Registration Dossier

Administrative data

Description of key information

An assessment was performed based on the outcome of a short-term repeated-dose toxicity study performed on the substance via the oral route to determine the acute oral toxicity of the registered substance. As a conclusion 1-[(2-hydroxyethyl)thio]propan-2-ol is expected to have a low acute oral toxicity with an LD50 > 2000 mg/kg.

In accordance with Annex VIII of REACH, Column 2, testing by the inhalation and dermal routes is only appropriate if exposure of humans via these routes is likely. 1-[(2-hydroxyethyl)thio]propan-2-ol is not made available on the EU market as a monomer and is imported already polymerised. Therefore no exposure of humans via the dermal and inhalation routes is expected.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
other: Expert assessment
Adequacy of study:
key study
Study period:
August 11, 2017
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Assessment based on the outcome of a short-term repeated-dose toxicity study performed on the substance via the oral route.
Qualifier:
no guideline followed
Principles of method if other than guideline:
Assessment based on the outcome of a short-term repeated-dose toxicity study performed on the substance via the oral route.
GLP compliance:
no
Test type:
other: Assessment based on the outcome of a short-term repeated-dose toxicity study performed on the substance via the oral route.
Limit test:
no
Sex:
male/female
Key result
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
other: weight of evidence

see attached report.

Interpretation of results:
GHS criteria not met
Conclusions:
1-[(2-hydroxyethyl)thio]propan-2-ol is expected to have a low acute oral toxicity with an LD50 > 2000 mg/kg.
Executive summary:

An assessment was performed based on the outcome of a short-term repeated-dose toxicity study performed on the substance via the oral route to determine the acute oral toxicity of the registered substance. As a conclusion 1-[(2-hydroxyethyl)thio]propan-2-ol is expected to have a low acute oral toxicity with an LD50 > 2000 mg/kg. The substance did not meet the criteria for classification according to Regulation (EC) No.1272/2008.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw
Quality of whole database:
Assessment based on the outcome of a short-term repeated-dose toxicity study performed on the substance via the oral route.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
In accordance with Annex VIII of REACH, Column 2, testing via inhalation is appropriate if exposure of humans is likely. 1-[(2-hydroxyethyl)thio]propan-2-ol is not made available on the EU market as a monomer and is imported already polymerised. Therefore no exposure of humans via inhalation is expected.
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because skin contact in production and/or use is not likely
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
In accordance with Annex VIII of REACH, Column 2, testing by the dermal route is appropriate if exposure of humans is likely via this route. 1-[(2-hydroxyethyl)thio]propan-2-ol is not made available on the EU market as a monomer and is imported already polymerised. Therefore no exposure of humans by the dermal route is expected in production and/or use.
Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

An assessment was performed based on the outcome of a short-term repeated-dose toxicity study performed on the substance via the oral route to determine the acute oral toxicity of the registered substance. As a conclusion 1-[(2-hydroxyethyl)thio]propan-2-ol is expected to have a low acute oral toxicity with an LD50 > 2000 mg/kg. The substance did not meet the criteria for classification according to Regulation (EC) No.1272/2008.

In accordance with Annex VIII of REACH, Column 2, no acute testing of 1-[(2-hydroxyethyl)thio]propan-2-ol via the inhalation and dermal routes was performed as exposure to humans by these routes is unlikely.