Registration Dossier
Registration Dossier
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EC number: 274-407-9 | CAS number: 70210-10-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- from August 8 to September 10, 1999
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 1996
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Guinea pig maximisation test was available.
Test material
- Reference substance name:
- Similar Substance 01
- IUPAC Name:
- Similar Substance 01
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright-White
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann, D-33178 Borchen, SPF breeding colony.
- Weight at study initiation: 354 g.
- Housing: fully air-conditioned rooms in macrolon cages (type 4) on soft wood granulate in groups of 5 animals.
- Diet: ad libitum.
- Water: ad libitum.
- Acclimation period: at least 7 days.
ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C.
- Humidity: 50 ± 20 %.
- Photoperiod: 12 hours light, 12 hours darkness.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: sesame oil; 50 % Freund's Complete Adjuvant emulsion
- Concentration / amount:
- 1 %
- Day(s)/duration:
- day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: sesame oil
- Concentration / amount:
- 25 %
- Day(s)/duration:
- day 8 (48 h)
- Adequacy of induction:
- other: highest non-irritant concentration
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: sesame oil
- Concentration / amount:
- 25 %
- Day(s)/duration:
- day 22 (24 h)
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Determination of the primary non-irritant concentration: 3.
Determination of the tolerance of the intradermal injections: 2.
Control group: 5.
Treatment group: 10. - Details on study design:
- RANGE FINDING TESTS:
- determination of primary non-irritant concentration: test substance at 1 %, 5 % and 25 % in sesame oil applied by occlusive bandage for 24 h. Examination for erythema and oedema, 24 h after removal of patch.
- determination of tolerance of intradermal injections: test substance at 0.2 %, 1 % and 5 % in sesame oil; examination of injection sites for local tolerance 24, 48, 72, 96 h after administration.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: intradermal injections (day 1) + dermal application (day 8).
- Exposure period: day 1 - 21.
- Test groups: 10 animals.
- Control group: 5 animals.
- Site: dorsal area.
- Duration: dermal induction 48 h.
- Concentrations: 1 % for intradermal induction , 25 % for dermal induction.
B. CHALLENGE EXPOSURE
- Day of challenge: day 22.
- Exposure period: 24 h.
- Test groups: 10 animals.
- Control group: 5 animals.
- Site: left flank.
- Concentrations: 25 %.
- Evaluation (hr after challenge): 24 and 48 h after removal of patch. - Positive control substance(s):
- yes
- Remarks:
- alpha-hexyl cinnamic andehyde
Results and discussion
- Positive control results:
- After challenge, 80 % of animals of the treatment group showed a positive skin reaction during the observation period.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
Any other information on results incl. tables
Preliminary tests
No signs of irritation occurred after application of different test concentrations (1, 5, 25 %). Based on these results, a concentration of 25 % was chosen for dermal application.
Intradermal injection with 5 % preparation was not possible due to high viscosity. Intradermal injections with 1 % preparation caused well-defined or slight erythema and oedema. Slight erythema was noted in 0.2 % preparation one day after injection. A 1 % preparation was selected for intradermal injections in main test.
Main study
Treated animals showed no impaired body weight gains and no clinical signs of intoxication throughout the study.
Intradermal induction treatment
Intradermal injections with Freund's Adjuvant (with and without test substance) caused severe erythema and oedema as well as indurations and encrustations. Administration sites treated with test substance in sesame oil showed well-defined or slight erythema and oedema. Intradermal injections of the vehicle alone exhibited no signs of irritation.
Dermal induction treatment
After removal of patches, severe erythema and oedema, indurated and encrusted skin as well as necrosis were observed at sites previously treated with Freund's adjuvant. Administration sites threated with test substance showed slight erythema. Administration sites tretaed with vehicle alone showed no signs of irritation.
Dermal challenge treatment
No skin reactions were observed in control and treatment group 24 and 48 hours after removal of occlusive bandage.
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitising according to the CLP Regulation (EC 1272/2008).
- Conclusions:
- After challenge, no animal of treatment group showed a positive skin reaction during the observation period. Thus, the percentage was below the threshold of 30 % for classification according to the CLP Regulation (EC 1272/2008).
- Executive summary:
Method
Guinea pig maximisation test.
Preliminary study to determine primary non-irritant concentration (3 animals) and tolerance of intradermal injections (2 animals), by exposure to test substance in sesame oil.
Main study (10 animals in treatment group + 5 animals in control group), on female guinea pigs. In the main study: on day 1, intradermal induction at 1 % w/w dose in sesame oil or in 50 % Freund's adjuvant; on day 8, dermal induction at 25 % w/w dose in sesame oil by occlusive application for 48 hours; on day 22, dermal challenge at 25 % dose in sesame oil by occlusive application for 24 hours. Examinations 24 and 48 hours after patches removal.
Result
No signs of irritation occurred after application of different test concentrations (1, 5, 25 %). Based on these results, a concentration of 25 % was chosen for dermal application.
Intradermal injection with 5 % preparation was not possible due to high viscosity. Intradermal injections with 1 % preparation caused well-defined or slight erythema and oedema. Slight erythema was noted in 0.2 % preparation one day after injection. Based on this test, a 1 % preparation was selected for intradermal injection in main test.
In the main study no clinical signs of intoxication nor impairment of body weight gain were noted.
In dermal challenge treatment, no skin reactions were noted in control and treatment groups 24 and 48 h after removal of occlusive bandage.
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