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Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3,3'-[[4-[(2-chloro-4-nitrophenyl)azo]phenyl]imino]bis[propiononitrile]
EC Number:
223-765-4
EC Name:
3,3'-[[4-[(2-chloro-4-nitrophenyl)azo]phenyl]imino]bis[propiononitrile]
Cas Number:
4058-30-4
Molecular formula:
C18H15ClN6O2
IUPAC Name:
3,3'-({4-[(2-chloro-4-nitrophenyl)diazenyl]phenyl}imino)dipropanenitrile
Test material form:
solid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd. Wölferstrasse 4, CH-4414 Fiillinsdorf, Switzerland
- Age at study initiation: approximately 8 weeks
- Weight at study initiation: Males: 184 - 216 grams; Females: 150 - 173 grams
- Fasting period before study: overnight fasting
- Housing: Group housing of 5 animals per sex per cage in labelled polycarbonate cages containing purified sawdust as bedding material (Woody SPF, supplied by B.M.I., Helmond, The Netherlands).
- Diet: standard pelleted laboratory animal diet (Kliba 343 from Klingentalmühle Ag, Kaiseraugst, Switzerland). ad libitum)
- Water: ad libitum
- Acclimation period: at least one week under laboratory conditions after physical examination. Only animals without any visual signs of illness were used for the study.
- Randomisation: randomly selected at time of delivery in groups of five.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 °C
- Humidity (%): 55 %
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): Lighting was 12 hours artificial fluorescent light and 12 hours dark per day

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Dosage volume: 10 mL/kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days
- Mortality / Viability: At least three times each day
- Body Weights: Test days 1 (pre-administration), 8 and 15.
- Clinical Signs: Each animal was examined for changes to treatment with particular attention paid to changes in behaviour, respiration, motility, body posture, motor susceptibility, skin, eyes, nose and fur. Observations were performed four times during day 1, and once daily during days 2 - 15. All abnormalities were recorded.
- Necropsy: Necropsies were performed by experienced prosectors. All animals were necropsied. All animals surviving to the end of the observation period were sacrificed by oxygen/carbon dioxide asphyxiation

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study period
Clinical signs:
other: No clinical signs of ill health or behavioural changes were observed during the study period
Gross pathology:
Macroscopic post mortem examination of the animals at termination did not reveal any abnormalities

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
LD50 (oral) in rat (female/male) > 2000 mg/kg bw
Executive summary:

Method

The test substance was tested for its Acute Oral Toxicity according to OECD guideline 401.

 

Observations

No mortality occurred, no clinical signs were observed and no macroscopic abnormalities were seen at necropsy. 

Results

LD50 > 2000 mg/kg bw