Registration Dossier
Registration Dossier
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EC number: 922-963-4 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001-09-28 and 2001-11-02
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-conform study and according to guideline; no purity info, probably techn. pure material was tested
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 1996
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: David Hall Limited, Burton-on-Trent, Staffordshire, UK
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 300 to 450 g
- Housing: individually or in pairs in solid-floor polypropylene cages furnished with woodflakes
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal and epicutaneous
- Vehicle:
- other: liquid paraffin
- Concentration / amount:
- intradermal injection: 5% v/v formulation in liquid paraffin
topical application: undiluted (= 20% test susbtance in liquid paraffin)
epicutaneous, challenge: undiluted (= 20% test susbtance in liquid paraffin) as well as 10% test substance in liquid paraffin - Route:
- epicutaneous, occlusive
- Vehicle:
- other: liquid paraffin
- Concentration / amount:
- intradermal injection: 5% v/v formulation in liquid paraffin
topical application: undiluted (= 20% test susbtance in liquid paraffin)
epicutaneous, challenge: undiluted (= 20% test susbtance in liquid paraffin) as well as 10% test substance in liquid paraffin - No. of animals per dose:
- Test group: 10
Control group: 5 - Details on study design:
- RANGE FINDING TESTS:
A.1 INDUCTION (intradermal)
- No. of animals: 2
- No. of exposures: 0.1 mL per injection site
- Concentrations: 1% and 5% v/v test substance in liquid paraffin
- Site: shoulder
- Evaluation (after injection): 24, 48, 72 hours and 7 days
A.2 INDUCTION (epidermal)
- No. of animals: 2 (intradermally injected with FCA 8 days earlier)
- Concentrations: 20% (undiluted), 10%, 5% and 2% v/v test substance in liquid paraffin
- Exposure period: 48 hours
- Evaluation (after dressing removal): 1, 24 and 48 hours
- Site: flanks
B. CHALLENGE EXPOSURE
- No. of animals: 2
- Concentrations: 20% (undiluted), 10%, 5% and 2% v/v test substance in liquid paraffin
- Exposure period: 24 hours
- Evaluation (after dressing removal): 1, 24 and 48 hours
- Site: flanks
MAIN STUDY
A.1 INDUCTION EXPOSURE (intradermal); on day 0
- No. of exposures: Three injections (0.1 mL) were made.
- Exposure period: single injection
- Test groups: FCA/water (1:1), 5% v/v formulation of test substance in liquid paraffin, 5% v/v formulation of test substance in a 1:1 preparation of FCA plus distilled water
- Control group: FCA/water (1:1), vehicle alone, 50% formulation of the vehicle in a 1:1 preparation of FCA plus distilled water
- Site: shoulder region
- Evaluation (after injection): 24 and 48 hours
A.1 INDUCTION EXPOSURE (epidermal); on day 7
- Test group: undiluted test material (20% v/v formulation in liquid paraffin)
- Control group: identical to that used for the test animals except that the test material was omitted
- Site: shoulder region
- Exposure period: 48 hours
- Evaluation (after dressing removal): 1 and 24 hours
B. CHALLENGE EXPOSURE; on day 21
- No. of exposures: 1
- Exposure period: 24 hours
- Test groups and control group: right flank: undiluted test material (20% v/v formulation); left flank: 10% test material in liquid paraffin
- Site: flank
- Evaluation (hr after challenge): 24 and 48 hours - Challenge controls:
- Yes
- Positive control substance(s):
- no
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 20%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 20%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: control group
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: control group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: control group
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: control group. Dose level: 20%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: control group
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: control group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: control group
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: control group. Dose level: 20%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the test, the undiluted test material (20% in liquid paraffin), produced a 0% sensitisation rate and was classified as a non-sensitizer to guinea pig skin.
- Executive summary:
The sensitization potential of the undiluted test material (20% in liquid paraffin) was assessed in a GLP-conform study according to OECD 406 and Commission Directive 96/54/EC Method B6. Ten test and five control guinea pigs were used for this study. Based on the results of the sighting tests, the concentrations of test material for the induction and challenge phases were selected as followed: intradermal induction: 5% test substance in liquid paraffin, topical induction: undiluted (20% test substance in liquid paraffin) and topical challenge: undiluted (20% test item in paraffin) and 10% test substance. In conclusion, the undiluted test material (20% in paraffin), produced a 0% (0/10) sensitisation rate and was classified as non-sensitizer to guinea pig skin.
Reference
Skin reactions after intradermal induction:
Discrete or patchy to moderate and confluent erythema was noted at the intradermal induction sites of test group animals. Discrete or patchy erythema was noted at the intradermal induction sites of control group animals.
Skin reactions after topical induction:
Discrete or patchy erythema was noted at the topical induction sites of test group animals. No evidence of erythema or oedema was noted at the topical induction sites of control group animals. Bleeding from the intradermal injection sites was noted in six test group animals and one control group animal.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The sensitization potential of the undiluted test material (20% in liquid paraffin) was assessed in a GLP-conform study according to OECD 406 and Commission Directive 96/54/EC Method B6. Ten test and five control guinea pigs were used for this study. Based on the results of the sighting tests, the concentrations of test material for the induction and challenge phases were selected as followed: intradermal induction: 5% test substance in liquid paraffin, topical induction: undiluted (20% test substance in liquid paraffin) and topical challenge: undiluted (20% in paraffin) and 10% test substance. In conclusion, the undiluted test material (20% in paraffin), produced a 0% (0/10) sensitisation rate and was classified as non-sensitizer to guinea pig skin.
Migrated from Short description of key information:
In conclusion, the test undiluted test material, produced a 0% (0/10) sensitisation rate and was classified as non-sensitizer to guinea pig skin.
Justification for selection of skin sensitisation endpoint:
One reliable study is available which is GLP/guideline compliant.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The test substance is not considered to be classified for skin sensitization under Regulation (EC) No 1272/2008 (CLP).
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