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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

Rat: OECD Guideline 401, oral LD50 (male/female) is > 2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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: Guideline study without detailed documentation
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Vehicle:
water
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: no mortalities
Mortality:
none
Clinical signs:
no effects
Gross pathology:
no effects on organs
Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
In an acute oral toxicity study according to OECD Guideline 401, groups of 5 Sprague-Dawley rats per sex were given a single oral dose of 2000 mg/kg bw of 1,3-Dioxan-2-one (TMC). No mortalities occurred. There were no treatment related clinical signs and necropsy findings. Thus, the oral LD50 (male/female) is > 2000 mg/kg bw.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In a acute oral toxicity study according to OECD Guideline 401, groups of 5 Sprague-Dawley rats per sex were given a single oral dose of 2000 mg/kg bw of 1,3-Dioxan-2-one (TMC). No mortalities occurred. There were no treatment related clinical signs and necropsy findings. Thus, the oral LD50 (male/female) is > 2000 mg/kg bw.


Justification for selection of acute toxicity – oral endpoint
Guideline study, GLP

Justification for classification or non-classification

Based on the available data 1,3 -Dioxan-2 -one (TMC) does not need to be classified for acute oral toxicity and requires no labelling according to Regulation (EC) 1272/2008.