Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
Reference:
Composition 1
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Test material information:
Composition 1
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;
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
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)

no further remarks

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1983-04-19 to 1983-04-25
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study
Reference:
Composition 1
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Test material information:
Composition 1
Species:
rabbit
Strain:
other:
Details on test animals or tissues 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: 2.1 - 2.9 kg
- Number of animals: 3 males, 3 females
- Controls: untreated eye
- 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;
Vehicle:
unchanged (no vehicle)
Controls:
other: identical animals, left eyes remained untreated
Amount / concentration applied:
undiluted
Amount applied: 0.1 ml
Duration of treatment / exposure:
not rinsed, not removed
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6
Details on study design:
Comment: not rinsed
EXAMINATIONS
- Ophtalmoscopic examination: 1, 24, 48, and 72 hours after treatment
- Scoring system: Draize (1959); evaluation: VCI notes on safety data  sheet
- Tool used to assess score: sodium fluorescein / ophthalmic lamp /  visual inspections
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1, 24, 48, 72 h
Score:
3.71
Max. score:
110
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.04
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.06
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.61
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.28
Max. score:
4
Irritant / corrosive response data:
AVERAGE SCORE
- Cornea: 0.04
- Iris: 0.06
- Conjunctivae: 0.61
- chemosis: 0.28
- Overall irritation score: 3.71/110
Other effects:
REVERSIBILITY: almost complete within 72 hours (1 score for redness in 1  animal left)

no further results

Conclusions:
According to the study, the test item showed no irritant effect on the eyes and mucosa of male and female rabbits.
Executive summary:

The test item was investigated for irritant effects on the eye and associated mucous membranes of 3 female and 3 male rabbits according to OECD TG 405 (1981). The test substance was applied in a single dose of 0.1 ml into the conjuntival sac of each animal. According to the study, the test item showed no irritant effect on the eyes and mucosa of male and female rabbits.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification