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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Secondary source

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
Classification and Labelling of Dangerous Substances. Recommended form to be used by the Working group on the Classification and Labelling of Dangerous Substances in order to update Annex I of Directive 67/548/EEC.
Author:
Anonymous
Year:
1993
Bibliographic source:
Commission of the European Communities DG XI
Report date:
1993
Reference Type:
secondary source
Title:
Mononitrophenols
Author:
International Programme on Chemical Safety (IPCS)
Year:
2000
Bibliographic source:
http://www.inchem.org/documents/cicads/cicads/cicad_20.htm (query result from 2011-10-14)
Reference Type:
study report
Title:
Unnamed
Year:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
Deviations:
not specified
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
2-nitrophenol
EC Number:
201-857-5
EC Name:
2-nitrophenol
Cas Number:
88-75-5
Molecular formula:
C6H5NO3
IUPAC Name:
2-nitrophenol
Details on test material:
- Name of test material (as cited in study report): o-Nitrophenol, 2-Nitrophenol
- Physical state: Solid
- Analytical purity: 99.6 %
- Impurities (identity and concentrations): ~ 0.3 % p-Nitrophenol

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
no data
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
28 days
Frequency of treatment:
no data
Doses / concentrations
Remarks:
Doses / Concentrations:
22, 67, and 200 mg/kg bw
Basis:
no data
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
- Dose selection rationale: No higher doses were administered since the authors wanted to avoid crystallisation of the test substance in the stomach.

Examinations

Observations and examinations performed and frequency:
no data
Sacrifice and pathology:
no data
Other examinations:
no data

Results and discussion

Results of examinations

Details on results:
In all groups some animals showed unspecific symptoms which were not stated as in the study protocol significant.
Food intake decreased in high-dose males and in mid- and high-dose females, and final body weight decreased non-significantly in all dosed animals.
The absolute liver and kidney weights were decreased in mid-dose animals, and the relative testes weight increased in low- and mid-dose males and decreased in high-dose males. In all dosed animals, the relative and absolute weights of the adrenal glands increased.
The haematological examination, clinical chemistry, and histopathological examination of the major organs and tissues did not give any indication of a substance-related toxic effect in comparison with controls.

Effect levels

Dose descriptor:
NOAEL
Effect level:
>= 200 other: mg/kg bw (not further specified)
Sex:
male/female
Basis for effect level:
other: see 'Remark'

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion