reaction mass of dipentarythritol and 3-mercaptopropionic acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

30 July 2002 - 4 August 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

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:

Pentaerythritol tetrakis(3-mercaptopropionate)

EC Number:

231-472-8

EC Name:

Pentaerythritol tetrakis(3-mercaptopropionate)

Cas Number:

7575-23-7

Molecular formula:

C17H28O8S4

IUPAC Name:

3-[(3-sulfanylpropanoyl)oxy]-2,2-bis{[(3-sulfanylpropanoyl)oxy]methyl}propyl 3-sulfanylpropanoate

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CEGAV, Saint Mars d'Egrenne, France.
- Age at study initiation: 2 to 4 months
- Weight at study initiation: 2.4 ± 0.1 kg.
- Housing: individually in polystyrene cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3°C
- Humidity (%): 30 to 70%
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 2002-07-30 To: 2002-08-04

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 mL
- Concentration: undiluted

Duration of treatment / exposure:

3 min / 4 h (left / right flank)

Observation period:

5 days

Number of animals:

1+2

Details on study design:

TEST SITE
- Area of exposure: no data
- % coverage: no data
- Type of wrap if used: adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): test item was wiped off by means of a dry cotton pad
- Time after start of exposure: 3 min / 4 h (left/right flank)


SCORING SYSTEM:
0-4, as laid down in OECD 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 5 days

Remarks on result:

other: 3 min exposure

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: 3-min exposure

Results 3

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

other: 4-h exposure

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: 4-h exposure

Results 5

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

other: 4-h exposure

Results 6

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: 4-h exposure

Results 7

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

other: 4-h exposure

Results 8

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: 4-h exposure

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

PETMP is not irritating to skin.

Executive summary:

The potential of the test item PETMP to induce skin irritation was evaluated in rabbits according to OECD (No. 404, 17th July 1992) and EC (92/69/EEC, B.4, 31st July 1992) guidelines. The study was conducted in compliance with the principles of Good Laboratory Practice Regulations.

In the first instance, the test item was applied for periods of 3 minutes and 4 hours to a single male New Zealand White rabbit. Since the test item was not severely irritant on this first animal, it was then applied for 4 hours to two other animals. A single dose of 0.5 mL of the undiluted test item was applied to the closely-clipped skin of one flank. The test item was held in contact with the skin by means of a semi-occlusive dressing. Cutaneous reactions were observed approximately 1 hour, 24, 48 and 72 hours after removal of the dressing and then daily until reversibility of cutaneous reactions.The mean values of the scores for erythema and oedema were calculated for each animal.

After a 3-minute exposure (one animal): A very slight erythema was noted, on day 4 only. No other cutaneous reactions were observed.

After a 4-hour exposure (three animals): No cutaneous reactions were noted.

Mean scores over 24, 48 and 72 hours for each animal were 0.0, 0.0 and 0.0 for erythema and oedema.

Under our experimental conditions, the test item PETMP is non-irritant when appliedtopically to rabbits.