Registration Dossier

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:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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:
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 convulsions, clonic convulsions, erythema, exsiccosis, salivation, lacrimation, red clammy snout and eyelid, red smeared fur in the anogenital area, shaking, cramped posture and circular movement to one direction.

The surviving animals appeared normal within 9 days after application.
Body weight:
The expected body weight gain was observed in the course of the study.
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.