Registration Dossier
Registration Dossier
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EC number: 215-710-8 | CAS number: 1344-95-2
Sensitisation data (human)
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:
- 2 009
- 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 substance name:
- Silicic acid, calcium salt
- EC Number:
- 215-710-8
- EC Name:
- Silicic acid, calcium salt
- Cas Number:
- 1344-95-2
- Molecular formula:
- CaSiO3
- IUPAC Name:
- calcium oxosilanediolate
Constituent 1
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
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