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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1998
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
SOLE 2
IUPAC Name:
SOLE 2

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Vehicle:
other: Deionized water added with 2N NaOH (retaining the molar ratio of Sole 2:NaOH = 1:0.729)

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 200 - < 2 000 mg/kg bw
Mortality:
Male: 200 mg/kg bw; Number of animals: 3; Number of deaths: 0
Male: 500 mg/kg bw; Number of animals: 3; Number of deaths: 0
Male: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 2
Female: 200 mg/kg bw; Number of animals: 3; Number of deaths: 0
Female: 500 mg/kg bw; Number of animals: 3; Number of deaths: 0
Clinical signs:
other: Signs of toxicity related to dose levels: Sedation or hypoactivity, piloerection and increased salivation were observed in the animals treated at 2000 mg /kg, starting in general 30 minutes after treatment. Recovery was achieved on day 6 in surviving anim
Gross pathology:
Effects on organs:
At the macroscopic examination, one male died on the first day of dosing showed dark liver.
At the final killing no appreciable post-mortem changes were noted.

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
On the basis of the results obtained it can be stated that the LD50 fall between 200 and 2000 mg/kg of SOLE 2 (220.4 and 2004 mg/kg of SOLE 3), then the substance is to be classified as HARMFUL and labelled Xn.