Octadecyl methacrylate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

25-10-1988 - 08-11-1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study OECD 401, GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

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:

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:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Wistar rats (strain: BOR: WISW (SPF TNO)), F. Winkelmann GmbH & Co KG, Borchen, Germany
- Age at study initiation: 9 weeks
- Weight at study initiation: Males: 202 - 205 ± 7-9 g; Females: 186 - 187 ± 5-7g
- Fasting period before study: overnight before test begin
- Housing: Groups of 5 in Makrolon cages
- Diet: ad libitum, Ssniff R food
- Water: ad libitum drinking water
- Acclimation period: One week under laboratory conditions


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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Doses:

5000 mg/kg b.w. and a gavage volume of 10 mL/kg b.w.

No. of animals per sex per dose:

5 males, 5 females per dose group

Control animals:

yes

Details on study design:

- Test article preparation: immediately prior to dosing
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: After administration of the test substance the rats are weighted again and held in single macrolon cages. Clinical examination was made twice a day during the length of the acute period of the intoxication, thereafter once a day.
- Necropsy of survivors performed: all animals were necropsied.
- Other examinations performed: clinical signs and symptoms, body weight, mortality, macroscopic findings
The tissues of all rats are weighted: lung, livers, kidneys, spleens, adrenals and testes; all pathological changes were recorded.

Statistics:

The t-test was the adequate statistical value for comparison the results between the experimental and control groups.

Results and discussion

Preliminary study:

The limit dose of 5000 mg/kg b.w. were applied to the rats as a range finding dose.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

Mortality was neigther observed in the experimental group nor in the controls during the observation period of 14 days.

Clinical signs:

other: The clinical appearance and behavior of the male and female rats did not differ from the controls for the whole experimental period, except of oily fouled skin in the rectum region of all experimental rats at the first day, and rough hair for the first tw

Gross pathology:

At necropsy substance-related signs of toxicity were not clearly obvious in comparison to the controls. The only observations were similar
incidences of red and white foci on the lung surface of the experimental and control rats. But in 2/5 male and 1/5 female rats slightly swollen liver
margins were observed for the experimental group only.
The results of the mean tissue weights show no differences between the experimental and control groups.

Any other information on results incl. tables

Results:

	Mortality (dead/total 5)			Time range of deaths (days)
	Male	Female	Combined
Control	0	0	0	14
5000	0	0	0	14

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

According to the test result: LD50(14days): > 5000 mg/kg bw the test substance Dodecylmethacrylate has to be classified as practically nontoxic in
rats in respect of its acute oral toxicity.

Executive summary:

In an acute oral toxicity study according to OECD guidline 401 (Limit test) with GLP, groups of fasted male and female SPF Wistar rats were given a single oral dose of Dodecylmethacrylate (purity: 97%) at a dose of 5000 mg/kg bw and observed for 14 days.

 

Oral LD₅₀ Combined = > 5000 mg/kg bw

   

Dodecylmethacrylate is oral practically nontoxic in SPF Wistar rats (OECD GHS no category) based on this LD₅₀ test in males and females.

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