2-isobutyl-4-methyltetrahydro-2H-pyran-4-yl acetate

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:

2017

Report date:

2017

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-isobutyl-4-methyltetrahydro-2H-pyran-4-yl acetate

EC Number:

942-380-9

Cas Number:

131796-64-0

Molecular formula:

C12H22O3

IUPAC Name:

2-isobutyl-4-methyltetrahydro-2H-pyran-4-yl acetate

Test material form:

liquid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Lot/batch no.: ZH 291 A1 Fr.2-4
- Expiration date of the lot/batch: 2018-08

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: young adults, ~10 weeks
- Weight at study initiation:
Group 1: 175.0 ±3.00 g
Group 2: 177.3 ±3.06 g
- Fasting period before study: Feed ~16 h before administration
- Housing: single housing in Makrolon cage, type III
- Diet: ad libitum, VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany
- Water: ad libitum, tap water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): ~10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2.08 mg/kgbw

CLASS METHOD:
- Rationale for the selection of the starting dose: request of the sponsor

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6 female

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights shortly before administration (day 0), weekly thereafter (d7) and on the last day of observation (d14).
- Necropsy of survivors performed: yes
- Other examinations performed: mortality, clinical signs, body weight

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed.

Clinical signs:

No clinical signs were observed.

Body weight:

All animals of group 1 showed a normal growth rate. In group 2, a decreased growth rate was observed in 2 out of 3 animals in the second week after administration. This effect was observed at times when the female rats have already reached slow growth age.

Gross pathology:

There were no macroscopic pathological findings in all animals sacrificed at the end of the observation period.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met