on the left side of the back

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg

EXPERIMENTAL DESIGN
Each animal served as its own control, having a treated and a non-treated area, the first on the right side and the latter on the left side of its back.

Duration of treatment / exposure:

4 h

Observation period:

after 60 min, 24, 48 and 72 hours

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: approx. 20 cm² on the right flank
- % coverage: no data
- Type of wrap if used: the sample was placed under a pad, which was kept in place by means of thin bands of adhesive hypoallergenic tape (Blenderm 3M), wrapped with rubberized cloth (Acrylastic Beyersdorf AG Hamburg)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with a pad soaked in distlilled water
- Time after start of exposure: 4 h

SCORING SYSTEM: according to guideline

Skin preparation:
Approximately 24 hours before the test fur was removed from an area approximateky 240 cm2 wide by clipping and shaving the dorsal and flank zones of the animals. An area of about 20 cm2 on the right flank was used for the application of the assay sample. Care was taken to avoid abrading the skin. Only animals with healthy intact skin were used.

Administration:
Square gauze pads 2.5 cm x 2.5 cm fixed to adhesive tape (Hansamed strips) were used. 0.5 g of the assay sample were placed under the pad, which was kept in place by means of thin bands of adhesive hypoallergenic tape (Blenderm 3M). The entire trunk of the animal was then wrapped with rubberized cloth (Acrylastic Beyersdorf AG Hamburg).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 60 minutes

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 60 minutes

Score:

1

Max. score:

4

Results 4

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Score:

0.67

Max. score:

4

Results 5

Irritation parameter:

erythema score

Basis:

mean

Time point:

48 h

Score:

0.57

Max. score:

4

Results 6

Irritation parameter:

erythema score

Basis:

mean

Time point:

72 h

Score:

0.33

Max. score:

4

Irritant / corrosive response data:

see table below

Other effects:

none

Any other information on results incl. tables

Table: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Erythema	Edema
	Max. score: 4	Max. score: 4
60 min	1/1/1/1/1/1	0/0/0/0/0/0
24 h	0/1/1/0/1/1	0/0/0/0/0/0
48 h	0/1/1/0/0/1	0/0/0/0/0/0
72 h	0/1/1/0/0/0	0/0/0/0/0/0
5 d	0/0/0/0/0/0	0/0/0/0/0/0
Reversibility*)	yes	-

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions the test material Butanedioic acid, 2,3-dihydroxy-[R-(R*, R*)], C12-13-branched alkyl esters can be considered as non-irritant.

Executive summary:

The test was performed by means of a single dose application of the test material Butanedioic acid, 2,3-dihydroxy-[R-(R*, R*)], C12-13-branched alkyl esters on the skin of 6 albino male rabbits according to OECD Guideline 404.

The test material was applied to the skin of 6 rabbits at a dose of 500 mg for 4 hours. The animals were observed after the removal of the bandages and after 24, 48 and 72 hours for signs of erythema or oedema. During the study a slight erythema was observed, this erythema disappeared after 72 hours.

Under the test conditions the test material Butanedioic acid, 2,3-dihydroxy-[R-(R*, R*)], C12-13-branched alkyl esters can be considered non-irritant for the skin accoriding to GHS criteria.