Reaction Mass of Valencene and Aristolochene

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 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.

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal 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:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

Seven male and three female New Zealand White rabbits with initial body weights between 2.0 and 2.5 kg.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Treated on clipped, intact or abraded abdominal skin under occluded patches

Duration of exposure:

24-hours of contact

Doses:

5,000 mg/kg bw

No. of animals per sex per dose:

Seven male
Three female

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: dermal reactions were scored on days 1, 7, and 14 and observations for mortality and/or systemic effects were made daily
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mL/kg bw

Based on:

test mat.

Mortality:

No deaths in the 10 animals tested

Clinical signs:

other: Clinical signs observed during the study included lethargy, diarrhea and few feces.

Gross pathology:

Necropsy revealed crusted or scaly skin in three animals at the treatment site.