1,2-Propanedione, 1-(2,5,5-trimethyl-1,3-dioxan-2-yl)-, 1-(O-methyloxime), (1E)-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: According to OECD 423 and GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (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: Neopentylglykol-Ketal (Stufe 3 der BAS 520 F-Synthese)
- Substance number: 98/417-1
- Batch number: 29003-138
- Degree pf purity/content: 96.2 g/100 g (H-NMR spectroscopy)
- Date of manufacturing: 1998-09-14
- Physical state/appearance: viscous, colourless-clear
- Storage conditions: room temperature, exclusion of light

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Boehringer Ingelheim Pharma KG
- Age at study initiation: young adult animals
- Weight at study initiation: 150 g - 300 g (+/- 20% of the mean weight)
- Fasting period before study:
- Housing: Stainless steel wire mesh cages, type DK-III (Becker & Co., Castrop-Rauxel, FRG)
- Diet (e.g. ad libitum): Kliba-Labordiaet, Klingentalmuehle AG, Kaiseraugst, Switzerland
- Water (e.g. ad libitum): tap water
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 h/12 h

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: several times on the day of application; at least once a day after the first day.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

One female animal died on day 2 after administration.
No mortality was seen among the male rats.

Clinical signs:

other: Signs of toxicity noted in male and female aninials comprised impaired and poor general state, dyspnoea, apathy, lateral position, staggering, ataxia, tremor, twitching, saltatory spasm, rolling convulsions, flexion spasm, extention spasm, tonic convulsio

Gross pathology:

Female that died:
General observations: postmortal state bad; Glandular stomach: hyperemia, slight; Large intestine: diseoloration of contents, black; Small intestine: discoloration of contents, black; Stomach: content, black, liquid.

Sacrificed animals: Organs without particular findings

Any other information on results incl. tables

For information on mortality, see below "Attached background material".

Applicant's summary and conclusion

Executive summary:

Under the conditions of this study the median lethal dose of Neopentylglykol- Ketal (Stufe 3 der BAS 520 F-Synthese) after oral application was found to be greater than 2000 mg/kg body weight for the male and female animals.