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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989-08-22 to 1989-12-15
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Decahydronaphthalene
EC Number:
202-046-9
EC Name:
Decahydronaphthalene
Cas Number:
91-17-8
Molecular formula:
C10H18
IUPAC Name:
decahydronaphthalene
Details on test material:
decahydronaphthalene of Hüls AG, purity 99 %

Test animals

Species:
rabbit
Strain:
other: Small white Russian, Chbb-SPF
Details on test animals or test system and environmental conditions:
TEST ANIMALS: 
- Strain: Small white Russian, Chbb-SPF
- Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Sex: male
- Weight at study initiation: 2.2 - 2.5 kg
- Housing: individually in steinless steel cages
- Food (ad libitum): K4 Alleindiät für Kaninchen, Ssniff Spezialfutter GmbH, 4770 Soest
- Water (ad libitum): tap water
- preparation of testing site 24 h before treatment (shaving, 10 x 10 cm)

ENVIRONMENTAL CONDITIONS:
- Temperature: 20 °C +/- 1 °C
- Humidity: 60 % +/- 5%
- Air changes: 15/ h
- Photoperiod: 12 h dark/ 12 h light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
undiluted
Duration of treatment / exposure:
4 hour(s)
Observation period:
 1, 24, 48, 72 hours, 6, 8, 10, and 14 days  after patch removal
Number of animals:
3
Details on study design:
ADMINISTRATION/EXPOSURE 
- Area of exposure: 6 cm²
- Total volume applied: 0.5 ml
- Occlusion: mull patch, elastic dressing
- Removal of test substance: washing with warm water
- Additional tests with 1 animal each: 3 minutes open application, 1 hour  semiocclusive application
- Post exposure period: 14 days
EXAMINATIONS
- Examination time points: 1, 24, 48, 72 hours, 6, 8, 10, and 14 days  after patch removal; evaluation based on readings 1-4
- Scoring system: OECD Guideline; evaluation: VCI notes on safety data  sheet and Appendix VI of 79/831/EEC

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Score:
7.5
Max. score:
8
Reversibility:
not reversible
Remarks on result:
other: Eschar formation
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
3.33
Max. score:
4
Reversibility:
not reversible
Irritant / corrosive response data:
AVERAGE SCORE
- Erythema: 4.00
- Edema: 3.33
REVERSIBILITY: Not reversible. Eschar detached and new skin within 14  days.
OTHER EFFECTS: After a 3-min open application or a 1-hour semiocclusive  application no necrosis was observed.

Applicant's summary and conclusion

Conclusions:
In this primary dermal irritation study, the test item was corrosive to the rabbit skin.
Executive summary:

In a primary dermal irritation study 3 Small White Russian, Chbb-SPF rabbits were dermally exposed to 0.5 ml of undiluted test item for 4 hours to the shaved back skin.  Animals then were observed for 14 days.  The formation of necroses was noted, the irritation index was 7.5/8. No necrosis was noted upon exposure duration of 3 min or 1 h. In this study, the test item was corrosive to the rabbit skin.