2,2,4,4-tetramethyl-7-oxa-3,20-diazadispiro[5.1.11.2]-henicosan-21-one

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19. March - 2. May 1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

only females tested

GLP compliance:

no

Remarks:

performed before GLP implementation

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Hostavin N 20

IUPAC Name:

Hostavin N 20

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG
- Females (if applicable) nulliparous and non-pregnant: yes
- Weight at study initiation: 160-184 g
- Fasting period before study: yes, 16 h
- Housing: in groups in plastic cages, softwood pellets
- Diet (e.g. ad libitum): Altromin 1324 (Altromin GmbH, Lage/Lippe), ad libitum
- Water (e.g. ad libitum): Tap water ad libitum

IN-LIFE DATES: From: 19.3. To: 2.5.1979

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 25% test substance in 2% starch suspension

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25%
- Amount of vehicle (if gavage): 0.6 - 3.6 mL per animal

Doses:

1000, 3000 and 5000 mg/kg bw

No. of animals per sex per dose:

10 females/group

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observation for mortality/clinical signs, weekly weighing
- Necropsy of survivors performed: yes

Statistics:

LD50 calculation by Probitanalysis according to Linder and Weber

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

2 800 mg/kg bw

Based on:

act. ingr.

95% CL:

1 520 - 3 670

Mortality:

1000 mg/kg bw: 0/10
3000 mg/kg bw: 6/10
5000 mg/kg bw: 9/10

Clinical signs:

other: hunchd posture, increased breathing rate, tremor; all symptoms were reversible within 24 h

Gross pathology:

Survivors: no changes
Descedents: darkly reddened/spotted lungs and liver

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The median lethal dose of the testsubstance was 2800 mg per kg body weight. Based on the result of this study the test substance is acutely oral toxic, Cat 5.

Executive summary:

The test item was tested for its acute oral toxicity potential. 10 female rats were treated with doses of 1000, 3000, or 5000 mg/kg bw and observed for 14 days. The median lethal dose was 2800 mg per kg body weight. Based on the result of this study the test substance is acutely oral toxic, Cat 5 according to GHS criteria.