Registration Dossier

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
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
cyclooctene of Hüls AG; purity: 92.7 %

Test animals

Species:
rabbit
Strain:
other: Small white russian
Details on test animals or test system and environmental conditions:
TEST ANIMALS: 
- Strain: Small white Russian, Chbb-SPF
- Sex: male and female
- Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Weight at study initiation: 2.2 - 2.7 kg
- Number of animals: 3 males, 3 females
- Water: ad libitum
- Diet: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 °C +/- 1 °C
- Humidity (%): 60 % +/- 5%
- Air changes (per hr): 15 times/hour
- Photoperiod (hrs dark / hrs light): 12-hour light/dark rythm

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: 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 20 days  after patch removal
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: 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:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 1, 24, 48, 72 hours
Score:
1.17
Max. score:
8
Reversibility:
fully reversible within: 20 days
Remarks on result:
other: induration of skin (day 6) followed by formation of  eschar, which detached completely between days 10 and 20
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
1.11
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0

Any other information on results incl. tables

AVERAGE SCORE
- Erythema: 1.11
- Edema: 0
- irritation index: 1.17/8
REVERSIBILITY: complete within 20 days
OTHER EFFECTS: induration of skin (day 6) followed by formation of  eschar, which detached completely between days 10 and 20.

Applicant's summary and conclusion

Conclusions:
In an acute dermal irritation study 0.5 mL cyclooctene were applied to the shaved skin of a group of three male and three female rabbits for 4 hours. Based on the results the substance is classified as not irritating to the skin according to present European legislation.
Executive summary:

In an acute dermal irritation study 0.5 mL cyclooctene were applied to the shaved skin of a group of three male and three female rabbits for 4 hours. No oedema were observed. Very slight to well defined erythema was noted and the average score (24 -72h) was 1.11. In five animals induration and eschar formation was noted. Eschar began to detach from day 10 and all animals were free of signs of toxicity at 20 days after application.