Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
2006
Report date:
2007
Reference Type:
publication
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Methacrylic acid, monoester with propane-1,2-diol
EC Number:
248-666-3
EC Name:
Methacrylic acid, monoester with propane-1,2-diol
Cas Number:
27813-02-1
Molecular formula:
C7H12O3
IUPAC Name:
1-hydroxypropan-2-yl 2-methylprop-2-enoate; 2-hydroxypropyl 2-methylprop-2-enoate
Test material form:
liquid
Details on test material:
The chemical 2-propenoic acid, 2-methyl-, monoester with 1,2-propanediol (CAS No. 27813-02-1) consists of two isomers. This occurs due to the method of industrial production, which is usually either the reaction between methacrylic acid and propylene oxide, or methacrylic acid esterification of 1,2-propanediol. The predominant isomer is the secondary alcohol 2-propenoic acid, 2-methyl, 2-hydroxypropyl ester, which is assigned the CAS No. 923-26-2, and the isomer 2-propenoic acid, 2-methyl, 2-hydroxy- 1-methylethyl ester, the other chemical in this group, for which CAS 4664-49-7 is assigned. The purification of the two isomers requires extensive effort and it is supposed no such effort has been taken during data collection otherwise noted. Therefore toxicity information for both CAS No. 923-26-2 and CAS No. 27813-02-1 is considered to be applicable to both chemicals..

Specific details on test material used for the study:
Supplier: Mitsubishi Rayon Co., LTD. (Tokyo, Japan),
Purity 98%
Lot No. 0348402.
Imputity: <=2 % of dipropylene glycol monomethacrylate
Storage conditions: in an airtight container with preventing light before use, storage at room temperature

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female
Details on test animals or test system and environmental conditions:
Details on animals:
Four weeks old Sprague-Dawley (Crj:CD(SD), SPF) rats
bought from Charles River Japan, Inc. They were put in quarantine and
acclimation for 8 days before use.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 deg C
- Humidity (%): 40-70%

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Water for injection
Details on oral exposure:
24 hour exposure
Doses:
0 (vehicle), 500, 1000, 2000 mg/kg
No. of animals per sex per dose:
5males, 5 females
Control animals:
yes
Details on study design:
Observation period: 14 days
Statistics:
Statistics Analysis: Mean body weights and their standard deviations
were calculated for every group.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 2 000 mg/kg bw
Mortality:
No mortality in any group
Clinical signs:
other:
Body weight:
other body weight observations
Remarks:
-Male and female The body weight gains of each group showed similar to that of control group during the test period.
Gross pathology:
-Male and female
--Survival animals (All animals)
No abnormalities were found in the surviving animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 was determined to be >2000 mg/kg for male and female rats.
Executive summary:

Hydroxypropyl methacrylate was tested in an acute oral toxicity test acc. OECD 401 in CD rats at concentrations of 0, 500, 1000 and 2000 mg/kg bw. 5animals per sex and dose group were tested. No mortality has been observed in any dose group. Therefore LD50 is considered to be > 2000 mg/kg.