4,4,5,5-Tetramethyl-1,3,2-dioxaborolane

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:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Raw data of acute toxicity study containing limited information but adequate for the purposes of hazard identification and classification.

Justification for type of information:

In contact with water 4,4,5,5-Tetramethyl-1,3,2-dioxaborolane undergoes a rapid hydrolysis to form boric acid (CAS 10043-35-3) and pinacol (CAS 76-09-5). Since boric acid seems to be the more toxic degradation product, the read across to this compound is scientifically justified.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

acute toxic class method

Species:

rat

Strain:

Sprague-Dawley

Sex:

male

Route of administration:

oral: gavage

Doses:

1000, 1990, 2510, 3160, 3980, 5010, and 10000 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Sex:

male

Dose descriptor:

LD50

Effect level:

3 350 mg/kg bw

1000 mg/kg bw: 0% mortality

1990 mg/kg bw: 0% mortality

2510 mg/kg bw: 10% mortality

3160 mg/kg bw: 20% mortality

3980 mg/kg bw: 90% mortality

5010 mg/kg bw: 100% mortality

10000 mg/kg bw: 100% mortality

Conclusions:

The LD50 of the test material was determined to be 3350 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

3 350 mg/kg bw

Quality of whole database:

Raw data of acute toxicity study with the read across substance boric acid (CAS 10043-35-3) containing limited information but adequate for the purposes of hazard identification and classification.

Additional information

oral

In an acute oral toxicity study (Cognis, 1966), a group of 10 male Sprague Dawley rats were given a single oral dose of boric acid (read across, CAS 10043-35-3) as an emulsion in a dose range of 1000 -10000 mg/kg bw and observed for 14 days. Mortality was reported from the dosage of 2510 mg/kg bw onward.

Justification for selection of acute toxicity – oral endpoint
only study available

Justification for classification or non-classification

Classification for acute toxicity is not warranted according to the criteria of EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No 1272/2008.