Registration Dossier
Registration Dossier
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EC number: 224-778-8 | CAS number: 4488-57-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- 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- other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment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:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- other: Modified Buehler test
Test material
- Reference substance name:
- 3a,4,7,7a-tetrahydro-4,7-methanoindene
- EC Number:
- 201-052-9
- EC Name:
- 3a,4,7,7a-tetrahydro-4,7-methanoindene
- Cas Number:
- 77-73-6
- Molecular formula:
- C10H12
- IUPAC Name:
- 3a,4,7,7a-tetrahydro-1H-4,7-methanoindene
- Reference substance name:
- dicyclopentadiene
- IUPAC Name:
- dicyclopentadiene
- 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)
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: David Hall Ltd., Burton-on-Trent, Staffordshire, UK
- Age at study initiation: 7-10 weeks
- Weight at study initiation: 320-395 g
- Housing: In groups of up to 4, in solid-floor polypropylene cages with softwood shavings
- Diet: Guinea Pig FD1 Diet ad libitum, Special Diet Services Ltd., Witham, Essex, UK
- Water: Mains water ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 18-21°C
- Humidity: 60-68%
- Air changes (per hr): Approximately 15/hour
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: 13 September 1988 To: 19 October 1988
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Undiluted for both induction and challenge.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Undiluted for both induction and challenge.
- No. of animals per dose:
- 12
- Details on study design:
- RANGE FINDING TESTS: Yes
- Groups of at least 2 animals were used and up to four different concentrations of the test substance were tested on each animal.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 9
- Exposure period: 6 hours
- Test groups: yes
- Control group: yes
- Site: an area on the shoulder
- Frequency of applications: on days 0, 2, 4, 7, 9, 11, 14 16 and 18
- Concentrations: 0.5 mL of undiluted test material
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 10
- Exposure period: 6 hours
- Test groups: yes
- Control group: yes
- Site: an area of flank
- Concentrations: 0.2 mL of undiluted test material
- Evaluation (hr after challenge): Approximately 24 and 48 hours after patch removal
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- undiluted test material
- No. with + reactions:
- 0
- Total no. in group:
- 12
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: undiluted test material. No with. + reactions: 0.0. Total no. in groups: 12.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- undiluted test material
- No. with + reactions:
- 0
- Total no. in group:
- 12
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: undiluted test material. No with. + reactions: 0.0. Total no. in groups: 12.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- blank patch
- No. with + reactions:
- 0
- Total no. in group:
- 12
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: blank patch. No with. + reactions: 0.0. Total no. in groups: 12.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- blank patch
- No. with + reactions:
- 0
- Total no. in group:
- 12
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: blank patch. No with. + reactions: 0.0. Total no. in groups: 12.0.
Any other information on results incl. tables
Scattered mild redness was commonly seen at the induction sites during the induction phase. Other adverse skin reactions were fissuring, dry, thickened, straw-coloured skin (possible hyperkeratinisation), loss of skin suppleness, superficial cracking of the skin and small superficial scattered scabs. These reactions sometimes precluded evaluation of erythema.
No signs of skin irritation were noted in control animals during induction.
No skin responses were noted in test or control animals at 24 or 48 hours after challenge.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- In a modified (9 induction) Beuhler test in female guinea pigs , there were no skin responses following challenge with undiluted dicyclopentadiene 75%w. Dicyclopentadiene 75% is therefore considered to be non-sensitising to guinea pig skin.
- Executive summary:
The sensitization potential of dicyclopentadiene 75% was investigated in female guinea pigs in a modified (9 -induction) Buehler test. The animals were dermally exposed to 0.5 mL undiluted dicyclopentadiene 75% for each of 9 induction phases. Scattered mild redness was commonly seen at the induction sites during the induction phase. Other adverse skin reactions were fissuring, dry, thickened, straw-coloured skin (possible hyperkeratinisation), loss of skin suppleness, superficial cracking of the skin and small superficial scattered scabs. These reactions sometimes precluded evaluation of erythema. Following challenge with 0.2 mL undiluted dicyclopentadiene 75%, no skin responses were noted in test or control animals at 24 or 48 hours after challenge. It is concluded that dicyclopentadiene 75% was a non-sensitiser to guinea pig skin.
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