Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Principles of method if other than guideline:
Non-GLP, non-guideline study in male Wistar rats administered with 5 mL/kg bw of the test substance to investigate the acute oral toxicity.
GLP compliance:
no
Test type:
standard acute method
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): Weichmacher VP KA 9073
- Analytical purity: not reported

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Germany
- Age at study initiation: not reported
- Weight at study initiation: 180 - 200 g
- Housing: 5 animals per cage

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
single dose
Doses:
5 mL/kg
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: not reported
- Necropsy of survivors performed: not reported

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Remarks on result:
other: Wistar rat
Mortality:
No mortalities occured.
Clinical signs:
No clinical signs of toxicity were observed.
Body weight:
not reported
Gross pathology:
not reported

Any other information on results incl. tables

LD50 estimate is so high (>5 g/kg bw) that potential sex differences or possible effects by non-fasting will be irrelevant.

The study is reliable for classification and labelling purposes.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No classification required.
Executive summary:

In an acute oral toxicity study 10 male Wistar rats were administered one oral dose of 5000 mg/kg of the undiluted test substance. The animals were observed for 14 days. No mortalities occured on no clinical signs of toxicity were observed. The LD(50) after oral administration to male Wistar rats was > 5000 mg/kg bw.