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EC number: 916-737-4 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1975
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Brief summary report. Only a very short description is reported. Method not according test standards, non GLP. High concentrations tested, sufficient number of dosing, irritation observed, so induction is possible.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
- Principles of method if other than guideline:
- Open epicutaneous test (OET).
- GLP compliance:
- no
- Remarks:
- not present at the time of performance.
- Type of study:
- open epicutaneous test
- Justification for non-LLNA method:
- Alternative in vivo test
Test material
- Reference substance name:
- Reaction mass of 2-[7-isopropyl-5-methylbicyclo[2.2.2]oct-5-en-2-yl]-1,3-dioxolane and 2-[8-isopropyl-6-methylbicyclo[2.2.2]oct-5-en-2-yl]-1,3-dioxolane
- EC Number:
- 916-737-4
- Molecular formula:
- Reaction mass of 2-[7-isopropyl-5-methylbicyclo[2.2.2]oct-5-en-2-yl]-1,3-dioxolane and 2-[8-isopropyl-6-methylbicyclo[2.2.2]oct-5-en-2-yl]-1,3-dioxolane
- IUPAC Name:
- Reaction mass of 2-[7-isopropyl-5-methylbicyclo[2.2.2]oct-5-en-2-yl]-1,3-dioxolane and 2-[8-isopropyl-6-methylbicyclo[2.2.2]oct-5-en-2-yl]-1,3-dioxolane
- Details on test material:
- - Name of test material (as cited in study report): Glycolierral
Please note that although the substance is stated as the mono-constituent substance 2-(7-Isopropyl-5-methylbicyclo[2.2.2]oct-5-en2yl)-1,3-dioxolane in the report, analytical data on the same batch shows that the test substance is in fact the multi-constituent substance Reaction mass of 2-(7-isopropyl-5(6)-methylbicyclo[2.2.2]oct-5-en-2-yl)-1,3-dioxolane and 2-(8-isopropyl-5(6)-methylbicyclo[2.2.2]oct-5-en-2-yl)-1,3-dioxolane.
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No data.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: ethanol
- Concentration / amount:
- Induction: 3, 10, 30 and 100%
Challenge: 3, 10, 30 and 100%
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: ethanol
- Concentration / amount:
- Induction: 3, 10, 30 and 100%
Challenge: 3, 10, 30 and 100%
- No. of animals per dose:
- 8
- Details on study design:
- RANGE FINDING TESTS:
The substance was applied undiluted as well as dissolved in ethanol at concentrations of 30, 10, 3, 1, 0.3, 0.1 and 0.03% in order to establish a dose response curve which would permit the determination of the minimal irritating and the maximal tolerated concentrations on an "all or none basis". The minimal irritant concentration was defined as the lowest one causing mild erythema in at least 25% of an animal group. The maximal non irritant concentration was defined as the highest one not causing macroscopic reactions in any of the animals of the group.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 21 consecutive days
- Test groups: four, 6-8 animals/group
- Control group: yes
- Site: cilpped flank
- Frequency of applications: daily
- Duration: daily for 21 consecutive days
- Concentrations: 3, 10, 30 and 100%
B. CHALLENGE EXPOSURE
- No. of exposures: single
- Day(s) of challenge: 21 and 35 (re-challenge)
- Test groups: four, 6-8 animals/group
- Control group: yes
- Site: contralateral flank
- Concentrations: 3, 10, 30 and 100%
- Evaluation (hr after challenge): 24, 48 and 72 hours - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 3, 10, 30 and 100%
- No. with + reactions:
- 0
- Total no. in group:
- 8
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 3, 10, 30 and 100%. No with. + reactions: 0.0. Total no. in groups: 8.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 3, 10, 30 and 100%
- No. with + reactions:
- 0
- Total no. in group:
- 8
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 3, 10, 30 and 100%. No with. + reactions: 0.0. Total no. in groups: 8.0.
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 3, 10, 30 and 100%
- No. with + reactions:
- 0
- Total no. in group:
- 8
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 72.0. Group: test group. Dose level: 3, 10, 30 and 100%. No with. + reactions: 0.0. Total no. in groups: 8.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 3, 10, 30 and 100%
- No. with + reactions:
- 0
- Total no. in group:
- 8
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 3, 10, 30 and 100%. No with. + reactions: 0.0. Total no. in groups: 8.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 3, 10, 30 and 100%
- No. with + reactions:
- 0
- Total no. in group:
- 8
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 3, 10, 30 and 100%. No with. + reactions: 0.0. Total no. in groups: 8.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 3, 10, 30 and 100%
- No. with + reactions:
- 0
- Total no. in group:
- 8
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 3, 10, 30 and 100%. No with. + reactions: 0.0. Total no. in groups: 8.0.
Any other information on results incl. tables
Pre-screen test, skin irritation after a single application: the lowest irritant concentration was 10% (very slight) and the highest non irritant concentration was 3%.
Main study:
Skin irritation after repeated applications over 21 consecutive days:
Concentration % |
7 days |
14 days |
21 days |
100 |
slight |
slight |
slight |
30 |
very slight |
slight |
slight |
10 |
very slight |
very slight |
very slight |
3 |
no irritation |
no irritation |
no irritation |
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In a sensitisation study, an open epicutaneous test, Glycolierral was found not to be a skin sensitiser.
- Executive summary:
A skin sensitisation study with Glycolierral was performed according to an open epicutaneous test method. 21 consecutive days 3, 10, 30 and 100% test material was given to 8 animals for each concentration. The highest non irritant concentration after a single and after repeated applications was 3%. Higher concentrations caused very slight to slight irritation only.
No reactions were observed at the day 21 and 35 challenge in any of the test control group animals at any of the tested concentrations.
Based on these results Glycolierral is not regarded as a skin sensitizer.
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