Butyl methacrylate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

8/26/92 - 3/23/93

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

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:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Butyl methacrylate

EC Number:

202-615-1

EC Name:

Butyl methacrylate

Cas Number:

97-88-1

Molecular formula:

C8H14O2

IUPAC Name:

butyl methacrylate

Details on test material:

- Name of test material (as cited in study report): n-Butyl Methacrylate
- Lot/batch No.: H-19845
- Physical state: liquid
- Analytical purity: 99.49%
- Purity test date: no data
- Expiration date of the lot/batch: no data

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Breeding Laboratories, Kingston, New York, USA
- Age at study initiation: approximately 7 veeks old
- Weight at study initiation:
- Fasting period before study: overnight prior to dosing, with food being returned to the animals approximately 4 hours after dosing
- Housing: singly in suspended, stainless steel, vire-mesh cages
- Diet (e.g. ad libitum): Purina Certified Rodent Chow #5002
- Water (e.g. ad libitum): tap water
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 2
- Humidity (%): 50 ± 10
- Air changes (per hr): no data
- 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: 200 mg/ml
- Amount of vehicle (if gavage):  average dose volume was 2.2 ml for males and 1.7 ml for females
- Justification for choice of vehicle: solubility

MAXIMUM DOSE VOLUME APPLIED: no data

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Observations for mortality were made daily throughout the study. Rats vere weighed and observed daily for clinical signs of toxicity (veekends excluded). All rats vere subjected to gross pathological examinations at the end of the 14-day observation period.

Statistics:

Not appropriate

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

>= 2 000 mg/kg bw

Mortality:

There were no deaths

Clinical signs:

other: There were no clinical signs of toxicity

Gross pathology:

There were no adverse findings at necropsy.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: other: REGULATIONS REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008

Conclusions:

In a valid guideline study, the acute oral (gavage) LD0 in  Crl:CD BR rats was >2000 mg/kg.

Executive summary:

In an OECD 401 and GLP study, a single dose of 2000 mg/kg n-butyl methacrylate were administered by intragastric intubation to fasted male and female rats. No deaths occurred and no clinical signs of toxicity were observed within 14 days after dosing. No compound-related gross abnormalities were detected at necropsy, and no target organ was identified. This substance is considered to have an LD0 > 2000 mg/kg,when administered as a single oral dose.