Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
health surveillance data
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study meets generally accepted scientific principles, acceptable for assessment. Medical surveillance data.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2009

Materials and methods

Study type:
medical monitoring
Endpoint addressed:
skin irritation / corrosion
eye irritation
respiratory irritation
skin sensitisation
Principles of method if other than guideline:
Routine medical check up of workers involved in production of the test substance.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
(carboxylatomethyl)dodecyldimethylammonium
EC Number:
211-669-5
EC Name:
(carboxylatomethyl)dodecyldimethylammonium
Cas Number:
683-10-3
Molecular formula:
C16H33NO2
IUPAC Name:
[dodecyl(dimethyl)ammonio]acetate
Constituent 2
Reference substance name:
Cocoyl dimethyl betaine
IUPAC Name:
Cocoyl dimethyl betaine
Test material form:
other: not applicable
Details on test material:
- Name of test material (as cited in study report): Cocoyl dimethyl betaine (INCI: Coco Betaine, NAS no. 683-10-3
- Analytical purity: not specified

Method

Type of population:
occupational
Ethical approval:
not applicable
Details on study design:
Routine medical check up of 25 workers of a production plant, examined by occupational medicine department every 3 years. The last check up was carried out in 2009. Workers were examined for disorders like irritation of the respiratory tract, the eyes, skin, allergic disorders or sensitisation related to contact with the test substance.

Results and discussion

Results:
During these examinations no observations of disorders such as irritation of the respiratory tract, the eyes, the skin, allergic reactions or sensitisation have been made, which were related to the test substance.

Any other information on results incl. tables

Conclusion:

The test substance does induce irritating or sensitising effects in workers involved in the production of the substance.

Applicant's summary and conclusion