Registration Dossier

Administrative data

Endpoint:
in vivo mammalian germ cell study: cytogenicity / chromosome aberration
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
1983
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: As reported in secondary literature source.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1983
Reference Type:
secondary source
Title:
TRIS(2-ETHYLHEXYL)BENZENE-1,2,4-TRICARBOXYLATE
Author:
OECD SIDS
Year:
2002
Bibliographic source:
SIDS Initial Assessment Report for Siam 14: TRIS(2-ETHYLHEXYL)BENZENE-1,2,4-TRICARBOXYLATE

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Dominant lethal assay.
GLP compliance:
not specified
Type of assay:
rodent dominant lethal assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals

Species:
mouse
Strain:
Strain A
Sex:
male
Details on test animals and environmental conditions:
no data

Administration / exposure

Route of administration:
other: no data
Vehicle:
no data
Details on exposure:
Guaranteed fertile males were treated by an unspecified route. This very brief account gives no further details.
Duration of treatment / exposure:
no data
Frequency of treatment:
no data
Post exposure period:
no data
Doses / concentrations
Remarks:
Doses / Concentrations:
ca. 1400 mg/kg bw (possibly per day)
Basis:
no data
Positive control(s):
METEPA, probably tris(1-(2-methyl)aziridinyl) phosphine oxide

Results and discussion

Test results
Sex:
male
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
valid
Additional information on results:
TOTM was not mutagenic when compared with the positive control (METEPA, probably tris(1-(2-methyl)aziridinyl) phosphine oxide); results
with METEPA confirmed the validity of the system.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
Based on the data reported, the test material was not clastogenic.

Classification as clastogenic is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/548/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Executive summary:

Based on the data reported, the test material was not clastogenic.

Classification as clastogenic is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/548/EEC for dangerous substances and Directive 1999/45/EC for preparations.