2,6-dichloro-N-phenylaniline

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

other information

Study period:

October 29-November 13, 1985

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Well documented and reported study, conducted according to internationally accepted technical guideline in recognized industrial research organization. A quality assurance inspection report with reference to GLP, but not a GLP compliance statement, was included in the study report.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD of 1981

Deviations:

no

GLP compliance:

no

Remarks:

but Quality Assurance statement with reference to IKS GLP guidance document was included in the report

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,6-dichloro-N-phenylaniline

EC Number:

239-349-0

EC Name:

2,6-dichloro-N-phenylaniline

Cas Number:

15307-93-4

Molecular formula:

C12H9Cl2N

IUPAC Name:

2,6-dichloro-N-phenylaniline

Details on test material:

- Name of test material (as cited in study report): PBS 3247.2
- Expiration date of the lot/batch: December 1985
- Storage conditions: room temperature
Test Article Data Sheet of September 30, 1985, Pharma Toxicology, Basle

Test animals

Species:

rat

Strain:

other: Tif:RAIf(SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Initial Age: 36 -43 days
- Number and Sex: 5 males and 5 females
- Initial Weight Range: Minimum 115 g, maximum 142 g.
- Housing: Separate sexes were housed in Macrolon cages (type IV)
- Diet: Commercially available standard diet (NAFAG No. 890, batch 81/85, analysed by the
manufacturer, NAFAG, Gossau, Switzerland).
- Water (ad libitum): Tap water. (Periodically analysed)
- Acclimation period: At least 5 days.


ENVIRONMENTAL CONDITIONS

Air conditioned room:
- Temperature (°C): 22 ± 2°C
- Relative Humidity (%): 50 ± 10%
- Photoperiod: 14 hrs artificial light/day

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 0.5% aqueous solution of Klucel HF 0.5%

Details on oral exposure:

Shortly before administration the test material was suspended in a 0.5% aqueous solution of Klucel HF 0.5% at a concentration of 25% test material in the vehicle. The animals were fasted overnight and weighed just prior to dosing. Between 08.00 and 11.00 a.m., each animal received a single oral dose by intubation (oral gavage).

Doses:

5000 (male/female) mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Symptoms and deaths were recorded daily for 14 consecutive days. At the end of the observation period, the animals were weighed and sacrificed (C02-gas evaporated from dry ice). Autopsies were performed on all animals.

Statistics:

Not applicable

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Remarks on result:

other: No deaths

Mortality:

5000 mg/kg: 0/5 (m), 0/5 (f)

Clinical signs:

other: Reduced spontaneous activity, muscular hypotonia, irregular respiration, arched backs, stiff gait. Symptoms lasted more than 360 minutes. After 24 hours no symptoms. Clinical signs noted were considered to represent a depression of the central nervous sys

Gross pathology:

Autopsies did not reveal any gross organ or tissue changes.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

In view of the oral LD50 value > 5000 mg/kg bodyweight attained in the present study, its outcome does not necessitate any labelling regarding acute oral toxicity according to EU regulations (DIRECTIVE 67/548/EEC and REGULATION (EC) 1272/2008). In addition, relevant sex-related differences in toxicity of the test material after single oral administration were not evident.

Executive summary:

PBS 3247.2 was tested for its acute toxicity by oral (gavage) in the rat according to the respective OECD Technical Guideline of 1981.

 

Reliability grade 1 was assigned to the study. It was not conducted in compliance with GLP, but a Quality Assurance statement with reference to an IKS GLP guidance document* was included in the study report.

 

The study comprised 5 male and 5 female rats treated with a limit dose of 5000 mg/kg bodyweight.

 

There were no deaths and no adverse effects on bodyweight during the 14-day observation period. Clinical signs comprised reduced spontaneous activity, muscular hypotonia, irregular respiration, arched backs and stiff gait over more than 6 hours post dose. By 24 hours after dosing all animals were free from clinical signs. Autopsy did not reveal any gross organ changes. There was no indication of relevant sex-related differences in toxicity of the test material after single oral administration.

 

Consequently, the acute oral LD50 attained in the present study is higher than 5000 mg/kg bodyweight.

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*"Wegleitung der IKS betreffend gute Laboratoriumspraxis für nichtklinische Laborversuche,

Unterabschnitt B.4.a.v."