Reaction mass of dodecyl methacrylate and tridecyl methacrylate

Acute Toxicity: oral

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:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Principles of method if other than guideline:

Groups of two male and two female Alderley Park SPF albino rats were used, bodyweight range 240-253g for males and 181-203g for females. The animals were fasted for a period of up to 24 hours immediately prior to dosing.
Preparations of the test sample, in corn oil, were then dosed at a standard volume of 10 mL/kg. On Day 1 single doses of 25, 200 and 2000 mg/kg were administered by stomach tube to separate groups of animals. The animals were observed daily up to Day 8 and then on Day 15. At the end of the study the animals were humanely killed by inhalation of excessive levels of halothane BP and were examined by necropsy for any macroscopic abnormalities. The acute oral median lethal dose was estimated from the mortality data.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Tridecyl methacrylate

EC Number:

219-671-8

EC Name:

Tridecyl methacrylate

Cas Number:

2495-25-2

Molecular formula:

C17H32O2

IUPAC Name:

tridecyl methacrylate

Constituent 2

Reference substance name:

Dodecyl methacrylate

EC Number:

205-570-6

EC Name:

Dodecyl methacrylate

Cas Number:

142-90-5

Molecular formula:

C16H30O2

IUPAC Name:

dodecyl methacrylate

Test animals

Species:

rat

Strain:

other: Alderley Park SPF albino rats

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 240-253 g (males), 181-203 g (females)
- Fasting period before study: 24 hours immediately prior to dosing

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

25, 200 and 2000 mg/kg bw

No. of animals per sex per dose:

2

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: dai1y up to Day 8 and then on Day 15
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

None of the animals died.

Clinical signs:

other: There were no significant signs of toxicity after a single oral dose of 25, 200 or 2000 mg/kg bw.

Gross pathology:

No macroscopic abnorma1ities were detected at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 of Reaction mass of dodecyl methacrylate and tridecyl methacrylate to rat was >2000  mg/kg bw .

Executive summary:

In an acute oral toxicity study, groups of fasted, young adult Alderley Park SPF albino rats 2/sex/dose were given a single oral dose of  Reaction mass of dodecyl methacrylate and tridecyl methacrylate in corn oil at doses of  25, 200 and 2000 mg/kg bw and observed for 15 days.

None of the animals died and there were no significant signs of toxicity.

Oral LD50 Males/Females >2000  mg/kg bw

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