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Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
GLP
Justification for type of information:
Read across from the 2 Ethylhexyl methacrylate category member donor substance.
REPORTING FORMAT FOR THE CATEGORY APPROACH
see attached category document
PM_Lower Alkyl (C1-C8) Methacrylates
This is a category (C1-C8 Lower Alkyl Methacrylates) with clear trends in the physicochemical properties of its members, related to molecular weight, molecular size and hydrophilicity.
Reliable data are available for all members of the category except n-octyl methacrylate. The more recent studies were conducted to modern guidelines up to the limit dose of 2000 mg/kg.
The substances of the category C1-C8 Lower Alkyl Methacrylates are all of low acute oral toxicity. This was demonstrated in several guideline studies which cover the range of C1 to C8. Please see Chapter 5.2.1.1 Summary of Acute Oral Toxicity Data

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Japan Co. (Hino Breeding Center)
- Age at study initiation:
- Weight at receipt: 113-120g for males and 95-106 for females
- Fasting period before study: yes
- Housing: Stainless steel cage systems (W: 240 x D: 380 x H: 200mm) were used during quarantine and acclimatization, and 5 rats were housed in each cage. After dividing into groups, a rack of five stainless steel cages (W: 755 x D: 210 x H: 170mm) were used for individual housing.
- Diet (ad libitum): CRF-1, Oriental Yeast Co.
- Water (ad libitum): tap water
- Acclimation period: 12 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23
- Humidity (%): 45-53
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0, 50, 100 or 200 mg/ml
- Amount of vehicle (if gavage): 5 ml/kg
- Justification for choice of vehicle: solubility
Doses:
0 (vehicle), 500, 1000, 2000 mg/kg/day
No. of animals per sex per dose:
five
Control animals:
yes
Details on study design:
Post dose observation period: 14 days
- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Weighing: Days 1, 3, 7, 10 and 14
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Mortality:
There were no deaths in any group
Clinical signs:
Although soft faeces were observed in all treated groups, these effects were considered to be attributable to corn oil used as a vehicle.
Body weight:
A tendency of the depression of body weight gain was observed on the second day in both sexes.
Gross pathology:
No treatment related macroscopic abnormality was observed.

Applicant's summary and conclusion

Conclusions:
The LD0 value was more than 2000 mg/kg for males and females.
Executive summary:

The Acute oral toxicity of 2-ethylhexyl methacrylate was evaluated in male and female Crj: CD(SD) rats according to OECD N°401 guideline and in compliance with principles of Good Laboratory Practices. Animals were treated by gavage at the dose level of 2000 mg/kg and then observed for 14 days for mortality, clinical signs and effect on body weight. No mortality was recorded in the 14 day-observation period. Although soft faeces were observed in all treated groups, these effects were considered to be attributable to corn oil used as a vehicle. A tendency of the depression of body weight gain was observed on the second day in both sexes. No treatment related macroscopic abnormality was observed. Under these experimental conditions, the oral LD0 of 2-ethylhexyl methacrylate is higher than 2000 mg/kg in female/male rats.