[2,3'-bis[[(2-hydroxyphenyl)methylene]amino]but-2-enedinitrilato(2-)-N2,N3,O2,O3]nickel

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Short report; no GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

exeeds limit dose, female rats only

GLP compliance:

no

Remarks:

pre-dates GLP regulation

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Polysynthren Braun R

IUPAC Name:

Polysynthren Braun R

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Frankfurt, Germany
- Weight at study initiation: 204 - 220 g
- Fasting period before study: 16 h

- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum


ENVIRONMENTAL CONDITIONS
no data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Details on oral exposure:

A 25 % suspension (w/v) in sesame oil was applied.

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: regular observation and weekly weighing;
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD0

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

other: piloerection and squatting posture for less than 24 h after application.

Gross pathology:

no effects

Other findings:

none

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral LD50 was above 5000 mg/kg bw in female rats.

Executive summary:

Single oral administration (gavage) of a 25 % suspension in sesame oil of the test item to 10 female Wistar rats resulted in no martality and only minor clinical signs within 24 hours after treatment. Body weight and behavior were normal during the follwing 14 day observation period. No effects were recorded at necropsy.

The acute oral LD50 was above 5000 mg/kg bw in female rats.