Acrylaldehyde

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:

1976

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

Test material information

Constituent 1

Reference substance name:

Acrylaldehyde

EC Number:

203-453-4

EC Name:

Acrylaldehyde

Cas Number:

107-02-8

Molecular formula:

C3H4O

IUPAC Name:

acrylaldehyde

Constituent 2

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

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.