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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Short summary of a study report from Hazleton Lab in 1984 given in a secondary source.

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
Concise International Chemical Assessment Document 20 - 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:
other: reference in secondary source
Title:
Unnamed
Year:
1984

Materials and methods

Principles of method if other than guideline:
The subacute inhalative toxicity of the test substance was tested in rats by exposure to vapour in a whole-body inhalation system for 6 h/d, 5 d/week and 4 weeks.
GLP compliance:
not specified
Limit test:
no

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): 2-Nitrophenol

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
not specified
Remarks on MMAD:
MMAD / GSD: not applicable
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE
- System of generating vapour: Melted test substance was used
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
4 weeks
Frequency of treatment:
6 hours/day, 5 days/week
Doses / concentrations
Remarks:
Doses / Concentrations:
5, 30, and 60 mg/m³
Basis:
no data
No. of animals per sex per dose:
15
Control animals:
other: Yes (not further specified)
Details on study design:
no data

Examinations

Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: Yes

HAEMATOLOGY: Yes
- Time schedule for collection of blood: After 11th exposure
- Parameters checked: Methaemoglobin values

No further details are given.
Sacrifice and pathology:
GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes

Results and discussion

Results of examinations

Details on results:
Except for squamous metaplasia of the epithelium lining the maxillo-turbinates and naso-turbinates in all high-dose animals, the clinical and histopathological examinations gave no consistent exposure-related effects.
The methaemoglobin values determined after the 11th exposure were significantly increased only in low-dose animals (males: 1.0, 2.3, 1.8, and 1.6 %; females: 2.0, 4.1, 2.1, and 1.1 %), but were within control values at the end of the study.

Effect levels

Dose descriptor:
NOAEL
Effect level:
0.06 mg/L air
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: Squamous metaplasia of the epithelium lining the maxillo-turbinates and naso-turbinates was observed in all animals of the 0.06 mg/l air dose group.

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion