2-ethylhexyl mercaptoacetate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 16 to 30 September 1993

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 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylhexyl mercaptoacetate

EC Number:

231-626-4

EC Name:

2-ethylhexyl mercaptoacetate

Cas Number:

7659-86-1

Molecular formula:

C10H20O2S

IUPAC Name:

2-ethylhexyl 2-sulfanylacetate

Details on test material:

- Name of test material (as cited in study report): 2-ethylhexylthioglycolate
- Physical state: colourles liquid
- Expiration date of the lot/batch: January 1994
- Storage condition of test material: at room temperature, away from light

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Iffa Credo (France)
- Age at the beginning of treatment: approximately 8 weeks old
- Weight at the beginning of treatment: mean: 265 +/- 10 g for males, 220 +/- 10 g for females
- Fasting period before study: not reported
- Housing: 4 to 7 animals per sex and per polycarbonate cage (48 x 27 x 20 cm)
- Diet (e.g. ad libitum): A04 C pelleted diet ad libitum
- Water (e.g. ad libitum): filtered by a Millipore membrane, ad libitum
- Acclimation period: at least 5 days before the beginning of the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-3
- Humidity (%): 50 +/- 20
- Air changes (per hr): 13
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: September 16, 1993 To: September 30, 1993

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 5 x 6 cm for females; 5 x 7 cm for males
- % coverage: 10%
- Type of wrap if used: restraining bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw (2.06 mL/kg)

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical signs at least once daily, mortality at least twice daily, weighing before application and on days 5, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: animals found dead and surviving animals sacrificed on day 15 were subject to macroscopic examination.

Statistics:

Not required (Limit test)

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

Two test animals were found dead. The first one (male) 4 hours after application and the second one (female) 24 hours after the application.

Clinical signs:

other: No cutaneous reactions were noted during the study. On day 2, sedation was observed in 4 animals. No other clinical signs were noted during the study.

Gross pathology:

No apparent abnormalities were observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The dermal LD50 of the substance was found to be greater than 2000 mg/kg bw in rats.

Executive summary:

Undiluted EHTG was applied to the skin of ten Sprague-Dawley male and female rats at a dose of 2000 mg/kg following OECD test guideline 402. The test site was then covered by a semi-occlusive dressing for 24 hours. Clinical signs, mortality and body weight gain were checked for a period of 14 days and all animals were subjected to necropsy. Death occurred in 20% of the animals. No skin reactions were observed. On day 2 following exposure a marked decrease in spontaneous activity was noted in 4 animals. On day 5, there was a decrease in the body weight in a few animals. Thereafter, clinical signs and body weight gain were not affected by treatment. A macroscopic examination revealed no abnormalities. The LD50 for EHTG was greater than 2000 mg/kg bw.