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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP, guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: liquid
Details on test material:
trans-beta-farnesene
CAS 18794-84-8

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Covance Research Products Inc., Denver, PA
- Age at study initiation: 4- 5 months
- Weight at study initiation: 2.7 - 3.0 kg
- Housing: individually housed in suspended stainless steel wire bottom cages. Paper bedding was placed beneath the cages and changed at least three times/week.
- Diet (e.g. ad libitum): Fresh PMI Rabbit Chow (Diet #5321)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.05 – 21.94 °C
- Humidity (%): 1.3 – 25.1%
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

IN-LIFE DATES: From: 1/6/09 To: 1/9/09

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml/site; neat
Duration of treatment / exposure:
4 hours
Observation period:
The test sites were scored for dermal irritation at 60 minutes after removal of wrappings. Reactions were
scored again at 24, 48 and 72 hours following patch removal
Number of animals:
3 (2 males, 1 female)
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: 4 ply surgical gauze patch. The patch was secured with non-irritating tape. The torso was wrapped with plastic in a semiocclusive manner and secured with non-irritating tape which completely covered the plastic. This method of wrapping aids in retaining the test patch in position and retards evaporation of volatile substances. The
test article was kept in contact with the skin for 4 hours at which time the wrappings were removed

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test article was removed from the test site by gently washing with distilled water
- Time after start of exposure: At the end of the exposure period, prior to scoring for dermal reactions.

SCORING SYSTEM:

Erythema & Eschar
No erythema 0
Very slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4
Edema
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well-defined by definite raising) 2
Moderate edema (raised approximately 1.0 mm) 3
Severe edema (raised more than 1.0 mm, extending beyond the area of exposure) 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
other: Study ended at 72 hours
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
other: Study ended at 72 hours
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
other: Study ended at 72 hours
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
other: Study ended at 72 hours
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
other: Study ended at 72 hours
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
other: Study ended at 72 hours
Irritant / corrosive response data:
Erythema was very slight to well defined at 60 minutes and well defined at 24, 48 and 72 hours following the 4 hour exposure. Edema was very slight to moderate at 60 minutes and slight at 24,48 and 72 hours following the 4 hour exposure.

Dermal Observations, Body Weights and Systemic Observations
Rabbit Eartag: H2035 H2017 H2077
Sex: F M M
Pretest Body Weight - kg: 3.0 2.9 2.7
Terminal Body Weight - kg: 2.9 2.9 2.6

Time after patch removal Erythema & Eschar Formation
60 minutes 1t 2t 1t
24 hours 2t 2t 2t
48 hours 2t 2t 2t
72 hours 2t 2t 2
Edema
60 minutes 2 3 1
24 hours 2 2 2
48 hours 2 2 2
72 hours 2 2 2
Systemic Observations
60 minutes A A A
24 hours A A A
48 hours A A A
72 hours A A A
A = Normal t = tape adhesive residue on dose site
Other effects:
There were no abnormal physical signs noted during the observation period.
Two animals lost weight. All other body weight changes were normal.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Not classified as skin irritant
Executive summary:

Since the test article was not expected to produce severe irritation or corrosion, three healthy New Zealand White rabbits (2 males - 1 female) were dosed dermally with trans-ß-farnesene, Lot# KJF-134-53-03, CAS# 18794-84-8. The test article (0.5 ml) was applied dermally to one intact site/rabbit and kept in contact with the skin for 4 hours at which time the wrappings were removed.

Dermal reactions were scored at 60 minutes after removal of wrappings. Reactions were scored again at 24, 48 and 72 hours following patch removal. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction at these time periods. Body weights were recorded pretest and at termination.

Erythema was very slight to well defined at 60 minutes and well defined at 24, 48 and 72 hours following the 4 hour exposure. Edema was very slight to moderate at 60 minutes and slight at 24, 48 and 72 hours following the 4 hour exposure. There were no abnormal physical signs noted during the observation period. Two animals lost weight. All other body weight changes were normal.

Dermal application of trans-ß-farnesene caused only mild skin reaction in rabbits following a 4hr semi-occlusive exposure. Skin reactions did not meet the criteria for classification as as a dermal irritant in accordance with EU CLP regulations.