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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
data is from secondary literature

Data source

Reference
Reference Type:
secondary source
Title:
Gene mutation in vivo toxicity study of the test chemical
Author:
USEPA
Year:
2018
Bibliographic source:
HPVIS

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Principles of method if other than guideline:
Bone Marrow Chromosomal Aberration was performed to determine the mutagenic nature of the test chemical in vivo.
GLP compliance:
not specified
Type of assay:
other: Bone Marrow Chromosomal Aberration

Test material

Constituent 1
Chemical structure
Reference substance name:
N,N-diethylaniline
EC Number:
202-088-8
EC Name:
N,N-diethylaniline
Cas Number:
91-66-7
Molecular formula:
C10H15N
IUPAC Name:
N,N-diethylaniline
Details on test material:
- Name of test material: Benzenamine, N,N-diethyl-
- Molecular formula: C10H15N
- Molecular weight: 149.236 g/mol
- Substance type: Organic
- Physical state: No data
- Purity: 99.73%
- Impurities (identity and concentrations): No data

Test animals

Species:
mouse
Strain:
NMRI
Remarks:
Bor: NMRI (SPF Han)
Sex:
male/female
Details on test animals or test system and environmental conditions:
No data

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
No data
Details on exposure:
No data
Duration of treatment / exposure:
No data
Frequency of treatment:
Single administration
Post exposure period:
No data
Doses / concentrations
Remarks:
0 or 600 mg/Kg/day
No. of animals per sex per dose:
No data
Control animals:
yes, concurrent vehicle
Positive control(s):
No data

Examinations

Tissues and cell types examined:
Bone marrow polychromatic and normochromatic erythrocytes
Details of tissue and slide preparation:
No data
Evaluation criteria:
The cells were observed for chromosome aberrations
Statistics:
No data

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls validity:
valid
Negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
other: No mutagenic potential
Additional information on results:
No data

Applicant's summary and conclusion

Conclusions:
The test chemical did not induce chromosome aberrations in the bone marrow cells in vivo isolated from the test chemical treated male and female NMRI mice and hence it is not likely to classify as a gene mutant in vitro.
Executive summary:

Bone Marrow Chromosomal Aberration was performed to determine the mutagenic nature of the test chemical in vivo. The study was performed using male and female Bor: NMRI (SPF Han). The test chemical was tested at dose concerntration of 0 or 600 mg/Kg/day. The animals were given a single repeated administration of the test chemical. There was an altered ratio between polychromatic and normochromatic erythrocytes. However the test chemical did not induce clastogenic effects on the cells. Based on the observations made, thetest chemical did not induce chromosome aberrations in the bone marrow cells in vivo isolated from the test chemical treated male and female NMRI mice and hence it is not likely to classify as a gene mutant in vitro.