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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

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2-Bis(bromomethyl)propane-1,3-diol, oligomeric reaction products with 1-chloro-2,3-epoxypropane
EC Number:
500-073-3
EC Name:
2,2-Bis(bromomethyl)propane-1,3-diol, oligomeric reaction products with 1-chloro-2,3-epoxypropane
Cas Number:
31452-80-9
Molecular formula:
(C5H10Br2O2.C3H5ClO)x
IUPAC Name:
2-{[2,2-bis(bromomethyl)-3-[(oxiran-2-yl)methoxy]propoxy]methyl}oxirane; 2-{[2,2-bis(bromomethyl)-3-{3-chloro-2-[(oxiran-2-yl)methoxy]propoxy}propoxy]methyl}oxirane
Test material form:
liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
DMSO
Details on oral exposure:
A total of five animals were therefore treated at a dose level of 2000 mg/kg in the study. All animals were dosed once only by gavage, using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to the fasted body weight at the time of dosing. Treatment of animals was sequential. Sufficient time was allowed between each dose group to confirm the survival of the previously dosed animals. Clinical observations were made 30 minutes, 1, 2, and 4 hours after dosing and then daily for up to 14 days. Morbidity and mortality checks were made twice daily, early and late during normal working days, and once daily at weekends and public holidays. Individual body weights were recorded on Day 0 (the day of dosing) and on Days 7 and 14. At the end of the observation period the animals were killed by cervical dislocation. All
animals were subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.
Doses:
2000 mg/kg bw
300 mg/kg bw
No. of animals per sex per dose:
2000 mg/kg bw: 5 female
300 mg/kg bwL 1 females
Control animals:
no
Details on study design:
Clinical observations were made 30 minutes, 1, 2, and 4 hours after dosing and then daily for up to 14 days. Morbidity and mortality checks were made twice daily. Individual body weights were recorded on Day 0 (the day of dosing) and on Days 7 and 14. Due to a technician error the body weight at death was not performed on the animal treated at a dose level of 2000 mg/kg that was humanely killed 4 hours after dosing. At the end ofthe observation period the surviving animals were killed by cervical dislocation. All animals were subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.
Statistics:
The following computerized system was used in the study:
Delta Controls - ORCA view

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths.
Clinical signs:
other: Signs of systemic toxicity noted during the day of dosing were hunched posture and ataxia. No other signs of systemic toxicity were noted.
Gross pathology:
No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight.
Executive summary:

Introduction

The study was performed to assess the acute oral toxicity of the test item in the Wistar strain rat.

Methods

Following a sighting test at dose levels of 2000 mg/kg and 300 mg/kg, a further group of four fasted females was given a single oral dose of test item, as a solution in dimethyl sulphoxide, at a dose level of 2000 mg/kg body weight. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.

Results

Mortality.  There were no deaths.

Clinical Observations.  Signs of systemic toxicity noted in the animal treated at a dose level of 300 mg/kg were hunched posture and ataxia. Hunched posture was noted in four animals treated at a dose level of 2000 mg/kg.

Body Weight.  All animals showed expected gains in body weight.

Necropsy.  No abnormalities were noted at necropsy.

Conclusion

The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight.