Registration Dossier
Registration Dossier
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EC number: 203-453-4 | CAS number: 107-02-8
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented publication which meets basic scientific principles
Data source
Reference
- Reference Type:
- publication
- Title:
- Irritant dermatitis from diallylglycol carbonate monomer in the optical industry - Clinical and experimental studies of cutaneous tolerance and chemical investigations
- Author:
- Lacroix M, Burckel H, Foussereau J, Grosshans E, Cavelier C, Limasset JC, Ducos P, Gradinski D, Duprat P
- Year:
- 1 976
- Bibliographic source:
- Contact Dermatitis, 2 183-195
Materials and methods
- Endpoint addressed:
- skin irritation / corrosion
- Principles of method if other than guideline:
- human patch test
- GLP compliance:
- no
Test material
- Reference substance name:
- Acrylaldehyde
- EC Number:
- 203-453-4
- EC Name:
- Acrylaldehyde
- Cas Number:
- 107-02-8
- Molecular formula:
- C3H4O
- IUPAC Name:
- acrylaldehyde
- Reference substance name:
- Acrolein
- IUPAC Name:
- Acrolein
- Details on test material:
- - Name of test material (as cited in study report): Acrolein
- Analytical purity: no data
Constituent 1
Constituent 2
Method
- Ethical approval:
- not specified
- Details on study design:
- Patch tests with acrolein were carried out to determine the irritation threshold.
Patch tests with 10% acrolein were made on a second group, for histological examination (biopsied at 48 hours) - Details on exposure:
- TYPE OF EXPOSURE: patches applied on healthy skin of human subjects
TYPE OF EXPOSURE MEASUREMENT: Exposure pads
EXPOSURE LEVELS:
- Acrolein in ethanol in concentrations of 1/10 000, 1/1 000, 1/100 and 1/10 tested in 8, 10, 48 and 8 subjects, respectively.
- A further group of 10 subjects were tested with 10% acrolein in ethanol and exposed skin regions were biopsied at 48 hours.
EXPOSURE PERIOD: most probably 48 hours
POSTEXPOSURE PERIOD: no data
Results and discussion
- Results:
- Concentrations of 0.01 and 0.1 % acrolein in ethanol resulted in no skin reactions. A concentration of 1 % acrolein in ethanol resulted in 6/48 subjects in positive reactions including 4 serious oedemas with bullae and erythemas 10 mm wide. The concentration of 10% acrolein in ethanol resulted in all patch tested subjects in serious skin skin reactions with bullae.
Also in the second patch test with 10% acrolein in ethanol the epidermis was seriously. The histological examination of all 12 biopsies in the second patch test with confirmed the serious skin reactions. The skin biopsied at 48 hours showed infiltration of neutrophil polymorphonuclear leukocytes, papillary oedema and in 7 out of 12 cases necrosis or bullae of the epidermis.
Any other information on results incl. tables
Results of the first patch test with acrolein in ethanol in increasing concentrations
Concentration (acrolein/ethanol |
Number of subjects |
Number of postitive Reactions |
1/10 000 |
8 |
0 |
1/1 000 |
10 |
0 |
1/100 |
48 |
6 (incl. 4 serious oedemas with bullae and erythemas 10 mm wide) |
1/10 |
8 |
8 with bullae in several cases |
Results of the second patch test with acrolein 10 % in ethanol (biopsied at 48 hours)
No of biopsy |
Polymorph. infiltrate |
Papillary oedema |
Epidermis |
Result interpretation by the authors |
CM 375 |
+++ |
++ |
0 |
Irritation |
CM 376 |
+ |
++ |
necrosis |
|
CN 74 |
++ |
++ |
0 |
|
CN 88 |
++ |
++ |
necrosis |
|
CN 89 |
+ |
++ |
0 |
|
CN 90 |
+ |
+ |
necrosis |
|
CN 91 |
++ |
+ |
0 |
|
CN 178 |
+ |
+ |
necrosis |
|
CN 179 |
+ |
+ |
necrosis |
|
CN 346 |
0 |
+ |
bullae |
|
CN 347 |
+++ |
+ |
0 |
|
CN 348 |
++ |
++ |
bullae |
Applicant's summary and conclusion
- Conclusions:
- According to the findings of this study on human subjects, acrolein in a concentration of 10% is corrosive to the skin.
- Executive summary:
In a primary dermal irritation study, human subjects were dermally exposed to acrolein in ethanol in concentrations of 0.01, 01, 1 and 10 %. The tests were performed as patch tests.
Concentrations of 0.01 and of 0.1% induced no skin reactions in 8 and 10 volunteers, respectively. The concentration of 1 % acrolein resulted in 6/48 volunteers in positive reactions including 4 serious oedemas with bullae and erythemas 10 mm wide. The concentration of 10% acrolein in ethanol resulted in all patch tested volunteers in serious skin skin reactions with bullae.
In a second patch test with 10% acrolein in ethanol and histological examination of the skin, the histological examination of all 12 biopsies confirmed the serious skin reactions. The skin biopsied at 48 hours showed infiltration of neutrophil polymorphonuclear leukocytes, papillary oedema and in 7 out of 12 cases necrosis or bullae of the epidermis.
In this study, acrolein in a concentration of 10% is corrosive to the skin.
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