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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
1973-10-24 to 1974-09-11
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Remarks:
Purity not specified, liquid containing other chemicals that might influence results

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report date:
1974

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
No specific guideline followed, but testing procedure in alignment with national standard methods.
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
N-[2-[(2,6-dicyano-4-nitrophenyl)azo]-5-(diethylamino)phenyl]acetamide
EC Number:
255-473-8
EC Name:
N-[2-[(2,6-dicyano-4-nitrophenyl)azo]-5-(diethylamino)phenyl]acetamide
Cas Number:
41642-51-7
Molecular formula:
C20H19N7O3
IUPAC Name:
N-[2-[(2,6-dicyano-4-nitrophenyl)azo]-5-(diethylamino)phenyl]acetamide
Test material form:
liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG
- Weight at study initiation: males: 80 - 88 g, females: 80 - 86 g
- Housing: 5 animals/sex were kept in plastic cages on wooden chips
- Diet (e.g. ad libitum): Altromin 1324; ad libitum
- Water (e.g. ad libitum): tap water; ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
PREPARATION OF DOSING SOLUTIONS:
The test item was formulated in water at a concentration of 5% (50 mg/mL).

VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg bw
Analytical verification of doses or concentrations:
no
Details on analytical verification of doses or concentrations:
no data
Duration of treatment / exposure:
14 days
Frequency of treatment:
once daily for 14 consecutive days.
Doses / concentrations
Dose / conc.:
500 mg/kg bw/day (nominal)
No. of animals per sex per dose:
10
Control animals:
yes, concurrent vehicle
Positive control:
not applicable

Examinations

Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily

DETAILED CLINICAL OBSERVATIONS: No

BODY WEIGHT: Yes, body weight gain was monitored

OPHTHALMOSCOPIC EXAMINATION: No

HAEMATOLOGY: Yes
- Time schedule for collection of blood: at the beginning and at the end of the study
- Anaesthetic used for blood collection: Not specified
- Animals fasted: Not specified
- Parameters checked: Haemoglobin content, erythrocytes, leukocytes, haematocrit, differential blood count and occurrence of Heinz bodies)

URINALYSIS: Yes
- Time schedule for collection of urine: at the beginning and at the end of the study
- Metabolism cages used for collection of urine: No
- Animals fasted: not specified
- Parameters checked: appearance, colour, glucose, bilirubin, protein, pH, haemoglobin, sediment



Sacrifice and pathology:
GROSS PATHOLOGY: Yes
Within 24 hours after the last application the animals were sacrificed and the organs of all animals were checked macroscopically.

HISTOPATHOLOGY: Yes,
The following organs were checked microscopically after HE- staining, PAS-and iron reaction: heart, liver, kidney, adrenal gland, lung and spleen

ORGAN WEIGHTS: yes
The following organs were weighed after sacrification: heart, lung, both kidneys, liver, spleen and adrenal glands
Statistics:
no data

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Description (incidence and severity):
No adverse signs of toxicity were observed.
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Description (incidence and severity):
The body weight gain during the entire treatment period was not affected.
Food consumption and compound intake (if feeding study):
not examined
Food efficiency:
not examined
Water consumption and compound intake (if drinking water study):
not examined
Ophthalmological findings:
not examined
Haematological findings:
no effects observed
Description (incidence and severity):
The results were comparable to the control group.
Clinical biochemistry findings:
not examined
Urinalysis findings:
no effects observed
Description (incidence and severity):
The results were comparable to the control group.
Behaviour (functional findings):
not examined
Immunological findings:
not examined
Organ weight findings including organ / body weight ratios:
no effects observed
Description (incidence and severity):
The organ weights were within the normal standard deviation range.
Gross pathological findings:
no effects observed
Description (incidence and severity):
No adverse findings were recorded.
Neuropathological findings:
not examined
Histopathological findings: non-neoplastic:
effects observed, non-treatment-related
Description (incidence and severity):
4 treated and untreated females had calcifications at the border between the renal cortex and renal medulla. Sections of the liver showed different sizes and numbers of Kupfer cells in test animals and controls.
Histopathological findings: neoplastic:
not specified
Other effects:
not examined

Effect levels

Dose descriptor:
NOAEL
Effect level:
500 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Remarks on result:
not determinable due to absence of adverse toxic effects

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The toxicity of the test item at the dosage of 500 mg/kg bw/day was investigated, when given orally to male and female Wistar rats for 14 days. Based on the results, the NOAEL can be considered to be 500 mg/kg bw/day.
Executive summary:

In a short-term repeated dose toxicity study, the test item diluted in water was administered to young adult Wistar rats (10/sex) at a dose level of 500 mg/kg bw/day. No clinical signs were observed during the study. Blood and urine analysis did not show any adverse effects. No gross pathological effects were observed. Only minor histopathological findings were recorded, which were considered to be not related to the test item treatment. Due to the absence of toxic effects, the NOAEL can be considered to be 500 mg/kg bw/day.