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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2,3-dihydroxypropyl methacrylate
EC Number:
227-642-6
EC Name:
2,3-dihydroxypropyl methacrylate
Cas Number:
5919-74-4
Molecular formula:
C7H12O4
IUPAC Name:
2,3-dihydroxypropyl 2-methylprop-2-enoate

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Age at study initiation: 9 - 10 weeks
- Weight at study initiation: Group 1: 163-177g; Group 2: 150-156g
- Housing: group (IVC cages, type III H)
- Diet (e.g. ad libitum): ad libitum (Altromin 1324 maintenance diet for rats and mice)
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 55 +/- 10%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days (or other?)
- Other examinations performed: clinical signs, body weight, mortality, morbidity, pathology

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality.
Clinical signs:
other: Piloerection, apathy, recumbency and half-eyelid closure within the first 2-3 hours after application.
Gross pathology:
At the necropsy no treatment-related effect was observed in any animal of any step.

Any other information on results incl. tables

Step

Sex/no.

Dose (mg/kg bw)

Number of animals

Number of deaths

1

f/1-3

2000

3

0

2

f/4-6

2000

3

0

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Conclusions:
Under the conditions of the present study with test item, the LD50 was > 2000 mg/kg bw.