Isooctyl mercaptoacetate

Endpoint summary

Description of key information

The substance iOTG is slightly irritating to the skin (Clouzeau, 1993) and eyes (Clouzeau, 1994). No sign of respiratory irritation has been observed in an acute inhalation toxicity study (Rampy, 1973).

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute 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: 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

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.

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

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

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

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.

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (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:

29-Sep-1993 to 07-Jan-1994

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

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues 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 +/- 0.3 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

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

Amount applied: 0.1 ml

Duration of treatment / exposure:

24 hour(s)

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

3

Details on study design:

A single dose of 0.1 mL of the undiluted test item was instilled into the conjunctival sac of the left eye of 3 male New Zealand 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.

Irritation parameter:

chemosis score

Remarks:

Chemosis and Redness

Basis:

mean

Time point:

24 h

Score:

ca. 0

Max. score:

0.3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Interpretation of results:

GHS criteria not met

Conclusions:

Under our experimental conditions, the test substance iOTG was considered as non-irritant when administered by ocular route in rabbits.

Executive summary:

0.1 mL undiluted IOTG was instilled into the conjunctival sac of the left eye of 3 male rabbits following OECD test guideline 405. 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. Slight chemosis and/or redness of the conjunctiva were noted within 24 hours post-treatment. No ocular reactions were observed on days 3 and 4. No iris lesions and no corneal opacity were noted during the study. The mean scores over 24, 48 and 72 hours for individual animals were 0.0, 0.0 and 0.0 for chemosis; 0.3, 0.0 and 0.0 for redness; 0.0, 0.0 and 0.0 for iris lesions and 0.0, 0.0 and 0.0 for corneal opacity.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Justification for classification or non-classification

According to REGULATION (EC) No 1272/2008 of 16 December 2008 and the available skin and eye irritation data, iOTG should not be classified as irritating to skin or eyes.