Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 434 (Acute Dermal Toxicity - Fixed Dose Procedure)
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Bis(2-ethylhexyl) 2,2'-thiobisacetate
EC Number:
246-131-9
EC Name:
Bis(2-ethylhexyl) 2,2'-thiobisacetate
Cas Number:
24293-43-4
Molecular formula:
C20H38O4S
IUPAC Name:
2-ethylhexyl 2-({2-[(2-ethylhexyl)oxy]-2-oxoethyl}sulfanyl)acetate
Details on test material:
- Name of test material (as cited in study report): Di(2-ethylhexyl) thiodiglycolate (Di-2-EHTDG)
- Physical state: slightly yellow to yellow, clear
- Analytical purity: 97.8%
- Main Impurities (identity and concentrations): Mono(2-ethylhexyl)thiodiglycolate; 2-ethylhexyl thioglycolate
- Lot/batch No.: 23015
- Storage condition of test material: at room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, D-33 178 Borchen.
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 140 - 163 g
- Housing: Macrolon cages on Altromin saw fiber bedding
- Diet (e.g. ad libitum): Altromin 1324 maintenance diet for rats and mice
- Water (e.g. ad libitum): tap water
- Acclimation period: at least 5 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-3
- Humidity (%): 45 - 65
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12


IN-LIFE DATES: From: 20 May 2008 To: 15 July 2008

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal trunk area
- % coverage: at least 10 % of the body surface
- Type of wrap if used: gauze-dressing and non-irritating tape, fixed with an additional dressing


REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test item was removed using tap water
- Time after start of exposure: 24 h


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.04 mL/kg bw.

Duration of exposure:
24 h
Doses:
single dose of 2000 mg/kg
No. of animals per sex per dose:
sighting study: 1
main study: 4
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing:
The animals were weighed prior to the application and once a week thereafter.
Detailed clinical examinations were performed immediately after the dosing, at least once during the first 30 minutes, periodically during the first 24 hours, with special attention given during the first 4 hours, and daily thereafter.

Primary skin irritation was assessed 1, 2 and 3 days after removal of the test substance using the scoring system laid down in OECD guideline 404.

- Necropsy of survivors performed: yes
- Other examinations performed:
Cageside observations included changes in the skin and fur, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern were examined. Particular attention was directed to observations of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma.

Results and discussion

Preliminary study:
No treatment related effects were observed
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: Wistar rat
Mortality:
No mortalities occured.
Clinical signs:
No clinical signs of toxicity were observed in all animals throughout the observation period.
Body weight:
All animals showed the expected gain in body weight.
Gross pathology:
No pathological abnormalities were noted.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the study results, no classification is required.
Executive summary:

In an acute dermal toxicity study five female Wistar rats were dermally exposed to a single dose of 2000 mg/kg bw of the undiluted test substance Di(2-ethylhexyl) thiodiglycolate (Di-2-EHTDG) for 24 h under semiocclusive conditions. The application area comprised at least 10 % of the body surface area. The animals were observed for 14 days after application. No mortalities occured and no clinical signs of systemic toxicity were noted. The acute dermal LD(50) was calculated to be > 2000 mg/kg bw.