Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
other: Internal health surveillance
Adequacy of study:
key study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only abstract available: Experts´statement

Data source

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

Materials and methods

Type of sensitisation studied:
skin
Study type:
survey
Test guideline
Qualifier:
no guideline available
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Type of population:
occupational
Route of administration:
dermal

Results and discussion

Results of examinations:
SYMPTOMS / RESULT OF CASE REPORTs
- No skin sensitisation/allergic contact dermatitis observed (period ~20 years)
- Skin irritation reactions, including eczemas, due desiccative and defatting property of amorphous calcium silicate.
This skin reactions can be avoided by skin care.

EXPOSURE / JOB CATEGORY
- direct skin contact to larger amounts mainly during filling operations

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- no data

Any other information on results incl. tables

Approximately 20 years of cumulative experience in the production of synthetic amophous calcium silicate (CS) has not produced a single case of suspected contact allergy (Evonik 2009). CS like synthetic amorphous silica is known to result in drying and possibly cracking of the skin. Following prolonged exposure, this was associated with eczematous skin changes.

The implementation of technical measures resulted in steady reduction of exposure over years. Furthermore, strict personal skin protection as well as skin care succeeded in almost eliminating any case of silicate-related skin irritation.

Applicant's summary and conclusion

Conclusions:
no evidence of skin sensitising potential