2,2-bis(hydroxymethyl)propionic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

4 June 2007 to 19 June 2007

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,2-bis(hydroxymethyl)propionic acid

EC Number:

225-306-3

EC Name:

2,2-bis(hydroxymethyl)propionic acid

Cas Number:

4767-03-7

Molecular formula:

C5H10O4

IUPAC Name:

3-hydroxy-2-(hydroxymethyl)-2-methylpropanoic acid

Specific details on test material used for the study:

- Name of the test material used in the study report: Dimethylolpropionic acid
- Batch no.: not given
- Purity: not given
- Appearance: not given
- Expiry date: not given
- Storage conditions: not given

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

The animals were male and female Wistar SPF rats, obtained from Velaz Prague. Both males and females weighed 180-220 g. They were acclimatised for 7 days, during which time the health status of the rats was monitored continuously. On arrival, the rats were placed 3 to a cage (same sex groups). Surplus animals were discarded from those with outlying bodyweight. They were housed in Type T-4 cages (Velaz, Prague), cage racks and other equipment were sanitised twice a week. Potable mains tap water was supplied via glass bottles with stainless steel sipper tubes. Standard diet KKZ-P/M (ÚEF SAV, Dobrá Voda) was supplied ad libitum. The study was carried out under SPF conditions. The temperature and relative humidity of the animal rooms were maintained at 22±2°C and 30-70%. The animals were subjected to a 12 hour light: 12 hour dark cycle.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

A single dose of 2000 mg/kg bw was administered orally

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 rats/sex

Control animals:

no

Details on study design:

The study followed OECD guideline 423. Rats with outlying bodyweights were not used in the study. A single limit dose of 2000 mg/kg bw was administered to 3 male and 3 female rats. Rats were observed for 2 weeks following administration; body weights were recorded on days 1, 7 and 15.

Statistics:

Not applicable.

Results and discussion

Preliminary study:

No information available.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality at the limit dose

Mortality:

No mortality occurred.

Clinical signs:

other: Not reported.

Gross pathology:

No findings reported

Other findings:

None reported.

Any other information on results incl. tables

Table 1: Body weight changes

 

	Female Body Weights (g)			Male Body Weights (g)
Animal No.	1	2	3	4	5	6
Day 1	175	180	180	180	175	180
Day 7	185	185	180	185	185	185
Day 15	185	190	185	190	190	195

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral LD50 of dimethylolpropionic acid in Wistar rats is > 2000 mg/kg bw.

Executive summary:

In an acute oral toxicity study (conducted according to OECD TG 423), groups of 3 male and 3 female Wistar rats were given a single oral dose by gavage of dimethylolpropionic acid in olive oil at the limit dose of 2000 mg/kg bw and observed for 2 weeks. No deaths occurred during the 2 week observation period. The combined acute oral LD50 is >2000 mg/kg bw. There were no treatment related necropsy findings or changes in body weight.