2-hydroxyethyl methacrylate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Test procedure in accordance with generally accepted scientific standards and described in sufficient detail.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Appraisal of the safety of chem by the Staff of the Division of Pharmacology, FDA, 1959 in food, drugs and cosmetics

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-hydroxyethyl methacrylate

EC Number:

212-782-2

EC Name:

2-hydroxyethyl methacrylate

Cas Number:

868-77-9

Molecular formula:

C6H10O3

IUPAC Name:

2-hydroxyethyl methacrylate

Test material form:

liquid

Specific details on test material used for the study:

Test substance: as prescribed by 1.1 - 1.4
pH: 6.0

Test animals

Species:

rat

Strain:

Wistar

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Zucht Winkelmann, Paderborn, Germany
- Age at study initiation:
- Weight at study initiation: 150 - 200 g
- Fasting period before study: 16 hrs prior to test start
- Diet (e.g. ad libitum): Laborytory standad diet: Saniff/Intermas
- Water, ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 45-55
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 6.30 ml/kg
Rationale for the selection of the starting dose: range finding test

Doses:

3.18 ml/kg = 3.40 g/kg
3.98 ml/kg = 4.26 g/kg
5.00 ml/kg = 5.35 g/kg
6.30 ml/kg = 6.74 g/kg

No. of animals per sex per dose:

5 male and 5 female

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: ca. 10 minutes, 1 h, 3 h, 24 h, 4 days, 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: body weight, reactions, emotions, nerval syptoms (i.e. tremor, ataxie, body tonus, reflexes, piloerection; body temperature

Statistics:

Litchfield & Wilcoxon, in combination with Gauß integral

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

5 564 mg/kg bw

Based on:

test mat.

Mortality:

Mortalities occured within 24 h

Group Dose 24 h 14 days
I 3.40 g/kg 1/10 1/10
II 4.26 g/kg 1/10 1/10
III 5.35 g/kg 4/10 4/10
IV 6.74 g/kg 8/10 8/10

Clinical signs:

other: After autopsy of the acute mortalities hemorraghes of the stomach- and colon mucosa where found. At test end no pathological- or anatomical changes where found in the cranium-, chest- and abdominal cavity were found.

Gross pathology:

The test substance elicted in increasing extend reduced activity, tremor , convulsion, ataxia, postural anomalies, reduced grip- and limb tonus, increased body temperature and pilo ecerection. These symptomes appeared ca. 10 minutes after application and remained partly 24 hrs. After this all survived animals showed again normal habitus during the whole observation period.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of this study, 2-hydroxyethyl methacrylate is not required to be classified for its acute toxicity potential according to EU Regulation No 1272/2008 and UN-GHS requirements, respectively.

Executive summary:

2 -Hydroxyethyl methacrylate was tested in a acute oral toxicity test in rats at concentrations up to 6740 mg/kg according to "Appraisal of the safety of chem by the Staff of the Division of Parmacology, FDA, 1959 in food, drugs and cosmetics". LD50 for acute oral toxicity was determined to be >5000 mg/kg. Therefore the substance is not classified according to EU Regulation No 1272/2008 and UN-GHS requirements, respectively.