Registration Dossier

Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study
Remarks:
Final report of test performed according to OECD 408 and GLP will be available on 28 February 2020
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Final report of test performed according to OECD 408 and GLP will be available on 28 February 2020.

Data source

Reference
Reference Type:
other: Final report of test performed according to OECD 408 and GLP will be available on 28 February 2020
Title:
Unnamed
Year:
2019
Report Date:
2019

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
SOURCE OF TEST MATERIAL
- Batch No.of test material:
1802161800R
- Expiration date of the batch:
16 February 2020
- Purity: 99.9752 %
- Appearance: Clear Liquid.

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
At ambient temperature (15 to 25°C), in the dark.

Results and discussion

Effect levels

Remarks on result:
other: will be provided when available

Target system / organ toxicity

Critical effects observed:
no

Applicant's summary and conclusion