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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other: GLP compliant, near guideline study, available as unpublished report, minor restrictions in design or reporting but otherwise adequate for assessment.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Abraded skin
GLP compliance:
yes
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): DHDCPD
- Physical state: Liquid
- Density: 1.04 g/ml
- Analytical purity: Not reported
- Stability under test conditions: Not reported
- Storage condition of test material: Not reported

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: A USDA approved supplier (further details not reported)
- Weight at study initiation: 2.65-3.2 kg (males), 2.42-3.3 kg (females).
- Housing: Individually in stainless steel or galvanised cages.
- Diet : Charles River Rabbit chow (ad libitum)
- Water : Tap water (ad libitum)
- Acclimation period: 2 weeks

ENVIRONMENTAL CONDITIONS - not reported

IN-LIFE DATES: From: 16th January 1980 To: 30th January 1980

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area clipped 24 hours prior to dosing. Just prior to dosing the skin was abraded longitudinally every 2-3 cm over the dosing area, deep enough to penetrate the stratum corneum but not so deep as to disturb the derma or produce bleeding.
- Area of exposure: 4" x 12"
- % coverage: 10%
- Type of wrap if used: gauze

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Area thoroughly wiped
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Administered as received (denity 1.04 g/ml).
- Constant volume or concentration used: yes

Duration of exposure:
24 h
Doses:
2000 mg/kg
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: 3 times per day on day of dosing and twice daily thereafter for 14 days.
- Frequency of weighing: Pre-fast, post-fast, day 7 and day 14.
Animals which did not survive were weighed at the time of death or at the time when they were found dead.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: 1 male died on day 12.
Mortality:
1 male rabbit (no. 5) died on day 12 of the 14-day observation period.
Clinical signs:
Decreased activity and ataxia were seen in all animals after dosing. Redness of the back was seen in 4 males and 5 females. Diarrhoea and/or soft stools was seen in some animals. 1 male had a bloody nose caused by thrashing in the cage after wrapping.
Body weight:
Male 5 lost weight by day 7 and died on day 12. Two other males lost weight or did not gain weight between days 7 and 14.
All females either lost weight or gained very little weight during the 14 day observation period.
Gross pathology:
The following findings were were seen in several animals : pale and/or granular spleen; pale kidneys.
The following findings were were seen in individual animals: mottled or pale lungs; granular or mottled/pale liver.

Any other information on results incl. tables

Skin Irritation scores at 24.5 hours after application (Draize et al 1944).

Score

Erythema

Oedema

3 (moderate to severe)

3 males

4 males and 1 female

4 (Severe)

2 males and 5 females

1 male and 4 females

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal LD50 of dihydro dicyclopentadiene was greater than 2000 mg/kg to male and female rabbits, following application to abraded skin.
Executive summary:

Groups of 5 male and 5 female New Zealand white rabbits rats were dosed with 2000 mg/kg of dihydrodicycolpentadiene as a 24- hour dermal application to abraded skin (under a semi-occlusive dressing) and were observed daily for 14 days after dosing. One male died on day 12 of the observation period. Decreased activity and ataxia was seen in all animals after dosing and redness of the back was seen in 4 males and 5 females. Diarrhoea and/or soft stools were seen in some animals. Weight loss or reduced weight gain was seen in 3/5 males and all females over the 14-day observation period. Gross necropsy findings, seen in several animals, included pale and/or granular spleen and/or pale kidneys. The LD50 was greater than 2000 mg/kg to rabbits following dermal application to abraded skin.