Registration Dossier
Registration Dossier
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EC number: 271-036-4 | CAS number: 68514-35-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1977-12-01
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable with restriction because although it is an acceptable and well documented study report a GLP statement was not provided and details regarding the test material and animal husbandry was not provided.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Magnusson and Kligman
- Principles of method if other than guideline:
- A range finding test used groups of two male and two female guinea-pigs to determine the concentrations of test material to be used for intradermal induction, topical induction and topical challenge.
Induction was accomplished via two rows of three intradermal injections. Topical application occurred one week after intradermal injections to the same area as the induction phase.
The challenge procedure was carried out two weeks after topical induction. - GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Alkenes, C11-15
- IUPAC Name:
- Alkenes, C11-15
- Details on test material:
- - Name of test material (as cited in study report): Internal Olefin 114 LP11
- Test substance: Alkenes, C11-15
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Shell Toxicology Laboratory (Tunstall), Breeding Unit
- Age at study initiation: Not reported
- Weight at study initiation: Not reported
- Housing: Not reported
- Diet (e.g. ad libitum): Not reported
- Water (e.g. ad libitum): Not reported
- Acclimation period: Not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- corn oil
- Concentration / amount:
- Following the range finding test the following concentrations were used:
Intradermal induction: 0.05% w/v in corn oil
Topical induction: 15% w/v in corn oil
Topical Challenge: 10% w/v in corn oil
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- Following the range finding test the following concentrations were used:
Intradermal induction: 0.05% w/v in corn oil
Topical induction: 15% w/v in corn oil
Topical Challenge: 10% w/v in corn oil
- No. of animals per dose:
- Groups of ten male and ten females were used with an additional five males and five females used as controls.
- Details on study design:
- RANGE FINDING TESTS: Groups of two male and two females were used to determine the concentrations of test material to be used for induction (intradermal and topical) and challenge phases.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:
Intradermal injections: two rows of three intradermal injections:
Topical applications:
One week after the intradermal injections Whatman No. 3 mm filter paper was soaked in a solution of test material and placed over the injection sites and covered by overlapping plastic tape.
- Exposure period: Topical application = 48 hours.
- Test groups: ten male and ten females
- Control group: five males and five females
- Site: side of midline in the shorn skin of the shoulder region
- Frequency of applications: One topical application after one week of intradermal injections.
- Duration:
- Concentrations: Intradermal injections 0.5% corn oil (0.1 ml Freund's complete adjuvant, 0.1 ml test material in solvent, and 0.1 ml test material in 50:50 FCA/solvent)
Topical Induction: 15% w/v/ corn oil
B. CHALLENGE EXPOSURE
- No. of exposures: One topical induction exposure
- Day(s) of challenge: 2 days
- Exposure period: 24 hours
- Test groups: ten males and ten females.
- Control group: five males and five females
- Site: flank of test and control animals.
- Concentrations: 10% w/v corn oil
- Evaluation (hr after challenge): 24 and 48 hours after challenge.
OTHER: - Challenge controls:
- Five male and five females were used for challenge controls with application of 0.1 millitre FCA.
- Positive control substance(s):
- not specified
Study design: in vivo (LLNA)
- Concentration:
- 0.1 mililiters of 0.05% w/v corn oil
0.1 mililiters of 15% w/v corn oil
0.1 mililiters of 10% w/v corn oil - No. of animals per dose:
- Ten male and ten female
- Details on study design:
- None.
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- No data
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: topical challenge
- Hours after challenge:
- 0
- Group:
- negative control
- Dose level:
- 0.0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- not reported
- Remarks on result:
- other: Reading: other: topical challenge. . Hours after challenge: 0.0. Group: negative control. Dose level: 0.0%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: not reported.
- Reading:
- other: topical challenge
- Hours after challenge:
- 0
- Group:
- test chemical
- Dose level:
- 15%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- not reported
- Remarks on result:
- other: Reading: other: topical challenge. . Hours after challenge: 0.0. Group: test group. Dose level: 15%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: not reported.
- Reading:
- other: topical challenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- not reported
- Remarks on result:
- other: Reading: other: topical challenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.0%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: not reported.
- Reading:
- other: topical challenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 15%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- not reported
- Remarks on result:
- other: Reading: other: topical challenge. . Hours after challenge: 24.0. Group: test group. Dose level: 15%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: not reported.
- Reading:
- other: topical challenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- not reported
- Remarks on result:
- other: Reading: other: topical challenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: not reported.
- Reading:
- other: topical challenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 15%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- not reported
- Remarks on result:
- other: Reading: other: topical challenge. . Hours after challenge: 48.0. Group: test group. Dose level: 15%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: not reported.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Based on the responses the material is not considered to be a skin sensitizer in quinea-pigs.
- Executive summary:
In a dermal sensitization study using Internal Olefin 114 LP11 in corn oil, ten male and ten female guinea pigs were tested using the method of Magnusson and Kligman.
Using a scoring method of -ve, trace, +ve, and ++ve, erythema responses to the topical challenge dose was tabulated. Based on these results, Internal Olefin 114 LP11 is not a dermal sensitizer.
This study received a Klimisch score of 2 and is classified as reliable with restriction because although it is an acceptable and well documented study report a GLP statement was not provided and details regarding the test material and animal husbandry was not provided.
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