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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study according to EU / OECD guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
methyl 4-cyano-2-nitrobenzoate
EC Number:
610-840-5
Cas Number:
52449-76-0
Molecular formula:
C9H6N2O4
IUPAC Name:
methyl 4-cyano-2-nitrobenzoate

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
20 males, 20 females (group 1-4, each 5 male and 5 females)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Analytical verification of doses or concentrations:
yes
Duration of treatment / exposure:
test duration: 28 days
Frequency of treatment:
daily
No. of animals per sex per dose:
Group 1: 5 males, 5 females 0 mg/kg/day ( Control animals were treated with the vehicle)
Group 2: 5 males, 5 females 62.5 mg/kg/day
Group 3: 5 males, 5 females 250 mg/kg/day
Group 4: 5 males, 5 females 1000 mg/kg/day
Control animals:
yes

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Description (incidence and severity):
no mortality, no clinical signs
Mortality:
no mortality observed
Description (incidence):
no mortality, no clinical signs
Body weight and weight changes:
no effects observed
Description (incidence and severity):
no effects on body weight
Food consumption and compound intake (if feeding study):
no effects observed
Description (incidence and severity):
no effects on food consumption
Haematological findings:
effects observed, treatment-related
Description (incidence and severity):
generally indicative if marginally increased red cell turnover with typical compensatory reaction(reticulocytosis) restricted to 1000 mg/kg/day)
Clinical biochemistry findings:
effects observed, treatment-related
Description (incidence and severity):
secondary changes in clinical biochemistry parameters: elevated mean protein and albumin values in females
Urinalysis findings:
effects observed, treatment-related
Description (incidence and severity):
Test item-related changes in the urinalysis parameters of rats treated with 1000mg/kg/day included marginally elevated bilirubin concentrations and elevated erythrocytes. These changes were accompanied by slightly higher urine volumes.
Organ weight findings including organ / body weight ratios:
effects observed, treatment-related
Description (incidence and severity):
At 1000mg/kg/day, slightly elevated liver weights were noted and considered to be typical adaptive changes. These findings correlated with the hypertrophic microscopical changes seen in the livers of some high dose animals.

Effect levels

open allclose all
Dose descriptor:
NOEL
Effect level:
250 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Based on the results 250mg/kg/day of the test item was established as NOEL and 1000mg/kg/day of the test item as the NOAEL.