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Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from authoritative databases.

Data source

Referenceopen allclose all

Reference Type:
other: authoritative database
Title:
Hazardous Substances Data Bank
Author:
U.S. National Library of Medicine
Year:
2015
Bibliographic source:
HSDB
Reference Type:
review article or handbook
Title:
Summary of Data for Chemical Selection
Author:
NTP
Year:
1999
Bibliographic source:
NTP
Reference Type:
other: secondary source
Title:
Test Substance - Acute Toxicity
Author:
United States Environmental Protection Agency
Year:
2019
Bibliographic source:
HPVIS
Reference Type:
other: secondary database
Title:
Human health tier II assessment.
Author:
NICNAS
Year:
2019
Bibliographic source:
NICNAS

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
Acute dermal toxicity study of the given test chemical was performed in rabbit.
GLP compliance:
not specified
Test type:
other: Acute Dermal Toxicity
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
N,N-dimethyl-p-toluidine
EC Number:
202-805-4
EC Name:
N,N-dimethyl-p-toluidine
Cas Number:
99-97-8
Molecular formula:
C9H13N
IUPAC Name:
N,N,4-trimethylaniline
Details on test material:
- IUPAC Name: N,N-dimethyl-p-toluidine
- InChI: 1S/C9H13N/c1-8-4-6-9(7-5-8)10(2)3/h4-7H,1-3H3
- Smiles: c1(N(C)C)ccc(C)cc1
- Molecular formula :C9H13N
- Molecular weight:135.209 g/mole
- Substance type:organic
- Physical state:Liquid
- Purity: 99%

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
not specified

Administration / exposure

Type of coverage:
open
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
not specified
Duration of exposure:
not specified
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5/sex/dose
Control animals:
not specified
Details on study design:
not specified
Statistics:
not specified

Results and discussion

Preliminary study:
not specified
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed at 2000 mg/kg bw
Clinical signs:
other: not specified
Gross pathology:
not specified
Other findings:
not specified

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Conclusions:
Acute dermal toxicity dose (LD50) value was considered to be >2000 mg/kg bw, when 10 male and five female New Zealand White rabbits were treated with the given test chemical by dermal route.
Executive summary:

Acute dermal toxicity study was conducted as per OECD 402 by using the test chemical in 10 male and five female New Zealand White rabbits at the test concentration of 2000 mg/kg bw by dermal route. Animals were observed for mortality. No mortality was observed at 2000 mg/kg bw.Hence, the LD50 value was considered to be >2000 mg/kg bw, when 10 male and five female New Zealand White rabbits were treated with the test chemical by dermal route.