Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

toxicity to reproduction
other: calculation based on mixture toxicity rules
Type of information:
calculation (if not (Q)SAR)
Migrated phrase: estimated by calculation
Adequacy of study:
weight of evidence
2 (reliable with restrictions)
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference Type:
other: software

Materials and methods

Principles of method if other than guideline:
The UVCB substance as complex substance is classified regarding Toxicity to reproduction by applying rules for classification of mixtures (EU CLP guidance section 3.7.2 pg 322ff). The classification criteria (as set out in EU CLP Guidance Annex I: 3.7.1 pg 322) can be used to estimate effects derived from that classification/hazard.

Test material

Constituent 1
Reference substance name:
sulfuric acid hydrate
EC Number:
sulfuric acid hydrate
Details on test material:
Typical across industry as defined in IUCLID Section 1.2,
See IUCLID section 1.4 for company specific elemental composition, and representative sample for mineralogical information (IUCLID section 4.23 -outotec report).

Results and discussion

Overall reproductive toxicity

Reproductive effects observed:
not specified

Any other information on results incl. tables

The calculated classification via mixture rules resulted in "Reproductive toxicity: not classified"

Applicant's summary and conclusion

Study can be used to determine Reproductive toxicity classifcation of the UVCB substance
Executive summary:

The study provided a conclusive "Reproductive toxicity: not classified" of the UVCB sample, derived on basis of the classification mixture toxicity rules for a worst case (max across industry), as defined under 1.2.

The result is therfore applicable to all Sulphuric acid, waste gas cooling and cleaning, copper smelting that fall under the therehin defined concentration ranges.

Results from calculated classification (using mixture toxicity rules) are supported (WoE) by additional consideration from phys chem properties of the UVCB substance.

The UVCB is a complex metal containing substance, which major constituents are sulphuric acic and water. Sulphuric acid is a strong mineral acid that has high affinity to water. It dissociates in water to form sulphate and hydrogen (carbonium) ions. These are the relevant forms to determine hazard properties of the substance. Arsenic was the only constituent with concentration >0.1%, this constituent triggers the acute toxicity of the substance. The maximum across industry were taken to derive the classification of the UVCB