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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
Not stated
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was not conducted according to guideline/s and GLP but the report contains sufficient data for interpretation of study results

Data source

Reference
Reference Type:
publication
Title:
Contact hypersensitivity to glycerol
Author:
Hannuksela, M. and Forstrom, L.
Year:
1976
Bibliographic source:
Contact Dermatitis 2:291

Materials and methods

Type of sensitisation studied:
skin
Study type:
other:
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Study was conducted on 420 consecutive patients with eczema to determine whether glycerol was an irritant and/or sensitizer to these patients.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
No additional information available.

Method

Type of population:
other: patients with eczema
Controls:
No data.
Route of administration:
dermal

Results and discussion

Results of examinations:
No irritation was observed. One patient, out of 420 with eczema tested (0.24%), showed allergy to glycerol. This particular patient is on the staff of the allergy laboratory of the dermatological clinic in Helsinki. In january 1976, she noticed eczema on both hands. According to her own observations, a mixture of glycerol (1 part) and 70% ethanol (9 parts) applied on the hands after washing them with soap and water was the apparent cause of the ecezma. Glycerol tested at 1, 5 and 10% in water and the glycerol-ethanol mixture, as is, gave 3+ reaction at 48 and 72-hour readings. The reactions were considered to be allergic. The patient stopped using the glycerol-ethanol mixture, and the eczema disappeared within a couple of days.

Any other information on results incl. tables

No additional information available.

Applicant's summary and conclusion

Conclusions:
In a study of 420 patients with eczema, 419 showed no irritation or sensitization. One individual reportedly was sensitized but the study design does not prove that.
Executive summary:

In a study of 420 patients with eczema, 419 showed no irritation or sensitization when tested with a 50% solution in water. One individual reportedly was sensitized but the study design does not prove that.