2-ethylhexyl mercaptoacetate

Endpoint summary

Description of key information

EHTG was found to be slightly irritating to skin and no ocular reactions were observed in rabbits.

 

Skin Irritation

A single dose of 0.5 mL undiluted EHTG was applied to the skin of 3 male New Zealand White rabbits under a semi-occlusive dressing for four hours (Clouzeau, 1993) 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 oedema were calculated for each animal. The mean scores over 24, 48 and 72 hours for individual animals were 1.3, 1.7, and 1.3 for erythema and 0.0, 0.0, and 0.3 for edema. No ulceration of necrosis was noted. Erythema and edema had reversed by day 6 and by day 3, respectively. EHTG was slightly irritating under the conditions of this test.

 

Eye irritation

0.1 mL undiluted EHTG was instilled into the conjunctival sac of the left eye of 3 male rabbits (Clouzeau, 1993) 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. No ocular reactions were observed during the study; EHTG was not irritating to the rabbit eye under the conditions of this study.

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:

From 7 to 21 September 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

Study conducted prior to the adoption of the most recent version of this Guideline

Deviations:

yes

Remarks:

The results of clinical examination were not reported; the age of animals was not indicated; the temperature limits were below the recomended ones.

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, France
- Age at study initiation: not reported
- Weight on the day of treatment: mean: 2.9 +/- 0.3 kg
- Housing: individually in polystyrene cages (35 x 55 x 32 cm or 48.2 x 55 x 36.5 cm)
- Diet (e.g. ad libitum): 112 C pelleted diet
- Water (e.g. ad libitum): filtered by a Millipore membrane
- Acclimation period: at least 5 days before the beginning of the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3
- Humidity (%): 50 +/- 20
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 7 september 1993 To: 21 September 1993

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped using electric clippers

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

4 hour(s)

Observation period:

8 days following exposure

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6 cm2 gauze patch
- Type of wrap if used: restraining bandage


REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 hours


SCORING SYSTEM: Erythema and oedema were noted from 0 (no observation) to 4 (severe observation)

Irritation parameter:

erythema score

Basis:

other: animals #1 and 3

Time point:

other: 24 + 78 + 72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 6 days

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24 + 48 + 72 h

Score:

1.66

Max. score:

4

Reversibility:

fully reversible within: 6 days

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24 + 48 + 72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 2 days

Irritation parameter:

edema score

Basis:

other: animals #2 and 3

Time point:

other: 24 + 48 + 72 h

Score:

0

Max. score:

4

Other effects:

Results for mortality and behaviour were not reported.

Moderate cutaneous reactions were observed for up to 48 hours after removal of the dressing. They consisted of erythema (scores of 1 and 2) and oedema (score of 1) in 3 animals. Erythema and oedema had reversed by day 6 and 3, respectively.

By day 4, a dryness of the skin was observed at the treatment site. No ulceration or necrosis was observed.

Table 1 Individual skin irritation scores according to the Draize scheme

	Erythema			Oedema
Animal No	1	2	3	1	2	3
After 0.5 - 1 h	1	2	1	0	0	0
After 24 h	2	2	2	1	0	0
After 48 h	1	2	1	0	0	0
After 72 h	1	1	1	0	0	0
Mean score 24-72 h	1.44			0.11
Day 5	1	1	1	0	0	0
Day 6	0	0	0	0	0	0
Day 7	0	0	0	0	0	0
Day 8	-	0	0	-	0	0

- cutaneous examination not performed

Interpretation of results:

GHS criteria not met

Conclusions:

The substance was found to be slightly irritating to rabbits skin with some erythema observed and scored 2. No more erythema were observed at day 6 post-treatment. Only slight oedema (score 1) was observed in one animal at 24 h following application.

Executive summary:

A single dose of 0.5 mL undiluted EHTG 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 oedema were calculated for each animal. The mean scores over 24, 48 and 72 hours for individual animals were 1.3, 1.7, and 1.3 for erythema and 0.0, 0.0, and 0.3 for edema. No ulceration of necrosis was noted. Erythema and edema had reversed by day 6 and by day 3, respectively. EHTG was slightly irritating under the conditions of this test. 

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:

From 21 to 24 September 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

Study conducted prior to the adoption of the most recent version of this Guideline

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, France
- Sex: male
- Age at study initiation: not reported
- Weight on the day of treatment: 3.1 +/- 0.5 kg
- Housing: individually in polystyrene cages (35 x 55 x 32 or 48.2 x 58 x 36.5 cm)
- Diet: 112 C pelleted diet ad libitum
- Water: filtered by Millipore membrane ad libitum
- Acclimation period: at least 5 days before the beginning of the study


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3
- Humidity (%): 50 +/- 20
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 21 September 1993 To: 24 September 1993

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL was instilled into the conjunctival sac of the left eye of rabbits

Duration of treatment / exposure:

The eyes were not rinsed after administration of the test substance

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: no


SCORING SYSTEM: treated eyes were scored for conjunctival lesions and discharge, iris lesions and corneal lesions.

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24 +48 + 72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24 +48 + 72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24 +48 + 72 h

Score:

0

Max. score:

3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24 +48 + 72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

No ocular reactions were observed during the study.

Interpretation of results:

GHS criteria not met

Conclusions:

2-ethylhexyl mercaptoacetate is not irritating to eyes.

Executive summary:

0.1 mL undiluted EHTG 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. No ocular reactions were observed during the study; EHTG was not irritating to the rabbit eye under the conditions of this study.

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, 2 -ethylhexyl mercaptoacetate should not be classified as irritating to skin or eyes.