Registration Dossier
Registration Dossier
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EC number: 616-328-8 | CAS number: 76359-37-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Analogue substance tested.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
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:
- Analogue substance (refer to IUCLID chapter 13)
- IUPAC Name:
- Analogue substance (refer to IUCLID chapter 13)
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- Intradermal injections (0.1 ml/site) were made into the clipped flank of two guinea-pigs at a concentration of 5 % of the test article in physiological saline. The resulting dermal reactions were assessed 24 hours later.
Challengeopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- Intradermal injections (0.1 ml/site) were made into the clipped flank of two guinea-pigs at a concentration of 5 % of the test article in physiological saline. The resulting dermal reactions were assessed 24 hours later.
- No. of animals per dose:
- The animals were distributed as follows:
5 males, 5 females for the vehicle control group and 10 males, 10 females for the test article group.
Results and discussion
- Positive control results:
- According to the procedures used in the experiment, no differences between the test group and the vehicle-treated controls were evident after epidermal challenge application of the substance.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5 % in the vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no toxic symptoms
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5 % in the vehicle. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no toxic symptoms.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5 % in the vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no toxic symptoms
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5 % in the vehicle. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no toxic symptoms.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The skin sensitization study was conducted with the analogue substance. This substance is considered to possess no skin sensitizing (contact allergenic) potential in this test system. Due to the structural similarity of the analogue substance and the substance subject of registration, the substance subject of registration is expected to show a comparable behaviour.
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