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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

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:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

USA EPA Guidelines OPPTS 870.1200

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

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:

DINOL, CAS number 3296-90-0, White crystalline solid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

No of animals: Five males and five females, females nulliparous and non pregnant.
Weight: 200g at start of the study, weight variation did not exceed ± 20% of the mean weight for each sex.
Age: eight to twelve weeks of age.
The diet, drinking water and bedding was routinely analysed.
Husbandary: Housed individually during 24-hour exposure period and in groups of five, by sex, for the reminder of the study.
Temp: 19-25°C, Relative humidity: 30-70%

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

A piece of surgical gauze was placed over the treatment area and semi-occluded with a piece of self adhesive bandage. After 24 hour contact period
the bandage was carefully removed and the treated skin and surrounding hair wiped with cotton wool moistened with distilled water to remove any residual test material.

Duration of exposure:

24 hour exposure period

Doses:

500 mg/kg

No. of animals per sex per dose:

5 male, 5 female

Control animals:

not required

Details on study design:

The animals were observed for deaths or over signs of toxicity 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days.
At the end of the study the animals were killed by cervical dislocation. All animals were subjected to gross necroscopy. This consisted of an external examination and opening of the abdominal and thoractic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues
were retained.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

There were no deaths

Clinical signs:

other: no signs of systemic toxicity

Gross pathology:

No abnormalities were noted at necroscopy

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information

Conclusions:

The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was found to be greater than 5000 mg/kg
bodyweight.