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Toxicological information

Acute Toxicity: oral

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
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 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
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:
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.
Body weight:
Group initial body weight body weight after 14 days
I 173.5 g 222.8 g
II 172.5 g 224.4 g
III 173.5 g 225.8 g
IV 161.5 g 227.5 g
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:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: other: UN-GHS
Conclusions:
Based on the results of this study, 2-hydroxyethyl methacrylate is not required to be classified for its acute toxicity potential according to 67/548/EEC and UN-GHS requirements, respectively.
Executive summary:

2 -Hydroxyethyl methacrylate was tested in a acute oral toxicity test with rats in 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". The LD50 larger 5000 mg/kg. Therefore the substance is not classified according to 67/548/EEC and UN-GHS requirements, respectively.