Registration Dossier
Registration Dossier
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EC number: 432-130-2 | CAS number: 119345-01-6
Endpoint summary
Administrative data
Description of key information
Skin Sensitisation: The test substance was not sensitising to the skin of guinea pigs in a guinea pig maximisation test. [EU Method B.6, GLP]
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study obtained through inquiry process; SNIF file obtained from ECHA.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Use of data >12 years received after successful inquiry, no new study has been conducted.
- Species:
- guinea pig
- Strain:
- Himalayan
- Sex:
- not specified
- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
Induction lntradermal: 0.1 mL
1) solution CFA: physiological saline (50: 50)
2) 1% test substance in TWEEN 80
3) 1% test substance in solution CFA: physiological saline (50: 50)
Induction epidermale:
75% tets substance in TWEEN 80
Concentration of test substance material and vehicle used for each challenge: 75% test substance in TWEEN 80 - Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
Induction lntradermal: 0.1 mL
1) solution CFA: physiological saline (50: 50)
2) 1% test substance in TWEEN 80
3) 1% test substance in solution CFA: physiological saline (50: 50)
Induction epidermale:
75% tets substance 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 - Positive control substance(s):
- no
- 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.
- Key result
- 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.
- Group:
- positive control
- Remarks on result:
- other: not specified
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was found to be not sensitising under the conditions of the test.
- Executive summary:
The test substance was tested to be not sensitising to the skin of guinea pigs in a GLP study according to EU Method B.6.
Reference
Maximum concentration not causing irritating effects in preliminary test: 75%
No signs of irritation during induction, no evidence of sensitisation of each challenge concentration. Further, no mortality and no clinical signs or body weight changes have been observerd during the test.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The sensitising potential of the test substance has been determined in a GLP compliant test with guinea pigs according to EU Method B.6. In this study the test substance was not sensitising to the skin of guinea pigs and does therefore not need to be classified according to Regulation 1272/2008/EC.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Skin sensitisation
According to the European regulation (EC) No. 1272/2008, the test material does not meet the criteria for classification and will not require labelling as sensitising to the skin.
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