Registration Dossier
Registration Dossier
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EC number: 203-892-1 | CAS number: 111-65-9
Skin sensitisation
Administrative data
- 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.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- 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 source
- 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:
This data is being read across from the source study that tested Hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics based on analogue read across.
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.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
Test guideline
- 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
Test material
- Reference substance name:
- Hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics
- EC Number:
- 920-750-0
- Molecular formula:
- None available - not a single isomer - see remarks
- IUPAC Name:
- Hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics
- Details on test material:
- - Name of test material (as cited in study report): SBP 100/140
- Analytical purity:100% pure commercial product
- Composition of test material, percentage of components: SBP 100/140 consists of 35% C7, 50% C8, 15% C9 saturated hydrocarbon isomers. 65% n and isoparaffins, and 35% naphthenes.
- Other: Density = 0.73 g/cubic centimetre
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: p-strain
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- 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
Challengeopen allclose all
- 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
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- 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
Applicant's summary and conclusion
- 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.
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