Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The test substance, as received, was held under an impervious cuff in continuous 24-hr contact with the closely clipped skin of New Zealand White rabbits.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

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:
methacrylic acid, monoester with propane-1,2-diol
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:
- Name of test material (as cited in study report): Rocryl(TM) 410
- Purity: 99.2 %
Impurities: low boilers: 0.03 %
methacrylic acid: 0.2 %
high boilers: 99 %
propylene oxide: 5 ppm
propyleneglycol-
dimethacrylate : none detected
Inhibitor : hydroquinone monomethyl ether: 5 ppm
CB : 0.10 %
- Batch No.: JK-6673-2

Test animals

Species:
rabbit
Sex:
male

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Application: 24 hours, after the exposure time cuffs were removed and the test substance was gently wiped from the application sites with paper towels.
Duration of exposure:
24 hours
Doses:
5000 mg/kg
No. of animals per sex per dose:
6 males
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Necropsy of survivors performed: yes/no
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
0/6 animals died
Clinical signs:
other: effects observed in 6/6 animals, not further specified
Gross pathology:
effects observed in 6/6 animals, not further specified
Other findings:
Skin irritation: well defined erythema, no edema. The skin irritation was recovered on day 5 after dosing.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute dermal LD50 was determined to be >5000 mg/kg.
Executive summary:

The acute dermal toxicity of HPMA was tested in a limit test in a concentration of 5000 mg/kg in 6 New Zealand White rabbits. 0/6 animals died. LC50 dermal of HPMA is considered to be > 5000 mg/kg.