1-(2,6-bis(4-tolyl)-1,3-dioxano(5,4-d)-1,3-dioxan-4-yl)ethane-1,2-diol

Endpoint summary

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:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The information of this endpoint has been provided by ECHA as a result of an inquiry, thus the full access to data in the report is not accessible to the registrant

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

not specified

Sex:

male/female

Route of administration:

oral: unspecified

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

suspension of the substance in 0.5% aqueous sodiumcarboxymethyl cellulose

Doses:

2100 mg/kg bw

No. of animals per sex per dose:

Male: 2100 mg/kg bw; Number of animals: 5
Female: 2100 mg/kg bw; Number of animals: 5

Control animals:

not specified

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 100 mg/kg bw

Based on:

not specified

Mortality:

Male: 2100 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2100 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: Signs of toxicity related to dose levels: There were no deaths and no signs of toxicity

Gross pathology:

Effects on organs: No effects were observed at necropsy.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 100 mg/kg bw

Quality of whole database:

Three studies available, GLP compliant, done according to EU-methods annex V, B1

Additional information

Acute oral toxicity: three studies are available, all of them following the EU Method B1. The results are respectively >2100 mg/kg bw, >2000 mg/kg bw and >5000 mg/kg bw showing a profile non toxic for this substance.

Justification for selection of acute toxicity – oral endpoint
see discussion

Justification for classification or non-classification

LD50 (oral)=2100 mg/kg bw. The value is above the limit 2000 mg/kg bw for classification. Therefore the substance is not classified for acute oral toxicity hazard.