Oct-1-yne

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

30.05 - 13.06.1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: study performed according to GLP and OECD guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Oct-1-yne

EC Number:

211-069-3

EC Name:

Oct-1-yne

Cas Number:

629-05-0

Molecular formula:

C8H14

IUPAC Name:

oct-1-yne

Details on test material:

- Physical state: colorless liquid
- Analytical purity: 98.2%
- Lot/batch No.: 18084
- Stability under test conditions: stable
- Storage condition of test material: Room temperature, stored away from light

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: BRL (Biological Research Laboratories) 4414 Fullinsdorf, Switzerland
- Weight at study initiation: M: approx.145 g, F: approx.129 g
- Fasting period before study: The animals were fasted overnight before treatment, and access to feed was given
about 3 hours after dosing.
- Housing: Macrolon® boxes, type III, with dust-free wood shaving
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +- 2°C
- Humidity (%): 50% +- 10%
- Photoperiod (hrs dark / hrs light): Fluorescent tubes, 12 hours light/dark cycle


IN-LIFE DATES: From: 30.05.1995 To: 13.06.1995

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Sodium Carboxylmethylcellulose (CMC) 5 g; Tween 80 4 ml; Benzylalcohol 5 ml; Nacl (0.9%) ad 1000 ml

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

for 2000 mg/kg: 10 animals 5 M + 5 F

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortalities: Daily; Clinical symptoms: Daily (excl. weekend); Body weight development: 2-3 times per week
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,

Results and discussion

Preliminary study:

not GLP, not seperately recorded

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: 95% CL not calculated

Mortality:

-

Clinical signs:

other: Pilo-erection was noted in all animals within a few hours after administration of 1-Octyne. Four out of ten animals were sedated shortly after treatment. All animals recovered within a few hours. No further clinical signs were noted during the observation

Gross pathology:

-

Other findings:

- Other observations: No uncommon findings were observed at scheduled necropsy.

Any other information on results incl. tables

see attachement "tables"

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Single oral administration of 2000 mg/kg body weight was
tolerated in male and female rats without notable toxicity.
The intermediate 1-Octyne can be classified as a compound which does not
present a significant acute toxic risk if swallowed, according to OECD and EU
guidelines.

Executive summary:

The acute oral toxicity of the flavour intermediate 1 -Octyne, was

investigated in 10 Wistar rats (5 M, 5 F).

Single oral administration of 2000 mg/kg body weight of 1 -Octyne was

tolerated without notable toxicity. Pilo-erection was noted in all animals within a few

hours after treatment. Four out of ten animals were sedated shortly after compound

administration. All animals quickly recovered. No further relevant findings were

noted during the observation period (14 days) or at scheduled necropsy.

The substance can be classified as a compound which does not

present a significant acute toxic risk if swallowed, according to OECD and EU

guidelines.