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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:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from safety assessment report

Data source

Reference
Reference Type:
secondary source
Title:
DCPD 75% - ACUTE DERMAL IRRITATION TEST IN THE RABBIT, WITH COVER LETTER DATED 11/2/95 (SANITIZED)
Author:
NTRL
Year:
1995
Bibliographic source:
NTRL REPORT- OTS0558246; NOVEMBER 28 1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
Skin irritation study of Dicyclopentadiene (CAS no: 77-73-6) was conducted on three New Zealand White rabbits to observe its irritation efficacy in accordance with OECD Guidelines No. 404 -Acute Dermal irritation /Corrosion.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): Dicyclopentadiene
- Molecular formula: C10H12
- Molecular weight: 132.2048 g/mol
- Substance type: organic
- Physical state: liquid
- InChI: C1C=CC2C1C3CC2C=C3
- Smiles: 1S/C10H12/c1-2-9-7-4-5-8(6-7)10(9)3-1/h1-2,4-5,7-10H,3,6H2

Specific details on test material used for the study:
- Name of test material (as cited in study report): Dicyclopentadiene
- Molecular formula: C10H12
- Molecular weight: 132.2048 g/mol
- Substance type: organic
- Physical state: liquid
- InChI: C1C=CC2C1C3CC2C=C3
- Smiles: 1S/C10H12/c1-2-9-7-4-5-8(6-7)10(9)3-1/h1-2,4-5,7-10H,3,6H2
- Purity: 75%
- Impurities: 25%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dayid Percival ltd., Maston, Sanclbach. Chuhire, U.K. A
- Age at study initiation: approxt.tely twelve to sixteen weeks old
- Weight at study initiation: 2.22 - 2.54 kg-
- Housing: individually housed 1n suspended metal cages
- Diet (e.g. ad libitum): Rabbit diet. ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: five days


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

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Remarks:
Intact skin
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
0.5ml

Duration of treatment / exposure:
4 hours
Observation period:
Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: dorsal flank area
- Type of wrap if used: 2.5 cm x 2.5 gauze patch. The patch was secured in position with a strip of surgical adhesive Tape. to Prevent t he animals
from interfering with the patches, the trunk of each rabbit was wrapped in
an elasticted corset and the animals were returned to their cages for the duration of the exposure period.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): any residual test removed by gentle swabbing with cotton wool soaked in distilled water followed by diethyl ether
- Time after start of exposure:1hour

SCORING SYSTEM: according to Draize scoring system. The results were also interpreted according to the E.E.C. Directive of 29 July 1983 83/467/EEC adapting Council Directive 67/548/EEC on the regulations relating to the classification, packaging and labelling of dangerous substances.

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
7 d
Score:
4.7
Max. score:
8
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
Well-defined erythema was observed within 3 days of exposure in all animals. Signs of keratinization were observed on day 7. Moderate edema was observed at 24 hours in all animals, and regressed to slight by day 3. No corrosive effects were observed.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
The Primary irritation index of 4.7 was observed for test material Dicyclopentadiene (CAS no: 77-73-6). therefore Dicyclopentadiene was considered to be moderately irritating to the skin of New Zealand White rabbits .
Executive summary:

Skin irritation study of Dicyclopentadiene (CAS no: 77-73-6) was conducted on three New Zealand White rabbits to observe its irritation efficacy in accordance with OECD Guidelines No. 404 -Acute Dermal irritation /Corrosion.

 

In this study, 0.5ml ofDicyclopentadienewas applied to intact skin locations on the backs of each rabbits for four hours semi-occlusive condition and skin reactions were scored for 7 daysaccording to Draize scoring system. The results were also interpreted according to the E.E.C. Directive of 29 July 1983 83/467/EEC adapting Council Directive 67/548/EEC on the regulations relating to the classification, packaging and labelling of dangerous substances.

 

 

Well-defined erythema was observed within 3 days of exposure in all animals. Signs of keratinization were observed on day 7. Moderate edema was observed at 24 hours in all animals, and regressed to slight by day 3. No corrosive effects were observed.

 

 

Since the Primary irritation index of 4.7was obtained ,the chemical Dicyclopentadiene was considered to bemoderately irritatingto the skin ofNew Zealand Whiterabbits .