Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

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:
other: Pre-guideline study. Test procedure in accordance with generally accepted scientific standards and described in sufficient detail. Comparable to guideline study with acceptable restrictions.

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 chemicals in foods, drugs and cosmetics, FDA"
Principles of method if other than guideline:
Method: in accordance with Appraisal of the safety of chemicals in food, drugs and cosmetics, FDA (1959)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Glykoldimethacrylat
- Substance type: organic
- Physical state: liquid
-Density : 1.055 g/ml (20°C)
- Analytical purity: as supplied by producer: purity in the test report not mentioned, but probably > 98,5% ; colourless liquid
- pH 6.0

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: SPF Wistar rats, Zucht Winkelmann, Paderborn, Germany
- Age at study initiation: no data
- Weight at study initiation: 145 - 225 g
- Fasting period before study: 16 hours
- Housing: 5 m, 5 w animals per group
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C
- Humidity (%): 45 - 55 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
7.94, 8.89, 10.00, 11.20, 12.60 ml/kg
No. of animals per sex per dose:
5f/5m per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighting: 20 min, 1h, 3h, 24h, 48h, 7d, 14d
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: reflexes, emotions, consciousness, central
symptoms, autonomous functions, tone

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
8 300 mL/kg bw
Based on:
test mat.
95% CL:
7.69 - 8.96
Remarks on result:
other: 14 days LD50; equals LD50: 8700 mg/kg with a density of 1.055
Mortality:
In all the dose groups mortalities occurred within 5 days. In the first group 4/10 and second dose group 7/10 animals died, in the third dose group 8/10 and in the fourth and fifths dose group 10/10 animals died after 14 days.
Clinical signs:
Dose-dependent effects e.g. decreased activity, distributed coordination, piloerection; in high dose groups: anomalous attitude, tremor; symptoms occurred 20 min after administration of TS and lasted for 24 h, after that all animals showed normal behaviour.

Any other information on results incl. tables

Table (I) Mortality (mortalities occurred within 5 days p.a.)

 group   dose  24 hours (p.a.)  14 days (p.a.)
 (I)  7.94 ml/kg  0/10  4/10
 (II)  8.89 ml/kg   3/10  7/10
 (III)  10.0 ml/kg  6/10  8/10
 (IV)  11.20 ml/kg  6/10  10/10
 (V)  12.60 ml/kg  8/10  10/10

Table(II) Weight development

group/ number of animals   mean weight (ante application; a.a.)   mean weight (post application; p.a.) after 14days
 (I) / 5f, 5m  166.0 g  190.8 g
 (II) / 5f, 5m   194.0 g  221.7 g
 (III) / 5f, 5m   177.0 g  170.0 g
 (IV) / 5f, 5m  178.5 g    - 
 (V) / 5f, 5m  168.5 g    - 

Remark: Except the animals I-9 and III-8 (very haggard animals) all the other test animals showed at the  end of the post exposure period of 14 days normal body weight gain.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
According to the test result: LD50(14days) 8700 mg/kg bw the test substance Ethylene glycol dimethacrylate has to be classified as nontoxic in
respect of its acute oral toxicity.
Executive summary:

In an pre-guideline acute oral toxicity study, groups of fasted male and female SPF Wistar rats were given a single oral dose of Ethylene glycol dimethacrylate > 98.5 % at doses of 7.94, 8.89, 10.00, 11.20 and 12.60 ml/kg bw and observed for 14 days.

 

Oral LD50Combined = 8.30 ml/kg bw equals ca. 8700  mg/kg  bw

GHS Category 5 ranges from 2000 -5000 mg/kg bw and represents the lowest hazard category for classifying the acute oral toxicity of a chemical substance. ("Criteria for hazard Category 5 are intended to enable the identification of the test substances which are of relatively low acute toxicity hazard but which, under certain circumstances may present a danger to vulnerable populations". (OECD guideline 425 annex 4)).

    

Ethylene glycol dimethacrylate is of very low oral toxicity based on this LD50 test in males and females.

NOTE: Any of data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the same sense as a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities having paid the respective access fee for the intended purpose.