Nonan-4-olide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1972

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted similarly to OECD Guideline 401 with minor deviations: certificate of analysis not included, few details on test animals and environmental conditions, no data on number of animals showing signs of toxicity and pathological findings.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1972

Report date:

1972

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

no data on age and source of animals; no data on housing and environmental conditions, number of animals showing signs of toxicity and pathological findings

Principles of method if other than guideline:

Not applicable

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Nonan-4-olide

EC Number:

203-219-1

EC Name:

Nonan-4-olide

Cas Number:

104-61-0

Molecular formula:

C9H16O2

IUPAC Name:

5-pentyloxolan-2-one

Details on test material:

- Name of test material (as cited in study report): Compound No. 72-41
- Source: Research Institute for Fragrance Materials, Inc., New Jersey, USA
- Physical state: Clear liquid
- Date of receipt: 11 April, 1972

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 200-250 g
- Fasting period before study (minimum): 16 h
- Food and water: ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

No data

Doses:

4000, 5000, 6250, 7800 and 9700 mg/kg bw

No. of animals per sex per dose:

10 males/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Observations for mortality were made at 1 and 6 h after dosing and daily thereafter for 14 days.
- Necropsy of survivors performed: Yes

Statistics:

None

Results and discussion

Preliminary study:

None

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

6 600 mg/kg bw

Based on:

test mat.

95% CL:

5 800 - 7 400

Mortality:

- Deaths occurred overnight to two days following administration of the test material.
- Mortalities in rats were 0, 30, 40, 80 and 100 % at 4000, 5000, 6250, 7800 and 9700 mg/kg bw, respectively.

Clinical signs:

other: Piloerection and lethargy

Gross pathology:

No data

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 of γ-Nonalactone is higher than 5000 mg/kg bw in male rats therefore it is not classified according to the Directive 67/548/EEC and of the Regulation (EC) No. 1272/2008 (CLP).

Executive summary:

In an acute oral toxicity study performed similarly to OECD test Guideline No. 401, groups of Wistar rats (10 males/dose) were given a single oral dose of γ-Nonalactone at 4000, 5000, 6250, 7800 or 9700 mg/kg bw. Animals were then observed for mortality at 1 and 6 h after dosing and daily thereafter for 14 days. Gross necropsies were performed on all survivors.

Mortalities in rats were 0, 30, 40, 80 and 100 % at 4000, 5000, 6250, 7800 and 9700 mg/kg bw, respectively. Clinical signs noted were piloerection and lethargy.

Oral LD50 Males = 6600 mg/kg bw (5800-7400).

The oral LD50 of γ-Nonalactone is higher than 5000 mg/kg bw in male rats therefore it is not classified according to the Directive 67/548/EEC and the Regulation (EC) No. 1272 /2008 (CLP). This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.