Oct-7-enal

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2017-08-16 to 2017-09-12

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

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2008

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

up-and-down procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Oct-7-enal

EC Number:

244-449-2

EC Name:

Oct-7-enal

Cas Number:

21573-31-9

Molecular formula:

C8H14O

IUPAC Name:

oct-7-enal

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Chemical name: Oct-7-enal (OEL)
- CAS no.: 21573-31-9
- EC-no.: not assigned
- Source and lot/batch No.of test material: Kuraray / 82725
- Expiration date of the lot/batch: 24 April 2018
- Molecular weight: 126.198 g/mol
- Purity: 95.4%

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Females: nulliparous and non-pregnant
- Age at study initiation: 8-11 wks
- Weight at study initiation: 161-182g
- Fasting period before study:
- Housing: group housed in IVC cages
- Diet: Altromin 1324 maintenance diet for rats and mice, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 3 °C
- Humidity (%): 55 +/-10%
- Air changes (per hr): 10/h
- Photoperiod (hrs dark / hrs light): 12 h dark/ 12 h light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE
- no vehicle used, test article dosed as recieved.

MAXIMUM DOSE VOLUME APPLIED: awaiting confirmation

DOSAGE PREPARATION (if unusual):

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:

Doses:

550 mg/kg bw, 2000 mg/kg bw

No. of animals per sex per dose:

550 mg/kg bw: 1 animal
2000 mg/kg bw: 3 animals

Control animals:

no

Details on study design:

One animal was dosed first at a dose of 550 mg/kg bw. As the animal survived, the dose for the next animal was increased to 2000 mg/kg bw following the recommendations of the corresponding statistical program (EPA AOT425Statpgm).

Each animal was observed carefully for up to 48 hours before making a decision on whether and how much to dose the next animal. That decision was based on the 48-hour survival pattern of all the animals up to that time. A combination of stopping criteria was used to keep the number of animals low.

The test was stopped following the dose recommendations and criteria given in the OECD statistical program AOT425Statpgm

Statistics:

OECD statistical program AOT425Statpgm

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

All animals survived to the scheduled necropsy

Clinical signs:

The most relevant clinical findings in the animal treated with the test item at a dose of 550 mg/kg bw were reduced spontaneous activity, piloerection, half eyelid closure and alopecia.

The most relevant clinical findings in the animal treated with the test item at a dose of 2000 mg/kg bw were reduced spontaneous activity, hunched posture, piloerection and half eyelid closure.

Body weight:

No effect on body weight was observed

Gross pathology:

At necropsy, no macroscopic findings were observed in any animal.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

Under the conditions of this study the rat acute oral LD50 was > 2000 mg/kg bw in female rats. Therefore, according to Annex I for Regulation (EC) 1272/2008 the active ingredient, oct-7-enal has no obligatory labelling requirement for acute oral toxicity and is unclassified.

Executive summary:

The test article was administered undiluted orally via gavage, initially at 550 mg/kg bw to a single female using the up and down procedure. As the animal survived the dose for the next animal was increased to 2000 mg/kg bw. Each animal was observed carefully for up to 48 hours before making a decision on whether and how much to dose the next animal. That decision was based on the 48-hour survival pattern of all the animals up to that time. A combination of stopping criteria was used to keep the number of animals low. For all rats body weights were measured and a gross necropsy was performed at the end of the observation period. The most relevant clinical findings in the animal treated with the test item at a dose of 550 mg/kg bw were reduced spontaneous activity, piloerection, half eyelid closure and alopecia. The most relevant clinical findings in the animal treated with the test item at a dose of 2000 mg/kg bw were reduced spontaneous activity, hunched posture, piloerection and half eyelid closure. There were no treatment related effect on body weight and no abnormalities were recorded at necropsy in rats in either group. Under the conditions of this study the rat acute oral LD50 was >2000 mg/kg bw in female rats. Therefore, according to Annex I for Regulation (EC) 1272/2008 the active ingredient, oct-7-enal has no obligatory labelling requirement for acute oral toxicity and is unclassified.