1,1'-Biphenyl, 4'-chloro-2-nitro-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Details on test material:

- name of the test substance: Nitrobiphenyl (Reg.Nr. 363 986)
- Purity: 95.5 area%
- batch number: 27997/111 Fr.5
- CAS number: 6271-80-3
- date of manufacturing: 1997-03-11
- physical state/appearance: liquid, red-clear
- storage: room temperature

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

- Young adult animals with a comparable weight were used.
- Acclimatization for at least 1 week.
- One animal per cage (type: stainless steel wire mesh cages, type DK-III).
- The animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a range of 20 - 24°C for temperature and of 30 - 70% for relative humidity. The day/night rhythm was 12 h light and 12 h darkness.
- Individual animal identification using cage cards and group identification by tail marking.
- The animals were offered a standardized animal laboratory diet as well as tap water ad libitum. The animals were given no feed at least 16 hours bef ore administration, but water was available ad libitum.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

Good solubility in olive oil DAB 10.
Form of administration: solution
Concentrations used: 4 or 40 g/100 ml
Application volume: 5 ml/kg

Doses:

200 and 2000 mg/kg

No. of animals per sex per dose:

3 males (200 and 2000 mg/kg); 3 females (200 mg/kg)

Control animals:

no

Details on study design:

Observation period: 200 mg/kg - 14 days; 2000 mg/kg - 2 days
Individual body weight determination shortly before administration (day 0), weekly thereafter and at the end of the study (before fasting period).
Recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals.
A check for any dead or moribund animal was made twice each workday and once on Saturdays, Sundays and on public holidays.
Necropsy at the last day of the observation period. Withdrawal of food at least 16 hours before sacrifice with CO2; then necropsy with gross pathology examination. Necropsy of all animals that died before as early as possible.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 200 - <= 2 000 mg/kg bw

Mortality:

200 mg/kg: males and females: no deaths
2000 mg/kg: males 3/3 after 2 days

Clinical signs:

other: Male and female animals - 200 mg/kg: no symptoms Male animals - 2000 mg/kg: poor general state, dyspnea, apathy, abdominal and lateral position, staggering, ataxia, atonia, paresis, tremor, spastic gait, erythema, piloerection, smeared fur, exsiccosis, ex

Gross pathology:

Animals that died:
2000 mg/kg: glandular stomach: erosion/ulcer, few, diameter up to 2 mm, black; jejunum: discolouration, black: 1 male; stomach: hyperemia, moderate; glandular stomach: erosion/ulcer, few, diameter 2 mm, black; Intestine: discolouration, dark red: 1 male; glandular stomach: erosion/ulcer, few, diameter 1 mm, black; intestine: discolouration, black: 1 male; postmortal state moderate: 2 males
Sacrificed animals:
200 mg/kg: organs without particular findings: 3 males, 3 females

Applicant's summary and conclusion

Conclusions:

Based on the results of this study, the test substance needs to be classified R22 and acute oral toxicity Cat. 4, according to Directive 67/548/EEC and Regulation (EU) No. 1272/2008, respectively.