Registration Dossier
Registration Dossier
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EC number: 203-892-1 | CAS number: 111-65-9
Endpoint summary
Administrative data
Description of key information
Skin sensitisation
Based on available read across data (Magnusson and Kligman Guinea-Pig Maximization tests (OECD TG 406)), Octane is not considered to be a skin sensitizer.
Respiratory sensitisation
No data available
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Scientifically valid guinea pig maximisation test
- Species:
- guinea pig
- Strain:
- other: p-strain
- Sex:
- male/female
- Route:
- intradermal and epicutaneous
- Vehicle:
- corn oil
- Concentration / amount:
- 1 % w/v in corn oil for intradermal induction
50 % for topical induction
25 % for topical challenge - Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 1 % w/v in corn oil for intradermal induction
50 % for topical induction
25 % for topical challenge - No. of animals per dose:
- 20 (10 males, 10 females), controls: 10 (5 males, 5 females)
- Positive control substance(s):
- no
- Key result
- Group:
- negative control
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 0
- Group:
- test chemical
- Dose level:
- 25 % w/v in corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no skin sensitization
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 0.0. Group: test group. Dose level: 25 % w/v in corn oil. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no skin sensitization.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 % w/v in corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no skin sensitization
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 % w/v in corn oil. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no skin sensitization.
- Key result
- Reading:
- other: 3rd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 % w/v in corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no skin sensitization
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 % w/v in corn oil. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no skin sensitization.
- Key result
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- other: Not sensitising
- Conclusions:
- The purpose of this study was to determine the skin sensitization potential of the test substance, hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics. Ten male and ten female guinea pigs were used as a test group, and five male and five female guinea pigs were used as a control group. The test group underwent an intradermal induction of 1.0 %w/v test material in corn oil. Then a topical induction of 50% w/v test substance in corn oil. The challenge was done with 25% w/v test material in corn oil. No skin reactions were noted during the challenge. The test substance is not sensitizing.
- Executive summary:
The purpose of this study was to determine the skin sensitization potential of the test substance, hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics. Ten male and ten female guinea pigs were used as a test group, and five male and five female guinea pigs were used as a control group. The test group underwent an intradermal induction of 1.0 %w/v test material in corn oil. Then a topical induction of 50% w/v test substance in corn oil. The challenge was done with 25% w/v test material in corn oil. No skin reactions were noted during the challenge. The test substance is not sensitizing.
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
There is no skin sensitisation data available for Octane. However, data is available for structural analogue Hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics. This data is read across to based on analogue read across and a discussion and report on the read across strategy is provided as an attachment in IUCLID Section 13.
Hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics
The purpose of this study (Shell, 1977) was to determine the skin sensitization potential of the test substance, Hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics. Ten male and ten female guinea pigs were used as a test group, and five male and five female guinea pigs were used as a control group. The test group underwent an intradermal induction of 1.0 %w/v test material in corn oil. Then a topical induction of 50% w/v test substance in corn oil. The challenge was done with 25% w/v test material in corn oil. No skin reactions were noted during the challenge. The test substance is not sensitizing.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
There are no reports of respiratory sensitisation from Octane in laboratory animals or from structural analogues in humans. However, the read across skin sensitisation study found no indication of skin sensitisation in guinea pigs. With these observations, it is presumed that Octane will not be a respiratory sensitising agent.
Justification for classification or non-classification
Based on available read across data, Octane does not meet the criteria for classification as a skin or respiratory sensitizer under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).
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