Isooctyl mercaptoacetate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Isooctyl mercaptoacetate

EC Number:

246-613-9

EC Name:

Isooctyl mercaptoacetate

Cas Number:

25103-09-7

Molecular formula:

C10H20O2S

IUPAC Name:

2-methylheptyl 2-sulfanylacetate

Details on test material:

Identification: Isooctyl thioglycolate (IOTG)
CAS no. 25103-09-7
Source: Elf Aquitaine production
Batch: TA 2511
Purity: 99.05 % (w/w)

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, 80160 Prouzel, France
- Age at study initiation: no data
- Weight at study initiation: 3.0 +/- 0.2 kg
- Housing: individually in polystyrene cage
- Diet (ad libitum): 112 C pelleted diet (UAR)
- Water (ad libitum): filtered tap water
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3°C
- Humidity (%): 50 +/- 20°C
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 ml

Duration of treatment / exposure:

4 hour(s)

Observation period:

up to 8 days

Number of animals:

3

Details on study design:

A single dose of 0.5 mL of the undiluted test item was applied to the closely-clipped skin of one flank of 3 male New Zealand White rabbits.  The test item was held in contact with the skin for 4 hours 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 8 days  in order to observed their reversibility. The mean values of the scores for erythema and oedema were calculated for each animal.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24 + 48 + 72 h

Score:

1.7

Max. score:

4

Reversibility:

fully reversible within: 6 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24 + 48 + 72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24 + 48 + 72 h

Score:

1.7

Max. score:

4

Reversibility:

fully reversible within: 5 days

Results 4

Irritation parameter:

edema score

Basis:

other: animal #1, 2 & 3

Time point:

other: 24 + 48 + 72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Moderate cutaneous reactions were observed for up to 48 hours after removal of the dressing. They consisted of erythema in 3 animals (scores of 1 and 2). The mean scores over 24, 48 and 72 hours for individual animals were 1.0, 1.7 and 1.7 for erythema and 0.0 for edema. Between days 3 and 7, a dryness of the skin was observed at the treatment site in 1 animal. No ulceration or necrosis was noted.

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information Not classified Criteria used for interpretation of results: other: REGULATION (EC) No 1272/2008 of 16 December 2008

Conclusions:

The substance iOTG was slightly irritating under the conditions of the test.

Executive summary:

A single dose of 0.5 mL undiluted IOTG was applied to the skin of 3 male New Zealand White rabbits under a semi-occlusive dressing for four hours following OECD test guideline 404. Skin reactions were observed approximately 1 hour, 24, 48 and 72 hours after removal of the dressing and then daily until 8 days in order to observed their reversibility. The mean values of the scores for erythema and edema were calculated for each animal. Moderate cutaneous reactions were observed for up to 48 hours after removal of the dressing. They consisted of erythema in 3 animals. Between days 3 and 7, a dryness of the skin was observed at the treatment site in 1 animal. No ulceration or necrosis was noted. The mean scores over 24, 48 and 72 hours for individual animals were 1.0, 1.7 and 1.7 for erythema and 0.0 for edema. IOTG was slightly irritating under the conditions of this test.