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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation, other
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment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:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): DCPD 75%
- Physical state: clear, yellow coloured liquid
- Analytical purity: not reported
- Composition of test material, percentage of components: endo dicyclopentadiene: 71.1, exo dicyclopentadiene: 0.8, m-bicyclozonadiene: 1.4, CPD-MCPD codimers: 15.2, tricyclopentadiene: 0.3, CPD-butadiene codimer: 1.3, CPD-piperylene codimer: 0.3, CPD-isoprene codimer: 0.3, benzene: <0.1, misc.hydrocarbons: balance.
- Lot/batch No.: PD Sample 1
- Stability: Not determined
- Specific gravity (15/15°C) 0.9811
- Other: Gardner colour: 4+; total sulfur: 60 ppm (w/w); flashpoint 39°C pct (w/w)

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.45-2.67 kg
- 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: 15-20°C
- Humidity: 40-66%
- Air changes (per hr): Approximately 15/hour
- Photoperiod: 12 hrs dark / 12 hrs light):

IN-LIFE DATES: From: 14 November 1988 To: 22 November 1988

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
Single application
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- The eyes were not washed

SCORING SYSTEM:
- According to the numerical system of Draize JH, 1959 and a modified version of the Kay and Calandra system, 1962

TOOL USED TO ASSESS SCORE:
- Standard ophthalmoscope

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-72 hour
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 -72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24-72 hours
Score:
0.43
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: slight redness present in 1 animal at 72 h.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 -72 hours
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: slight chemosis in 1 rabbit at 24 h

Any other information on results incl. tables

Dicyclopentadiene 75%: Eye irritation scores according to the Draize scheme

Time

Cornea

Iris

Conjunctiva

 

 

 

Redness

Chemosis

Animal number

545

544

547

545

544

547

545

544

547

545

544

547

after 1 hour

0

d

d

1

1

1

3

2

2

2

2

2

after 24 hours

0

0

0

0

0

0

1

1

0

0

1

0

after 48 hours

0

0

0

0

0

0

0

1

0

0

0

0

after 72 hours

0

0

0

0

0

0

0

1

0

0

0

0

mean scores 24-72h

0

0

0

0

0

0

0.3

1

0

0

0.3

0

d = dulling of corneal surface

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Dicyclopentadiene 75% was a moderate irritant to the rabbit eye at 1 hour but was practically non-irritating at 24, 48 and 72 hours.
Executive summary:

Eye irritation was assessed in 3 New Zealand white rabbits. 0.1 mL dicyclopentadiene 75% was instilled into the conjunctival sac and the eyes were scored for irritation responses at 1, 24, 48 and 72 hours and at 7 days after instillation. At 1 hour, corneal dulling was present in 2 eyes, iridial inflammation and moderate conjunctival irritation were present in all 3 eyes, giving an overall mean score of 18.5 at 1 hour, which corresponds to moderate irritation (Kay and Callandra, 1962). Signs of irritation regressed to minimal in 2 eyes at 24 hours but persisted in 1 animal at 48 and 72 hours. All effects were fully reversible within 7 days. Dicyclopentadiene 75% was a moderate irritant to the rabbit eye at 1 hour but was practically non-irritating at 24, 48 and 72 hours. According to EEC and GHS labelling regulations dicyclopentadiene is a non-irritant and requires no symbol or risk phrase.