Registration Dossier

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:
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.