Reaction Mass of Valencene and Aristolochene

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Erratum to Monograph ''Valencene''

Author:

Letizia, C.S., Cocchiara, J., Wellington, G.A., Funk, C. and Api, A.M.

Year:

2001

Bibliographic source:

[Food and Chemical Toxicology 38 Supplement 3 (2000) S235-S236]. Food and Chemical Toxicology, 7(39), p.757.

Reference 2

Reference Type:

publication

Title:

Scientific opinion on Flavouring Group Evaluation 25, Revision 3 (FGE. 25Rev3): Aliphatic hydrocarbons from chemical group 31

Author:

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)

Year:

2015

Bibliographic source:

EFSA Journal, 13(4), p.4069

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

not specified

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

1

Reference substance name:

[1R-(1α,7β,8α)]-1,2,3,5,6,7,8,8a-octahydro-1,8a-dimethyl-7-(1-methylvinyl)naphthalene

EC Number:

225-047-6

EC Name:

[1R-(1α,7β,8α)]-1,2,3,5,6,7,8,8a-octahydro-1,8a-dimethyl-7-(1-methylvinyl)naphthalene

Cas Number:

4630-07-3

Molecular formula:

C15H24

IUPAC Name:

3-isopropenyl-4a,5-dimethyl-1,2,3,4,4a,5,6,7-octahydronaphthalene

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

- Weight at study initiation: between 202 and 250 g

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

unchanged (no vehicle)

Doses:

5 g/kg/body weight

No. of animals per sex per dose:

10

Details on study design:

- Duration of observation period following administration: 3-4 hours post dose and once daily thereafter for 14 days
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths in 10 animals tests

Clinical signs:

other: Clinical signs observed during the study included oily anogenital areas and isolated instances of pilorection, lethargy, chromorhinorrhea and ptosis. All animals appeared normal by day 4 with the exception of one instance of chromodacryorrhea and piloere

Gross pathology:

Goss observations at necropsy were normal for all animals.