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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
25-10-1988 - 08-11-1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
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:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Supplier: Evonik Röhm GmbH, D-64293 Darmstadt, Germany
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Stability of test article dilution: stable for at least 2 hr

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals 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
Key result
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:
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 two days after treatment .
Body weight:
For the male and also female rats there was no difference in the mean body weight between the experimental and control groups during the
whole study.
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

14

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
GHS no category.
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.

Based on the available data, Dodecyl methacrylate does not need to be classified for acute toxicity according to regulation (EC) 1272/2008.

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