Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1983-04-19 to 1983-05-09
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
1,5-Cyclooctadiene of Hüls AG; Purity 99.5 %

Test animals

Species:
rabbit
Strain:
other: Small white Russian, Chbb-SPF
Details on test animals and environmental conditions:
TEST ANIMALS: 
- Strain: Small white Russian, Chbb-SPF
- Sex: male and female
- Source: F. Winkelmann, Borchen (Germany)
- Weight at study initiation: 2.3 - 2.7 kg
- Number of animals: 3 males, 3 females
- Feed: K4 complete feed for rabbits (Ssniff, Soest, Germany);
- Water: tap water ad libitum
Environmental conditions:
- Room temperature: 20°C (+/- 1°C);
- Humidity: 60% (+/- 5%);
- Air change: 15 times/hour;
- Light: 12 hour light/dark rhythm;

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: no vehicle
Controls:
not required
Amount / concentration applied:
undiluted
Duration of treatment / exposure:
4 hour(s)
Observation period:
20 days
Number of animals:
6
Details on study design:
ADMINISTRATION/EXPOSURE 
- Area of exposure: 6 cm2
- Total volume applied: 0.5 ml
- Occlusion: mull patch, polyethylene film, elastic dressing
- Removal of test substance: careful washing with deionized water
- Post exposure period: 20 days
EXAMINATIONS
- Scoring system: OECD; evaluation: VCI notes on safety data sheet
- Examination time points: 1, 24, 48, 72 hours, 6, 8, 10 and 20 days  
after patch removal; evaluation based on readings 1-4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1, 24, 48, 72 h
Score:
1
Max. score:
8
Reversibility:
fully reversible within: 20 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
1.06
Max. score:
4
Reversibility:
fully reversible within: 20 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
AVERAGE SCORE
- Overall irritation index: 1.0
- Erythema: 1.06
- Edema: 0
REVERSIBILITY: complete within 20 days.
Other effects:
OTHER EFFECTS: eschar formation (days 6-10)

Any other information on results incl. tables

no further remarks

Applicant's summary and conclusion

Conclusions:
According to this study, the test item showed slightly irritant effect on the skin of male and female rabbits.
Executive summary:

To test the acute skin irritant effect the test item was applied to the shaven dorsal skin of 3 female and 3 male rabbits. The product was administered undiluted and the time of exposure in the patch test was 4 hours. The dermal reactions were fully reversible within 20 days. According to the study, the test item 1,5-Cyclooctadiene showed slightly irritant effect on the skin of male and female rabbits.