Registration Dossier

Administrative data

Endpoint:
repeated dose toxicity: oral
Remarks:
other: calculation based on classification
Type of information:
calculation (if not (Q)SAR)
Remarks:
Migrated phrase: estimated by calculation
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: no GLP (but other Quality Assurance); software
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
other: software
Title:
Unnamed
Year:
2010

Materials and methods

Principles of method if other than guideline:
The classification criteria (as set out in EU CLP Annex I: 3.9.3.4.1.) can be used to estimate effects derived from that classification/hazard.
GLP compliance:
no
Remarks:
(other quality assurance)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Typical across industry as defined in IUCLID 1.2

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

 

The calculated classification via rules for mixtures resulted in “Specific target organ toxicity, repeated exposure" classification shown in section 2.1.

Applicant's summary and conclusion

Conclusions:
Study can be used to predict the repeated organ toxicity effect and to determine hazard/classification of the UVCB substance
Executive summary:

 

The study provided a conservative estimate of the repeated organ toxicity effect, derived on basis of the Classification outcome by applying the rules for mixtures of a Typical (across industry).