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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
9 November 1988 - 16 November 1099
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
n/a
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Reference substance 001
Cas Number:
77-73-6
Molecular formula:
C10H12
Test material form:
liquid
Details on test material:
- Supplier: Dow Chemical Europe SA
- Batch number (Sponsor's identification): DCPD 75%
- Name of test material (as cited in study report): DCPD 75%
- Physical state: clear, yellow-coloured liquid
- Composition of test material, percentage of components: 71.1% endo dicyclopentadiene, 0.8% exo dicyclopentadiene, 1.4% m-bicyclozonadiene, 15.2% CPD-MCPD codimers, 0.3% tricyclopentadiene, 1.3% CPD-butadiene codimer, 0.3% CPD-piperylene codimer, 0.3% CPD-isoprene codimer, <0.1% benzene , remainder misc. hydrocarbons.
- Specific gravity: 0.971
- Storage condition of test material: room temperature
Specific details on test material used for the study:
- Supplier: Dow Chemical Europe SA
- Batch number (Sponsor's identification): DCPD 75%
- Name of test material (as cited in study report): DCPD 75%
- Physical state: clear, yellow-coloured liquid
- Composition of test material, percentage of components: 71.1% endo dicyclopentadiene, 0.8% exo dicyclopentadiene, 1.4% m-bicyclozonadiene, 15.2% CPD-MCPD codimers, 0.3% tricyclopentadiene, 1.3% CPD-butadiene codimer, 0.3% CPD-piperylene codimer, 0.3% CPD-isoprene codimer, <0.1% benzene , remainder misc. hydrocarbons.
- Specific gravity: 0.971
- Storage condition of test material: room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.22-2.54kg
- Housing: Individually in suspended metal cages
- Diet: Rabbit Diet ad libitum (Preston Farmers Ltd., New Leake, Boston, Lincolnshire, UK)
- Water: Mains water ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 16-22°C
- Humidity: 54-67%
- Air changes (per hr): Approximately 15/hour
- Photoperiod: 12 hrs dark / 12 hrs light):

IN-LIFE DATES: From: 9 November 1988 To: 16 November 1988

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: not specified
- Type of wrap if used: gauze patch held in place with surgical adhesive tape under a Tubigrip corset

REMOVAL OF TEST SUBSTANCE
- Washing (if done): swabbed with water
- Time after start of exposure: 4 hr after application

SCORING SYSTEM: Draize scale

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days.
Remarks on result:
other: possible hyperkeratinisation at 7 days in all 3 animals.
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
n/a
Other effects:
n/a

Any other information on results incl. tables

Skin irritation scores according to the Draize scheme

Time

Erythema (Test/Control sites)

Oedema (Test/Control sites)

 Animal number

34F

43F

80M

34F

43F

80M

after 1 hour

1

2

1

1

2

1

after 24 hours

2

2

2

4

4

3

after 48 hours

2

2

2

2

2

1

after 72 hours

2

2

2

2

2

1

mean scores 24-72h

2

2

2

2.6

2.6

1.7

Overall mean score (24-72 h)

2

2.3

Well-defined erythema persisted at all treated skin sites at 24, 48 and 72 hour observations. Signs of possible hyperkeratinisation were noted on day 7. No oedema was noted on day 7. No other adverse dermal reactions were noted during the study.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
In a skin irritation study with dicyclopentadiene 75% in rabbits, overall mean scores (24, 48 & 72 hr) were 2 for erythema and 2.3 for oedema. Dicyclopentadiene 75% was therefore considered to be a moderate irritant to rabbit skin.
Executive summary:

Skin irritation was assessed in a group of 3 New Zealand white rabbits. 0.5 mL of dicyclopentadiene 75% was applied to an area of clipped, intact skin under a semi-occlusive dressing for 4 hours. Animals were observed at 1 and 4 hours after removal of the patch and then daily for 7 days. Well-defined erythema and slight to severe oedema was present at skin sites of all rabbits at 24, 48 and 72 hour observations. On day 7 no oedema was noted but there were signs of possible hyperkeratinisation. No other adverse dermal reactions were noted during the study. The overall mean scores (24, 48 & 72 hr) were 2 for erythema and 2.3 for oedema, and the mean oedema score exceeded 2.3 for two of the three animals. DCPD 75% was a therefore considered a moderate irritant to rabbit skin, therefore, classification as H315 "causes skin irritation", according to CLP, is required.