Reaction Mass of Valencene and Aristolochene

Endpoint summary

Description of key information

The acute oral LD50 in rats and acute dermal LD50 in rabbits exceeded 5,000 mg/kg bw based on no deaths in the animals tested at that dose.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

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

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

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD0

Value:

5 000 mg/kg bw

Acute toxicity: via dermal route

Link to relevant study records

Reference

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

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

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.

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD0

Value:

5 000 mg/kg bw

Justification for classification or non-classification

The acute oral LD50 in rats and acute dermal LD50 in rabbits exceeded 5,000 mg/kg bw based on no deaths in the animals tested at that dose.  Therefore, valencene does not meet the CLP (EC 1272/2008) criteria for acute toxicity.