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Diss Factsheets

Toxicological information

Sensitisation data (human)

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Administrative data

sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Scientifically acceptable, well-documented study.

Data source

Reference Type:
study report
Report date:

Materials and methods

Type of sensitisation studied:
Study type:
study with volunteers
Principles of method if other than guideline:
A repeated insult patch test was performed on ambulatory volunteers, and elderly people institualised in a nursing home with 5, 2 and 1 % glutaraldehyde solution.
GLP compliance:

Test material

Constituent 1
Chemical structure
Reference substance name:
EC Number:
EC Name:
Cas Number:
Molecular formula:
Test material form:
Specific details on test material used for the study:
- Name of test material (as cited in study report): Glutaraldehyde


Type of population:
Ethical approval:
not specified
The first group were ambulatory volunteers ranging in age from 20 months to 55 years.
The second group of subjects were elderly people, both males and females, institutionalised in a nursing home. The minimum age in this group was approximately 30, the maximum age well above 70.
Route of administration:
Details on study design:
Quartered lintine discs were saturated with the test substance (5%), covered with a polypropylene film and held in place with Blenderm (3M) for approximately 24 hours. After exposure they the contact sites examined for reactions which were graded and recorded. In those cases where any reaction to the first patch was noted, the second patch was applied to a new site. In view of the severity of the reactions provoked by the first two occluded patches, the remaining applications in the series of 15 primary applications were left open (uncovered). Between applications the subjects were rested 24 hours during the week and 48 hours on the weekends. An uncovered 16th application, the challenge, was applied two weeks following the last primary application. Beginning with the sixth application of the 5% glutaraldehyde and on the same schedule, another series of occluded patches was begun on this same group. This series was started using a 1 % glutaraldehyde solution for seven patches and a 2% glutaraldehyde solution for the last three applications and the challenge.

The second group received the first in the series of patch applications identical to that of Group 1. The second patch, also occluded, was applied to a new site in all subjects immediately after removal of the first patch using the glutaraldehyde solution as received (5%). The duration of contact of this second patch was five days. Upon its removal two days were allowed for rest and observation following which the third patch in the series, also occluded, was applied to a new site using a 1 % glutaraldehyde solution. Again the contact duration was five days. Following a 24 hour rest and observation period a fourth application, again to a new site, was made. For this the 5% glutaraldehyde solution was used. The duration of contact was 24 hours, the application being left open. Following a 48 hour rest and observation period a fifth occluded application, whose duration of contact was five days, was made to a new site. For this application a 2% glutaraldehyde solution was used. Following a two week rest period 24 hour challenge applications were made simultaneously at two sites. For one site 2% glutaraldehyde on an occluded patch was used, for the other site 5% glutaraldehyde was used with the application being left uncovered.

Results and discussion

Results of examinations:
Glutaraldehyde at all concentrations and under all conditions of exposure produced a yellowish-brown discoloration and glaze at the application site. This eventually peeled off. In general, all reactions observed in this study were associated with patches which that had been attached with Blenderm and were most evident at the 5% concentration of glutaraldehyde. No reactions were evident at any concentration of glutaraldehyde used where the application was left open. This suggests that the reactions observed were artefacts and implicates the Blenderm as the source of the irritation. There was according to the authors no evidence of sensitizing action.

Applicant's summary and conclusion