1,2,3-Propanetricarboxylic acid, 2-hydroxy-, tri-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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study with acceptable restrictions

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:

1,2,3-Propanetricarboxylic acid, 2-Hydroxy-, tris(C12-13-branched-alkyl)ester

EC Number:

944-989-5

Cas Number:

2156592-46-8

Molecular formula:

C42H80O7 - C45H86O7

IUPAC Name:

1,2,3-Propanetricarboxylic acid, 2-Hydroxy-, tris(C12-13-branched-alkyl)ester

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report): 1,2,3-Propanetricarboxylic acid, 2-Hydroxy-, tris(C12-C13-branched-alkyl)ester
- Physical state: liquid
- Storage condition of test material: Room temperature, protected from light in the tightly closed original container

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, Italy
- Age at study initiation: no data
- Weight at study initiation: 2,5 - 3,5 kg
- Housing: stainless steel cages (4S0x500x380 mm) equipped with automatic washing cycle
- Diet: standard pellet complete diet supplied by the authorized breeder
- Water: filtered tap water from local network ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1992-06-01 To: 1992-06-04

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: yes, a non-treated area of skin on the left site of the back

Amount / concentration applied:

500 mg

Duration of treatment / exposure:

4 h

Observation period:

24, 48 and 72 h after treatment

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: 20 cm² of the right flank
- % coverage: no data
- Type of wrap if used: square gauze pad (2.5 x 2.5 cm) fixed to adhesive tape (Hansamed strips) , kept in plase by thin bands of adhesive hypoallergenic tape (Blenderm 3M), the entire trunk of the animal then wrapped with rubberized cloth (Acrylastic Beyersdorf AG , Hamburg)

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

SCORING SYSTEM:
see Table #1 below

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Any other information on results incl. tables

Table #2: 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	0/0/0/0/0/0	0/0/0/0/0/0
24 h	0/0/0/0/0/0	0/0/0/0/0/0
48 h	0/0/0/0/0/0	0/0/0/0/0/0
72 h	0/0/0/0/0/0	0/0/0/0/0/0
Average 24h, 48h, 72h	0	0
Reversibility*)	-	-
Average time (unit) for reversion	-	-

 

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under test conditions the target substance 1,2,3 -Propanetricarboxylic acid, 2 -hydroxy-, tris(C12 -13 -branched-alkyl) ester can be considered non irritant.

Executive summary:

The test was performed by means of a single dose application of the target substance 1,2,3 -Propanetricarboxylic acid, 2 -hydroxy-, tris(C12 -13 -branched-alkyl) ester on the skin of 6 albino male rabbits. The test material was applied to the shaved skin of 6 rabbits at a dose of 500 mg/rabbit 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 in all treated animals no erythema and edema was observed. Under test conditions the test material can be considered non irritant.