2,2-bis(hydroxymethyl)propionic acid

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

04 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 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

GLP compliance:

yes

Test type:

standard acute 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, group of three rats were placed in one cage (same sex groups). Surplus animals were discarded from those with outlying body weight. 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

Type of coverage:

not specified

Vehicle:

olive oil

Details on dermal exposure:

The study was carried out according to OECD guideline 402, no further information is available in the report.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 rats/sex

Control animals:

no

Details on study design:

The study followed OECD guideline 402. Rats with outlying body weights were not used in the study. A single limit dose of 2000 mg/kg bw dimethylolpropionic acid in olive oil was applied dermally to 5 male and 5 female rats. Rats were observed for 2 weeks; body weights were recorded on Day 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 observed in the study

Mortality:

No mortality occurred

Clinical signs:

other: Not reported

Gross pathology:

Necropsies were not 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	7	8	9	10
Day 1	180	185	185	180	180	195	200	200	195	205
Day 7	185	195	190	185	185	210	205	205	200	210
Day 15	190	200	195	190	195	215	215	210	210	215

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

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

Executive summary:

In an acute dermal toxicity study (conducted according to OECD TG 402), groups of 5 male and 5 female Wistar rats were dermally exposed to Dimethylolpropionic acid in olive oil for at the limit dose of 2000 mg/kg bw. Animals were then observed for 2 weeks. No deaths occurred at the limit dose during this 2 week observation period. There were no treatment related changes in body weight. The acute dermal LD50 of dimethylolpropionic acid is > 2000 mg/kg bw.