1-chloro-2,5-dimethoxy-4-nitrobenzene

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1986-02-19 to 1986-03-17

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well documented GLP and guideline study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

GLP compliance statement attached to full study report.

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1-chloro-2,5-dimethoxy-4-nitrobenzene

EC Number:

230-086-7

EC Name:

1-chloro-2,5-dimethoxy-4-nitrobenzene

Cas Number:

6940-53-0

Molecular formula:

C8H8ClNO4

IUPAC Name:

1-chloro-2,5-dimethoxy-4-nitrobenzene

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Strain: Hoe: WISKf(SPF71)
- Source: Hoechst AG, Kastengrund, SPF breed
- Weight at study initiation:
males: mean = 215.3 +/- 9.24 g (min: 200 g, max: 232 g)
males: mean = 176.6 +/- 6.29 g (min: 170 g, max: 188 g)
- Age at study initiation: males and females: approx. 8 weeks
- Randomisation: according to procedures 91/86 and 92/86
- Housing in air conditioned rooms in groups of 5 animals
- Temperature: 22 +/- 3 °C
- Rel. humidity: 50 +/- 20 %
- Lighting: 12 hrs daily
- Acclimatisation period: min 5 days
- Fasting before dosing: 16 hrs before and 3-4 hrs after administration.
- Diet: Rat diet Altromin 1324, ad libitum
- Water: tap water, ad libitum
- Labelling: Labelling of fur with KMnO4 as well as numbering of cages

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Details on oral exposure:

- Concentration in vehicle: 25 % (w/v)
- Amount of vehicle (if gavage): 10 and 20 ml/kg bw, respectively

Doses:

2500, 5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Observation time after administration: 14 days
- Weekly determination of animal body weight
- Necropsy of dead animals as well as animals sacrificed after end of study.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

2500 mg/kg bw: None.
5000 mg/kg bw: one male

Clinical signs:

other: - The following symptoms were observed in males as well as females up to 3 days p.a.: reduced activity, ruffeled fur, retracted flanks, crouched position, uncoordinated walk, abdominal position, lateral position, increased breathing rate, clonic spasm, ye

Other findings:

The male animal was eroded and was for that reason not weighted and dissected.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Executive summary:

Acute oral toxicity of 1 -chloro-2,5 -dimethoxy-4 -nitrobenzene was tested according to OECD 401. Two doses were tested, 2000 mg/kg body weight and 5000 mg/kg body weight. Administration was via oral gavage, sesame oil was used as vehicle. No mortality was observed at 2500 mg/kg body weight, at 5000 mg/kg body weight one male animal died. Taken together the LD50 was determined to be greater than 5000 mg/kg body weight. Among the clinical effects observed were unspecific symptoms of intoxication, reduced activity, ruffeled fur, retracted flanks, crouched position, uncoordinated walk, abdominal position, lateral position, increased breathing rate, clonic spasm and a yellow discoloration of urine. Four days p.a. all observed symptoms were reversible. One animal showed a slight decrease in body weight after seven days, however, fourteen days after exposure the body weight was increased above the body weight at the beginning of the study. Following the provisions laid down in 83/467/EEC 1-chloro-2,5-dimethoxy-4-nitrobenzene is not classified as acute toxic via oral route of exposure.