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Toxicological information

Acute Toxicity: dermal

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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:
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:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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
Key result
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:
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.
Body weight:
Between days 1 to 5, a decrease in body weight was noted in 3 test animals and a decrease of the bodyweight gain was observed in the remaining test animals. The body weight of these animals showed an increase during the remainder of the study period.
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.