Reaction products of acetic acid with formaldehyde and a mixture of 1-, 2-, 3-,octene

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April - June 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

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:

Tetrahydro-3-pentyl-2H-pyran-4-yl acetate

EC Number:

242-640-5

EC Name:

Tetrahydro-3-pentyl-2H-pyran-4-yl acetate

Cas Number:

18871-14-2

Molecular formula:

C12H22O3

IUPAC Name:

3-O-acetyl-1,5-anhydro-2,4-dideoxy-2-pentylpentitol

Constituent 2

Reference substance name:

3-butyltetrahydro-5-methyl-2H-pyran-4-yl acetate

EC Number:

253-863-2

EC Name:

3-butyltetrahydro-5-methyl-2H-pyran-4-yl acetate

Cas Number:

38285-49-3

Molecular formula:

C12H22O3

IUPAC Name:

3-O-acetyl-1,5-anhydro-2-butyl-2,4-dideoxy-4-methylpentitol

impurity 1

Reference substance name:

3-pentyltetrahydro-2H-pyran-4-ol

Cas Number:

24646-98-8

Molecular formula:

C10H20O2=

IUPAC Name:

3-pentyltetrahydro-2H-pyran-4-ol

impurity 2

Reference substance name:

Likely acetylated constituents, MW 214

Molecular formula:

n/a

IUPAC Name:

Likely acetylated constituents, MW 214

impurity 3

Reference substance name:

Likely acetylated constituents

Molecular formula:

n/a

IUPAC Name:

Likely acetylated constituents

impurity 4

Reference substance name:

Unknown constituent, MW 172

Molecular formula:

n/a

IUPAC Name:

Unknown constituent, MW 172

Test material form:

liquid

Details on test material:

UVCB substance

Specific details on test material used for the study:

Batch no.: PE00138468
Expiry date : 20 February 2018

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

Age : 6-7 weeks old
Weight range at arrival : 168.3-189.3 grams

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

300 mg/kg
2000 mg/kg

No. of animals per sex per dose:

3

Control animals:

no

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 and no clinical signs were observed in animals of the first group initially dosed at 300mg/kg (Group 12, Step 1). No mortality occurred and no clinical signs were seen in the further group of 3 females dosed at the same dose level (Group 21, Step 2) and in the two groups of 3 females each dosed at 2000mg/kg (Group 24, Step 3; Group 27, Step 4).

Clinical signs:

No mortality and no clinical signs were observed in animals of the first group initially dosed at 300mg/kg (Group 12, Step 1). No mortality occurred and no clinical signs were seen in the further group of 3 females dosed at the same dose level (Group 21, Step 2) and in the two groups of 3 females each dosed at 2000mg/kg (Group 24, Step 3; Group 27, Step 4).

Body weight:

Changes in body weight observed during the study were within the expected range for this strain and age of animals.

Gross pathology:

No abnormalities were observed at necropsy examination performed on all animals dosed at 300 and 2000mg/kg (Groups 12, 21, 24 and 27) at the end of the observation period.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Executive summary:

The acute toxicity of JASMONYL LG was investigated following a single oral administration at the doses of 300 and 2000mg/kg (10mL/kg in 0.5% aqueous solution of carboxymethylcellulose) to the Sprague Dawley rat followed by a 14-day observation period.

No mortality occurred and no signs of toxicity were observed in the 6 animals following dosing at 2000mg/kg.

These results indicate that the test item JASMONYL LG did not induce toxic effects in the rat following oral administration of a single dose at a level of 2000mg/kg. The lack of mortality demonstrates the acute toxicity expected (ATE) to be greater than 2000mg/kg body weight.