Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report Date:
2019

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Crl:WI(Han)
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
methylcellulose
Doses:
1x 300 mg/kg bw, 5*2000 mg/kg bw
No. of animals per sex per dose:
1x 300 mg/kg bw, 5*2000 mg/kg bw
Control animals:
no

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
There were no deaths
Clinical signs:
The only clinical sign seen was piloerection which was noted in the animal treated at
300 mg/kg and in one animal treated at 2000 mg/kg, at 2 to 3 hours after dosing.
Body weight:
All rats achieved body weight gains during the first and second weeks of the study
Gross pathology:
No abnormalities were noted at necropsy
Other findings:
Norelevant chanfesin Haematology and chlinical chemistry

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test article, 2,2'-ethylenedithiodiethanol, was considered to have no significant
acute toxic risk in respect of its acute oral toxicity and did not meet the criteria for
classification according to the Globally Harmonized System of Classification and
Labelling of Chemicals (GHS).