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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
Reliability:
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
Reference Type:
study report
Title:
Unnamed
Year:
1977

Materials and methods

Test guideline
Qualifier:
according to guideline
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:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
2-Propenoic acid, 2-methyl-, C12-16-alkyl esters
EC Number:
292-094-7
EC Name:
2-Propenoic acid, 2-methyl-, C12-16-alkyl esters
Cas Number:
90551-76-1
IUPAC Name:
2-Propenoic acid, 2-methyl-, C12-16-alkyl esters
Test material form:
liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- 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


ENVIRONMENTAL CONDITIONS
- 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
Vehicle:
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
Doses:
20.0 ml/kg
No. of animals per sex per dose:
5f/5m per dose
Control animals:
no
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
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 17 500 mg/kg bw
Remarks on result:
other: 14 days LD50
Mortality:
No mortality was observed in both test groups during the observation time of 14 days.
Clinical signs:
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 showed normal behaviour.
Body weight:
All test animals of both test groups showed normal body weight gain during the observed test period of 14 days.
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
Remarks:
GHS no category.
Conclusions:
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.

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