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EC number: 213-243-4 | CAS number: 931-87-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991-02-25 to 1991-04-05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- (Z)-cyclooctene
- EC Number:
- 213-243-4
- EC Name:
- (Z)-cyclooctene
- Cas Number:
- 931-87-3
- Molecular formula:
- C8H14
- IUPAC Name:
- (Z)-cyclooctene
- Details on test material:
- cyclooctene of Hüls AG, Sample from B 803, ID No. 3630/81 288, produced December 1990.
Purity 96.2 % (GC-FID area).
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS:
- Strain: Dunkin-Hartley, Pirbright White, BOR:DHPW (SPF)
- Sex: female
- Source: Fa. Winkelmann, Borchen (Germany)
- Age: healthy young adults
- Weight at study initiation: 464 g (mean test); 460 g, 457 g (means control groups 1 and 2)
- Controls: 10 each for 1st and 2nd challenge; treatment: vehicle
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: corn oil (MEH 56)
- Concentration / amount:
- 1st challenge: 100 % (0.20 ml) with patch on left side (control group: 1)
2nd challenge: 10 % (0.12 ml) with patch on right side (control group: 2)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: corn oil (MEH 56)
- Concentration / amount:
- 1st challenge: 100 % (0.20 ml) with patch on left side (control group: 1)
2nd challenge: 10 % (0.12 ml) with patch on right side (control group: 2)
- No. of animals per dose:
- test: 20
control: 10 - Details on study design:
- 1st application: Induction 2.5 % intracutaneous
2nd application: Induction undiluted occlusive epicutaneous
3rd application: Challenge undiluted occlusive epicutaneous
ADMINISTRATION/EXPOSURE
- Preparation of test substance for induction: clear solution in vehicle
- Induction schedule:
day 0 injection,
day 6 induction of slight to moderate skin irritation (10 % sodium dodecyl sulfate in petrolatum)
days 7-9 patch treatment (0.25 ml, 48 hours), readings 1 and 24 hours after patch removal
- Injection details: 0.1 ml each at 6 positions on shoulders:
2 x Freund's Complete Adjuvant / deionized water (50:50)
2 x test substance 2.5 % in corn oil
2 x test substance 2.5 % in Freund's Complete Adjuvant / corn oil (50:50) simultaneous and symmetrical application of each solution
controls: corn oil instead of test substance
- Challenge schedule: 1st challenge on day 21, 2nd challenge on day 28 occlusive patch treatment for 24 hours,
readings 24, 48, 72 hours after administration
- Concentrations used for challenge:
1st challenge: 100 % (0.20 ml) with patch on left side (control group: 1)
2nd challenge: 10 % (0.12 ml) with patch on right side (control group: 2)
- Positive control: 1-chloro-2,4-dinitrobenzene
EXAMINATIONS
- Grading system: as usual for skin irritation, 0-8 scores possible
- Pilot study: dose finding (intracutaneous toxicity and skin irritation)
intracutaneous doses: 0.1 ml x 0; 0.25; 0.50; 1.0; 2.5; 5.0; 10.0 % w/w,
2 animals each dermal doses: 0.1 ml x 2.5; 25; 50; 100 % w/w
4 animals each with 4 different concentrations at different sites
24 hour occlusive patch test, readings 24 / 48 / 72 hours after administration - Positive control substance(s):
- yes
- Remarks:
- 1-chloro-2,4-dinitrobenzene
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- see below
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 %. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: see below.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- see below
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100 %. No with. + reactions: 8.0. Total no. in groups: 10.0. Clinical observations: see below.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Clinical observations:
- see below
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 100 %. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: see below.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- see below
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 100 %. No with. + reactions: 3.0. Total no. in groups: 10.0. Clinical observations: see below.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no.
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 72.0. Group: test group. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no.
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 72.0. Group: negative control. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no.
Any other information on results incl. tables
RESULTS OF PILOT STUDY:
2.5 % was chosen for intracutaneous induction
100 % test substance caused no dermal irritation
RESULTS OF TEST
- Sensitization reaction:
1st challenge: inconclusive results due to irritation in both test and control groups.
2nd challenge: 0/20 animals positive at 48 hours and at 72 hours after application = no sensitization, no animals positive in
control group
- Clinical signs: No signs of systemic toxicity were observed.
1st induction, FCA + water application sites: severe erythema, severe edema, and deep wounds within 24 hours.
1st induction, test substance + vehicle application sites: distinct erythema, very slight edema within 1 hour; very slight erythema
within 24 hours, edema were absent in 9/20 animals.
1st induction, vehicle application sites: distinct erythema, very slight edema within 1 hour; very slight erythema left in only 5/20
animals and no more edema within 24 hours.
1st induction, FCA + test substance application sites: distinct to severe erythema, severe edema and (in 8/20 animals) deep
wounds within 24 hours.
1st induction, FCA + vehicle application sites: severe erythema and edema and necrosis within 24 hours.
2nd induction, FCA + water application sites: severe erythema and edema wih deep wounds within 1 hour after patch removal;
eschar formation within 24 hours
2nd induction, test substance + vehicle application sites: eschar formation 1 and 24 hours after patch removal
2nd induction, vehicle application sites: eschar formation 1 and 24 hours after patch removal
2nd induction, FCA + test substance application sites: eschar formation 1 hour after patch removal, 1 animal with deep wounds
and severe edema; 24 hours after patch removal eschar in 14/20 animals, severe edema and crusts on heavy erythema with
deep wounds in 6/20 animals.
2nd induction, FCA + vehicle application sites: 1 hour after patch removal eschar in 14/20 animals, severe erythema and
edema with deep wounds in 6/20 animals. 24 hours after patch removal eschar formation at injection sites of 9/20 animals,
severe edema and incrustation on severe erythema / deep wounds in other 11 animals.
1st challenge, test group: 24 hours after patch removal very slight to distinct erythema and edema in all animals; 24 hours later
the edema had disappeared in 3/20 animals.
1st challenge, control group 1: 24 hours after patch removal very slight to distinct erythema and (in 8/10 animals) edema; 24 hours
later the edema were absent in 3/10 animals.
2nd challenge: no signs of irritation in test group and control group 2.
- Other: Body weight development was similar in test and control groups.
Applicant's summary and conclusion
- Conclusions:
- No skin sensitization was induced by the test material. In this study, cyclooctene is not a dermal sensitizer.
- Executive summary:
In a dermal sensitization study with cyclooctene in corn oil, was tested in a group of young Dunkin-Hartley guinea pigs using the method of Magnusson and Kligman. 1-Chloro-2,4-dinitrobenzene served as positive control material. No signs of systemic toxicity were noted.
No skin sensitization was induced by the test material. In this study, cyclooctene is not a dermal sensitizer.
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