Registration Dossier

Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study planned (based on read-across)
Remarks:
See "Justification for type of information".
Justification for type of information:
NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out : Butylaminoethanol (CAS 111-75-1)
- Name of the substance for which the testing proposal will be used [if different from tested substance] : Dibutylethanolamine (CAS 102-81-8)

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION [please address all points below]:
- Available GLP studies : OECD 422 study conducted with the source substance Dibutylethanolamine (CAS 102-81-8)
- Available non-GLP studies : no
- Historical human data : no
- (Q)SAR : no
- In vitro methods : no
- Weight of evidence : no
- Grouping and read-across : The read-across justification is rejected by ECHA in his final decision (see section 2.0 for the reasons of the rejection in the attached final decision). Therefore, an OECD 422 study and an OECD 414 study will be conducted with the registered substance to generate substantial new evidence on its mode of action. The Registrants mentioned in their comments on ECHA's draft decision: "The Registrants propose to follow a sequential testing strategy conducting firstly the screening study (OECD 421/422) and developmental study (OECD 414) in the first species with the registered substance. Thereafter, depending on the results, the Registrants have to decide whether the 90-day study should be conducted with the registered substance or to adapt the information required for this endpoint by using read-across to DBEA, for which the 90-day study may be conducted".
- Substance-tailored exposure driven testing [if applicable] : not applicable
- Approaches in addition to above [if applicable] : not applicable
- Other reasons [if applicable] : not applicable

CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Based on the available toxicological data results, the specific adaptation possibilities of Annexes VI to X (Column 2) do not apply.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION: no

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents)
Deviations:
not applicable

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Butylaminoethanol

Results and discussion

Applicant's summary and conclusion