Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: 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other: GLP compliant, near guideline study, available as unpublished report, minor restrictions in design or reporting but otherwise adequate for assessment.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:
no guideline followed
Principles of method if other than guideline:
Skin irritation assessed, using Draize scale, after 24 hour dermal exposure to 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-indene on abraded skin.
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): 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
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

Test system

Type of coverage:
semiocclusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2g/kg
- Concentration (if solution): administered as supplied
Duration of treatment / exposure:
24 h
Observation period:
14 days
Number of animals:
10 (5/sex)
Details on study design:
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


SCORING SYSTEM: Erythema and oedema assessed using scoring system of Draize et al. 1944

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
10 rabbits
Time point:
other: 24.5 h
Score:
3.7
Max. score:
4
Reversibility:
no data
Remarks on result:
other: 24 h exposure to abraded skin
Irritation parameter:
edema score
Basis:
mean
Remarks:
10 rabbits
Time point:
other: 24.5 h
Score:
3.5
Max. score:
4
Reversibility:
no data
Remarks on result:
other: 24 h exposure to abraded skin

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

Mean score

3.7

3.5

 

Applicant's summary and conclusion

Conclusions:
DHDCPD was irritant to the abraded skin of rabbits following a 24 hour dermal application.
Executive summary:

Groups of 5 male and 5 female New Zealand white rabbits rats were dosed with 2000 mg/kg of dihydro dicycolpentadiene (DHDCPD) 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. Redness of the back was seen clinically in 4 males and 5 females and the skin sites were assessed for erythema and oedema, using the Draize scoring system, at the end of the exposure period. The mean scores were 3.7 for erythema and 3.5 for oedema for the 10 rabbits. DHDCPD was irritant to the abraded skin of rabbits following a 24 hour dermal application.