Registration Dossier

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 guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
GLP compliance statement attached to full study report.
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals 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:
- 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, yellow discoloration of urine.
- 4 days p.a. all animals free of clinicla signs
- 2 days p.a. one male animal of the high dose group died
- 7 days p.a. one female animal showed a slight decrease in body weight, 14 day p.a. this animal regained a bosy weight above the body weight at the beginning of the study. None of the remaining animals showed any effect on body weight gain
Body weight:
One animal in the dosage group 5000 mg/kg showed 7 days p.a. slight reduction of body weight.
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.