Reaction Mass of Valencene and Aristolochene

Endpoint summary

Description of key information

Dermal reactions on day 7 reported generally slight to severe etythema, and one animal had moderate to severe eschar and edema was slight to moderate.  By day 14 erythema was generally clear and edema was clear.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Reason / purpose for cross-reference:

reference to same study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

not specified

Species:

rabbit

Strain:

New Zealand White

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

Preparation of test site:

clipped

Remarks:

clipped, intact or abraded abdominal skin

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

5,000 mg/kg bw

Duration of treatment / exposure:

24-hour contact

Observation period:

Dermal reactions were scored on days 1, 7, and 14

Number of animals:

Seven male
Three female

Details on study design:

Seven male and three female New Zealand White rabbits with initial body weights between 2.0 and 2.5 kg were treated on clipped, intact or abraded abdominal skin under occluded patches for 24-hours on contact.

Irritation parameter:

edema score

Basis:

mean

Time point:

7 d

Score:

2.5

Max. score:

3

Reversibility:

fully reversible within: 14 days

Irritation parameter:

erythema score

Basis:

mean

Time point:

7 d

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritation parameter:

edema score

Basis:

mean

Time point:

24 h

Score:

2.8

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Score:

1.4

Max. score:

2

Reversibility:

fully reversible within: 14 days

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Justification for classification or non-classification

Skin irritation was assessed on days 1, 7, and 14 by the Draize scoring system during an acute dermal LD50 study with 10 New Zealand White rabbits.  On day 1 erythema scores ranged from very slight to well defined and edema scores ranged from slight to severe.  On day 7, erythema was slight to sever on day 7 and one animal had moderate to severe eschar and edema was slight to moderate.  The CLP (EC 1272/2008) criteria for skin irritation is based on mean erythema or edema scores from gradings at 24, 28, and 72 hours, whether the inflammation persists to the end of the 14 day observation period, or where there is pronounced variability with definite positive effects in a single animal.  Based on the limited reporting of the general skin irritation observations on days 1, 7, and 14, the findings to not support the classification of valencene as a skin irritant as on average 6 out of 10 animals did not show a mean score per animal of ≥ 2.3 to ≤ 4.0 for erythema/eschar or for oedema.