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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
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other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment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 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
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
- 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:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Interfauna (UK) Ltd., Wyton, Huntingdon, Cambridgeshire, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: males 231-256 g; females 210-255 g
- Fasting period before study: None
- Housing: Solid floor polypropylene cages with sawdust bedding
- Diet: Rat and Mouse expanded Diet No. 1 (Special Diet Services Ltd., Witham, Essex, UK) ad libitum
- Water: Mains drinking water ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20-21°C
- Humidity: 45-68%
- Air changes: approximately 15 per hour
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: 22 September 1988 To: 6 October 1988

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: shorn skin on back and flanks
- % coverage: 10%
- Type of wrap if used: aluminium foil occluded with double layers of adhesive strapping wound around trunk of animal

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with moist cotton wool
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.06 mL/kg bodyweight
- Constant volume or concentration used: yes
Duration of exposure:
24 hours
Doses:
2000 mg/kg bodyweight
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observed 1 and 4 hours after dosing and daily thereafter for 14 days. Bodyweights recorded on day of treatment and on days 7 and 14
- Necropsy of survivors performed: no
Statistics:
None, acute LD50 estimated.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
None
Clinical signs:
Vocalisation, lasting up to 30 minutes, noted in all animals after dosing. Hunched posture, lethargy, piloerection, erythema and oedema present in all animals on day 1. Isolated incidences of red/brown staining of snout and ptosis seen. All animals showed signs of eschar by day 3 which persisted until days 10 or 12. All treatment sites appeared normal by end of study.
Body weight:
All animals showed expected bodyweight gain.
Gross pathology:
No abnormalities were seen.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal LD50 of dicyclopentadiene 75% to the rat was greater than 2000 mg/kg body weight.
Executive summary:

The acute dermal toxicity of dicyclopentadiene 75% was assessed in a group of 5 male and 5 female rats. 2.06 mL/kg body weight was applied to the shorn flank and held in place with an occlusive dressing. Animals were observed at 1 and 4 hours after dosing and then daily for 14 days. Clinical signs present on day 1 included vocalisation lasting up to 30 minutes (noted in all animals after dosing), hunched posture, lethargy, piloerection, erythema and oedema, . Isolated incidences of red/brown staining of snout and ptosis were seen. All animals showed signs of eschar by day 3 which persisted until days 10 or 12. All treatment sites appeared normal by the end of study. All animals gained weight and there were no gross abnormalities at necropsy. The acute dermal LD50 of dicyclopentadiene 75% in the rat was greater than 2000 mg/kg body weight.