Nonyl acetate

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: Non-GLP study conducted similarly to OECD Guideline 401 with deviations: no data about purity and no certificate of analysis of the test substance; body weight changes were not followed and gross pathology was not performed

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 about purity and no certificate of analysis of the test substance; body weight changes were not followed and gross pathology was not performed

Principles of method if other than guideline:

Not applicable

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Nonyl acetate

EC Number:

205-585-8

EC Name:

Nonyl acetate

Cas Number:

143-13-5

Molecular formula:

C11H22O2

IUPAC Name:

nonyl acetate

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): ACETATE C-9
- Physical state: Clear liquid
- Date of receipt: 1972-13-01

Test animals

Species:

rat

Strain:

other: Charles River strain

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 200-300 g
- Fasting period before study: 18 h
- Housing: Animals were housed in raised wire mesh cages.
- Diet: Regular diet of Lab Blox, ad libitum
- Water: Ad libitum

ENVIRONMENTAL CONDITIONS
- Air conditioned room

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME ADMINISTERED: 5 mL/kg bw

Doses:

5 mL/kg bw

No. of animals per sex per dose:

Five

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: No

Statistics:

None

Results and discussion

Preliminary study:

Not applicable

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 mL/kg bw

Based on:

test mat.

Remarks on result:

other: equivalent to 4350 mg/kg bw; density at 20 °C (literature): 0.87 g/cm3

Mortality:

- No mortality was observed.

Clinical signs:

other: - No visible toxic effects. - All animals consumed daily ration and behaved as normal laboratory acclimatised animals.

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 ACETATE C-9 is higher than 2000 mg/kg bw in rats therefore it is not classified according to the Directive 67/548/EEC and the CLP Regulation.

Executive summary:

In an acute oral toxicity study performed similarly to OECD Guideline 401, five male rats and five female rats of the Charles River strain were given a single oral dose of ACETATE C-9 at 5 mL/kg bw. Animals were then observed for mortality and clinical signs of toxicity for 14 days.

No mortality or visible toxic effect was observed. All animals behaved as normal laboratory acclimatised animals. In this study, the combined oral LD50 of ACETATE C-9 was considered to be higher than 5 mL/kg bw [equivalent to 4350 mg/kg bw; calculated using density at 20 °C (literature) of 0.87 g/cm3] in rats.

The oral LD50 of ACETATE C-9 is higher than 2000 mg/kg bw in rats therefore it is not classified according to the Directive 67/548/EEC and the CLP Regulation.