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

Constituent 1
Chemical structure
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.