Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
4 to 18 June 2007
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Recent GLP guideline compliant study, reported in summary form only

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Qualifier:
according to
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

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Dimethylolpropionic acid, obtained from VUP a.s. Prievidza.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals 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: unspecified
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:
Not reported.
Body weight:
All rats gained weight during the 2 week observation period (Table 1).
Gross pathology:
No findings reported
Other findings:
None reported.

Any other information on results incl. tables

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:
Toxicity Category V
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 of dimethylpropionic acid in Wistar rats is > 2000 mg/kg bw.
Executive summary:

Dimethylolpropionic acid was administered orally by gavage in olive oil to 3 male and 3 female Wistar rats, at the limit dose of 2000 mg/kg bw. No deaths occurred during the 2 week observation period, and all rats gained weight. Gross necropsy did not reveal any treatmnet-related findings. The acute oral LD50 of dimethylpropionic acid in Wistar rats is therefore > 2000 mg/kg bw.