Registration Dossier

Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study planned
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS
NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: 7-ACT.

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies: No GLP-study is available.
- Available non-GLP studies No non-GLP-study is available.
- Historical human data: No historical human data are available.
- (Q)SAR: No reliable and recognized QSAR-tools are available for this toxicity endpoint.
- In vitro methods: No reliable and recognized in vitro methods are available for this toxicity endpoint.
- Weight of evidence: No WoE-approach is available for this toxicity endpoint.
- Grouping and read-across: No grouping or read-across approach is available for this toxicity endpoint.
- Substance-tailored exposure driven testing: The adaption rules are not applicable for this substance.
- Approaches in addition to above: No adequate approach is known.
- Other reasons: No other reason is known.

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:
- The adaptation possibilities are not applicable.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed: The OECD-method 408 will be used.

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents)
Version / remarks:
newest.
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Ca. >= 99 % w/w

Test animals

Species:
rat
Sex:
male/female

Administration / exposure

Route of administration:
oral: feed
Analytical verification of doses or concentrations:
yes
Duration of treatment / exposure:
90 days
Frequency of treatment:
Daily once.
No. of animals per sex per dose:
According to the guideline.
Control animals:
yes, concurrent no treatment
Details on study design:
According to the guideline.
Positive control:
no

Examinations

Observations and examinations performed and frequency:
According to the guideline.
Sacrifice and pathology:
According to the guideline.
Other examinations:
According to the guideline.

Results and discussion

Applicant's summary and conclusion