Registration Dossier
Registration Dossier
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EC number: 432-130-2 | CAS number: 119345-01-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Not specified
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP (taken from SNIF file). Registrant referring to studies >12 years old at the permission of ECHA.
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- -
- EC Number:
- 432-130-2
- EC Name:
- -
- Cas Number:
- 119345-01-6
- Molecular formula:
- Not applicable ( a generic molecular formula cannot be provided for this UVCB substance)
- IUPAC Name:
- Reaction products of phosphorous trichloride, with 1,1′-biphenyl and 2,4-bis(1,1-dimethylethyl)phenol
- Details on test material:
- No data
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Himalayan
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No data
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
Induction lntradermal:
1) 0.1 ml solution CFA: physiological saline (50: 50)
2) 1% test substance in TWEEN 80
3) 1% substance of essal in una solution CFA: physiological saline (50: 50)
Induction epidermale: 75% in TWEEN 80
Concentration of test substance material and vehicle used for each challenge: 75% test substance in TWEEN 80
Challengeopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
Induction lntradermal:
1) 0.1 ml solution CFA: physiological saline (50: 50)
2) 1% test substance in TWEEN 80
3) 1% substance of essal in una solution CFA: physiological saline (50: 50)
Induction epidermale: 75% in TWEEN 80
Concentration of test substance material and vehicle used for each challenge: 75% test substance in TWEEN 80
- No. of animals per dose:
- Number of animals in test group: 20
Number of animals In negative control group: 10 - Details on study design:
- No data
- Challenge controls:
- No data
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 75%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 75%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 75%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 75%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 75%
Signs of irritation during induction: test group: 0/20 animals displayed oedema or erythema after the induction.
Negative Control group: 0/5 animals displayed oedema or erythema after the induction.
Evidence of sensitisation of each challenge concentration: 75%: 0 / 20 animals
Other observations: mortality: no mortality during the test.
Clinical signs: No clinical signs have been observed during the test.
Body weight: No changes were noted.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Not classified
- Executive summary:
Information from migrated NONS file, as per inquiry number 06-0000020725-70-0000, permission to refer granted by ECHA.
Study conducted to GLP (taken from SNIF file). Registrant referring to studies >12 years old at the permission of ECHA.
Not sensitising. The substance is not classified.
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