Bis(C12-C13)alkyl-2-hydroxybutandioate

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:

other: GLP 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

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Name of test material (as cited in study report): COSMACOL EMI
- Substance type: pure active substance
- Physical state: liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: conelli Arona (NO), Italy
- 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
- Water (e.g. ad libitum): filtered tap water 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: 01-JUN-1992 To: 08-JUN-1992

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: sesame seed oil

Controls:

other: non-treated area of the skin

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg
- Concentration (if solution): 500 mg was turned to a paste with 0.5 mL of sesame oil

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Lot/batch no. (if required): no data
- Purity: no data

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, wrapped with rubberized cloth

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

SCORING SYSTEM: according to guideline

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0

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	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	-	-

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions the test material Bis(C12-C13)alkyl-2-hydroxybutandioate can be considered as non-irritant.

Executive summary:

The test was performed by means of a single dose application of the test material Bis(C12-C13)alkyl-2-hydroxybutandioate 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 in 0.5 mL sesame seed oil/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 no erythema nor oedema were detected.

Under the test conditions the test material Bis(C12-C13)alkyl-2-hydroxybutandioate can be considered non-irritant for the skin.