Pentaerythritol tetrakis(3-mercaptopropionate)

Endpoint summary

Description of key information

PETMP is not irritating to skin or eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

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

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

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

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

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

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

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

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

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

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2-5 August 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: CEGAV, Saint Mars d'Egrenne, France.
- Age at study initiation: 2 to 4 months
- Weight at study initiation: 2.5 ± 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: 2002-08-02 To: 2002-08-05

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 100 µL

Duration of treatment / exposure:

Eyes were not rinsed

Observation period (in vivo):

3 days

Number of animals or in vitro replicates:

1+2

Details on study design:

REMOVAL OF TEST SUBSTANCE: no

SCORING SYSTEM: as laid down in OECD 405

TOOL USED TO ASSESS SCORE: UV lamp / fluorescein

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Only very slight conjunctival reactions, including very slight chemosis (grade 1), very slight redness of the conjunctiva (grade 1) and clear discharge, were observed in all animals on day 1.
No other ocular reactions were observed during the study. Mean scores calculated for each animal over 24, 48 and 72 hours were 0.0, 0.0 and 0.0 for chemosis, redness of the conjunctiva, iris lesions and corneal opacity.

Interpretation of results:

GHS criteria not met

Conclusions:

PETMP is not irritating to eyes

Executive summary:

The potential of the test item PETMP to induce ocular irritation was evaluated in rabbits according to OECD (No. 405, 24th February 1987) and EC (92/69/EEC, B.5,31st July 1992) guidelines. The study was conducted in compliance with the principles of Good Laboratory Practice Regulations.

A single dose of 0.1 mL of the undiluted test item was instilled into the left conjunctival sac of three male New Zealand White rabbits. The right eye was not treated and served as control. The eyes were not rinsed after administration of the test item. Ocular reactions were observed approximately 1 hour, 24, 48 and 72 hours after the administration. The mean values of the scores for chemosis, redness of the conjunctiva, iris lesions and corneal opacity were calculated for each animal.

Only very slight conjunctival reactions (very slight chemosis, very slight redness of the conjunctiva and clear discharge) were observed in all animals on day 1. No other ocular reactions were observed during the study. Mean scores calculated for each animal over 24, 48 and 72 hours were 0.0, 0.0 and 0.0 for chemosis, redness of the conjunctiva, iris lesions and corneal opacity.

Under our experimental conditions, the test item PETMP is non-irritant when administered by ocular route to rabbits.

 

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

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 singlemale 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 andoedema.

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

 

Eye irritation

The potential of the test item PETMP to induce ocular irritation was evaluated in rabbits according to OECD (No. 405, 24th February 1987) and EC (92/69/EEC, B.5,31st July 1992) guidelines. The study was conducted in compliance with the principles of Good Laboratory Practice Regulations.

A single dose of 0.1 mL of the undiluted test item was instilled into the left conjunctival sac of three male New Zealand White rabbits. The right eye was not treated and served as control. The eyes were not rinsed after administration of the test item. Ocular reactions were observed approximately 1 hour, 24, 48 and 72 hours after the administration. The mean values of the scores for chemosis, redness of the conjunctiva, iris lesions and corneal opacity were calculated for each animal.

Only very slight conjunctival reactions (very slight chemosis, very slight redness of the conjunctiva and clear discharge) were observed in all animals on day 1. No other ocular reactions were observed during the study. Mean scores calculated for each animal over 24, 48 and 72 hours were 0.0, 0.0 and 0.0 for chemosis, redness of the conjunctiva, iris lesions and corneal opacity.

Under our experimental conditions, the test item PETMP is non-irritant when administered by ocular route to rabbits.

 

 

Justification for classification or non-classification

The criteria for classification as corrosive or irritating are not fulfilled. No or only very slight irritation was observed in vivo.