N-pentan-2-ylidenehydroxylamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Food and Consumer Product Safety Authority (VWA), Den Haag, The Netherlands

Test type:

up-and-down procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

484-470-6

EC Name:

-

Cas Number:

623-40-5

Molecular formula:

C5H11NO

IUPAC Name:

N-pentan-2-ylidenehydroxylamine

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: 9-12 weeks
- Fasting period before study: overnigh (maximaum 20 hours)
- Housing: Individually housed in Macrolon cages (Mill type, height 18 cm.) containing sterilized sawdust and paper as cage enrichment.
- Diet: ad libitum (SM R/M-Z from SSNIFF Spezialdiaten Gmbh, Soest, Germany)
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5 to 21..6
- Humidity (%): 31-80
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

175, 550, 2000 mg/kg bw

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Observations daily, body weights on Days 1, 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights

Statistics:

The LD50 was estimated based on the maximum likelihood by means of the AOT425StatPGM program.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

1 133 mg/kg bw

Based on:

test mat.

Mortality:

Yes, all rats at 2000 mg/kg

Clinical signs:

other: yes, at all dose groups

Gross pathology:

No macroscopic findings on rats that survived to the scheduled sacrifice. A pale, discolored liver was observed for one rat that was found dead on Day 2.

Other findings:

- Organ weights: Decreased liver weigts at 550 mg/kg, decreased spleen weights at >=550 mg/kg, decreased kidney weights at 2000 mg/kg

Applicant's summary and conclusion

Interpretation of results:

other: Acute Oral Cat. 4 (H302) according to Regulation (EC) No 1272/2008

Conclusions:

The oral LD50 value of 2-pentanone oxime (MPKO) in Wistar rats was estimated to be approximatley 1133 mg/kg and was found to be in the range of 300 to 2000 mg/kg body weight.