Registration Dossier

Toxicological information

Carcinogenicity

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Administrative data

Endpoint:
carcinogenicity: oral
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only abstract available
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Title:
Unnamed

Materials and methods

Principles of method if other than guideline:
Migrated dataset. Method: other: according to US EPA TSCA Health Effects Testing Guidelines 40 CFR 798.300
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
IUCLID4 Test substance: other TS: purity 98.9 %

Test animals

Species:
mouse
Strain:
B6C3F1
Sex:
male/female

Administration / exposure

Route of administration:
oral: feed
Duration of treatment / exposure:
104 weeks
Frequency of treatment:
daily
Doses / concentrations
Remarks:
Doses / Concentrations:
150, 700, 3200 ppm
Basis:

Control animals:
yes, concurrent no treatment
Details on study design:
Post-exposure period: no

Results and discussion

Any other information on results incl. tables

Migrated dataset;

RS-Freetext:
3200 ppm: mortality at week 104: male 45/50, female 50/50
3200 ppm: hepatocellular carcinomas (m: 50/50, f: 46/50) and
adenomas (m: 2/50, f: 8/50)
700 ppm: hepatocellular carcinomas (m: 27/50, f: 28/50) and
adenomas (m: 16/50, f: 16/50)
control: hepatocellular carcinomas (m: 8/49, f: 1/50) and
adenomas (m: 4/49, f: 3/50)
NOEL  for carcinogenicity:   150 ppm
NOAEL for systemic toxicity: 150 ppm
see chapter 5.4

Applicant's summary and conclusion