2,2-bis(bromomethyl)propane-1,3-diol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and appropriate guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

other: OECD single dose oral toxicity (limit) test

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,2-bis(bromomethyl)propane-1,3-diol

EC Number:

221-967-7

EC Name:

2,2-bis(bromomethyl)propane-1,3-diol

Cas Number:

3296-90-0

Molecular formula:

C5H10Br2O2

IUPAC Name:

2,2-bis(bromomethyl)propane-1,3-diol

Details on test material:

2,2-bis(bromomethyl)-1,3-propanediol (CAS No. 3296-90-0)
Purity: 98.96%

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Age: 5-8 weeks old (bodyweight 136-153g males, 136-146g females)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

Volume administrated: 10 ml/kg
Post dose observation period: range finding study: 5 days Main study: 14 days

Doses:

2000 mg/kg

No. of animals per sex per dose:

Range finding study: 1 male, 1 female Main study: 5 males, 5 females

Control animals:

no

Details on study design:

The method used followed that described in the OECD guidelines for testing chemicals (1987) No. 401 "Acute oral Toxicity" referenced as Method B1 in the Comission Directive 84/449/EEC. Following a range finding study, a group of ten fasted rats (5 males and 5 females) was given a single oral dose of test material, as a suspension in archis oil B.P. at a dose level of 2000mg/kg bw. The animals were observed for 14 days after the day of dosingand were killed for gross pathological examination.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

Range finding study: There were no deaths.
Main study: Three animals (one male and two females) were found dead thirty minutes or one hr after dosing

Clinical signs:

other: Range finding study: Common signs of systemic toxicity noted were hunched posture, lethargy, ataxia, laboured respiration,decreased respiratory rate and ptosis with additional signs of pilo-erection, loss righting reflex, red/brown staining around the eye

Gross pathology:

Main study: abnormalities noted at necropsy of animals that died during the study were dark liver, dark kidneys and slight haemorrhage of the gastric mucosa. No abnormalities were noted at necropsy of animals that were killed at the end of the study.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute median lethal dose (LD50) was found to be greater than 2000 mg/kg bodyweight.