Registration Dossier

Diss Factsheets

Some information in this page has been claimed confidential.

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
calculation (if not (Q)SAR)
Adequacy of study:
key study
Study period:
2018
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
accepted calculation method

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018

Materials and methods

Principles of method if other than guideline:
Accepted calculation method. Annex 1 of the EU Regulation (EC) No 1272/2008 on the classification, labelling and packaging of substances and mixtures (CLP Regulation) contains detailed methods for calculation of data of mixtures. In general, the toxicities of the components are added up to calculate the toxicity of a mixture. The concentrations of the components are taken into account and their toxicities. For calculation purpose, the substance is regarded as a mixture of several components.
GLP compliance:
no
Remarks:
in silico study
Test type:
other: calculation
Limit test:
no

Test material

Constituent 1
Test material form:
liquid: viscous
Details on test material:
- State of aggregation: contains polymer which is not soluble after dessication
- Particle size distribution: not appropriate (liquid)
- Mass median aerodynamic diameter (MMAD): not appropriate
- Geometric standard deviation (GSD): not appropriate
- Shape of particles: not appropriate
- Surface area of particles: not appropriate
- Crystal structure: not appropriate
- Coating: not appropriate
- Surface properties: surface tension see appropriate section of IUCLID
- Density: see appropriate section of IUCLID
- Moisture content: see above
- Residual solvent: see above
- Activation: not appropriate
- Stabilisation: not required as long as treated properly and instructions of manufacturer are followed
Specific details on test material used for the study:
major constituents of the substance were tested in several published studies

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
Data calculated on basis of rat and mouse tests

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Control animals:
yes
Details on study design:
Calculation

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 250 mg/kg bw
Based on:
test mat.
Remarks on result:
other: calculation
Other findings:
The LD50 rat, acute toxicity, oral, for the substance is calculated to be > 250 mg/kg bw

Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria
Conclusions:
The calculated LD50 rat, acute toxicity, oral, for the substance is > 250 mg/kg bw