Registration Dossier
Registration Dossier
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EC number: 248-666-3 | CAS number: 27813-02-1
Repeated dose toxicity: other routes
Administrative data
- Endpoint:
- repeated dose toxicity: other route
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1991-07-29 to 1991-08-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Method: HPMA was administered by subcutaneous injection w 3 groups of rabbits
(10/sex/group) for 4 weeks (5 days/week) at doses of O (control), 6
mg/kg and 60 mg/kg. - GLP compliance:
- yes
- Limit test:
- no
Test material
- 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..
Constituent 1
- Specific details on test material used for the study:
- Hydroxypropyl methacrylate
Trade name of substance used in study: Rocryl® 410
Lot Number: 01581566
Purity: 97.2% active ingredient
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
Administration / exposure
- Route of administration:
- subcutaneous
- Vehicle:
- water
- Details on exposure:
- HPMA was administered by subcutaneous injection w 3 groups of rabbits
(10/sex/group) for 4 weeks (5 days/week, Monday-Friday) at doses of O (control), 6
mg/kg and 60 mg/kg. Sterile water for injection served as the vehicle for the test
material. - Duration of treatment / exposure:
- 4 weeks
- Frequency of treatment:
- Single daily injections, 5 days/week
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day
- Remarks:
- control
- Dose / conc.:
- 6 mg/kg bw/day
- Dose / conc.:
- 60 mg/kg bw/day
- No. of animals per sex per dose:
- 10/sex/dose
- Control animals:
- yes, concurrent vehicle
Results and discussion
Results of examinations
- Details on results:
- No treatment-related deaths occurred and no clinical signs indicative of a
treatment-related toxicological effect were evident. No adverse effects on body weight
or feed consumption were observed over the course of the study. Clinical observations
revealed treatment-related cutaneous lesions characterized by scabs and thickening of the
skin surface in rabbits administered the highest dose of HPMA (60 mg/kg). Treatmentrelated
gross necropsy findings included scabs, sores and thickening of the skin in the
high dose group only.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- > 60 other: mg/kg
- Sex:
- male/female
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
No treatment related deaths. No clinical signs. Thickening
of the skin, scrabs and scores in the 60 mg/kg/day group. No
systemic toxicity. NOAEL for systemic toxicity > 60
mg/kg/day.
Applicant's summary and conclusion
- Conclusions:
- HPMA did not produce systemic toxicity when administered to rabbits over four
weeks (5 days/week, Monday-Friday) by subcutaneous injection at doses up to 60 mg/kg.
Evidence of treatment-related local irritation was observed at 60 mg/kg HPMA but not at
6 mg/kg. Under the conditions of this study, the NOEL for systemic toxicity is 60 mg/kg.
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