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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference Type:
study report

Materials and methods

Test guideline
according to guideline
other: "Appraisal of the safety of chemicals in foods , drugs and cosmetics, FDA"
Principles of method if other than guideline:
Method: according to Appraisal of the safety of chemicals in foods, drugs and cosmetics; FDA (1959)
GLP compliance:
Test type:
standard acute method
Limit test:

Test material

Constituent 1
Reference substance name:
2-Propenoic acid, 2-methyl-, C12-16-alkyl esters
EC Number:
EC Name:
2-Propenoic acid, 2-methyl-, C12-16-alkyl esters
Cas Number:
2-Propenoic acid, 2-methyl-, C12-16-alkyl esters
Test material form:

Test animals

Details on test animals or test system and environmental conditions:
- Source: SPF Wistar rats, Zucht Winkelmann, Paderborn, Germany
- Age at study initiation: no data
- Weight at study initiation: 160 - 180 g
- Fasting period before study: 16 hours
- Housing: single housing
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: no data

- Temperature (°C): 22°C
- Humidity (%): 45 - 55 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light

Administration / exposure

Route of administration:
oral: gavage
unchanged (no vehicle)
Details on oral exposure:
- Maximum dose volume applied: 3.6 ml
- Rationale for the selection of the starting dose: preliminary study for range finding
20.0 ml/kg
No. of animals per sex per dose:
5f/5m per dose
Control animals:
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighting: 20 min, 1h, 3h, 24h, 7d, 14d
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: reflexes, emotions, consciousness, central
symptoms, autonomous functions, tone

Results and discussion

Preliminary study:
No further information mentioned in the study report.
Effect levels
Dose descriptor:
Effect level:
> 17 500 mg/kg bw
Remarks on result:
other: 14 days LD50
No mortality was observed in both test groups during the observation time of 14 days.
Clinical signs:
other: Methacrylic acid ester 12.6 caused decresed activity, disturbance in coordination, diuresis and piloreaction. These symptoms were seen 30 minutes after application of the test substance and persisted for approximately 3 hours. After that time all animals
Gross pathology:
No pathological effects during the test period and observation time of 14 days.

Any other information on results incl. tables

Weight development:


 group/ number of animals  mean initial weight  mean weight after 14 -days
 I 5m/5f  168.0 g  248.0 g
 II 5m/5f  173.0 g  194.5 g

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
GHS no category.
According to the test result: LD50(14days) > 17500 mg/kg bw the test substance Methacrylic acid ester 12.6 has to be classified as nontoxic in respect of its acute oral toxicity.
Executive summary:

In an acute oral toxicity study, groups of fasted male and female SPF Wistar rats were given a single oral dose of Methacrylic acid ester 12.6 at a dose of  20.0 ml/kg/bw and observed for 14days.


Oral LD50Combined = > 20.0 ml/kg bw equals > 17500 mg/kg bw (95% C.I. not available)

GHS Category 5 ranges from 2000 -5000 mg/kg bw and represents the lowest hazard category for classifying the acute oral toxicity of a chemical substance. ("Criteria for hazard Category 5 are intended to enable the identification of the test substancese which are of relatively low acute toxicity hazard but which, under certain circumstances may present a danger to vulnerable populations". (OECD guideline 425 annex 4)).


Methacrylic acid ester 12.6 is of very low oral toxicity after oral administration based on this LD50test in males and females.

NOTE: Any of data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the same sense as a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities having paid the respective access fee for the intended purpose.