2-ethylhexyl methacrylate

Acute Toxicity: oral

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

Remarks:

GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylhexyl methacrylate

EC Number:

211-708-6

EC Name:

2-ethylhexyl methacrylate

Cas Number:

688-84-6

Molecular formula:

C12H22O2

IUPAC Name:

2-ethylhexyl methacrylate

Test material form:

liquid

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Details on test animals or test system 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:

other: Although soft faeces were observed in all treated groups, these effects were considered to be attributable to corn oil used as a vehicle.

Gross pathology:

No treatment related macroscopic abnormality was observed.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: other: REGULATION (EC) No 1272/2008

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 LD₀of 2-ethylhexyl methacrylate is higher than 2000 mg/kg in female/male rats.