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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
Mononitrophenols
Author:
International Programme on Chemical Safety (IPCS)
Year:
2011
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:
1983

Materials and methods

Principles of method if other than guideline:
A range-finding study on maternal and developmental toxicity was conducted in rats after repeated gavage of the test material during gestation.
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): 2-Nitrophenol
No further data is given on the test material.

Test animals

Species:
rat
Strain:
other: Charles River COBS CD

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on exposure:
no data
Analytical verification of doses or concentrations:
not specified
Details on mating procedure:
no data
Duration of treatment / exposure:
from day 5 to day 15 of gestation
Doses / concentrations
Remarks:
Doses / Concentrations:
50, 125, 250, 500, and 1000 mg/kg bw
Basis:
other: not specified
No. of animals per sex per dose:
5 dams per group
Control animals:
other: yes (not further specified)

Examinations

Maternal examinations:
CAGE SIDE OBSERVATIONS: Yes

BODY WEIGHT: Yes

POST-MORTEM EXAMINATIONS: Yes

OTHER: Urine, haircoat
Ovaries and uterine content:
- Uterine examination on day 20
Fetal examinations:
no data
Historical control data:
Yes

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Maternal toxic effects:yes. Remark: dose levels of 500 and 1000 mg/kg body weight caused signs of maternal toxicity (transient but dose-related decrease in weight gain early during treatment).

Details on maternal toxic effects:
One high-dose animal died, but no cause of death could be determined. Other clinical findings included darkly coloured urine at > 250 mg/kg body weight and yellow staining of haircoat (at the nose, mouth, anogenital area) at > 125 mg/kg body weight; the necropsy findings gave no biologically meaningful differences in surviving dams. At the highest dose level of 1000 mg/kg body weight, a slight but statistically significant (also compared with historical controls) increase in group mean post-implantation losses (13.8 % versus 8.2 % in controls) and mean early resorptions (2.3 versus 1.2 in controls) was seen.

Effect levels (maternal animals)

open allclose all
Dose descriptor:
NOAEL
Effect level:
125 mg/kg bw/day
Based on:
test mat.
Basis for effect level:
other: maternal toxicity
Dose descriptor:
NOAEL
Effect level:
500 mg/kg bw/day
Based on:
test mat.
Basis for effect level:
other: developmental toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:no effects

Details on embryotoxic / teratogenic effects:
No effects were observed on the number of viable fetuses, implantations, or corpora lutea.

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion