Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 431-620-3 | CAS number: 162537-11-3
Endpoint summary
Administrative data
Description of key information
No signs of skin sensitisation were observed at the challenge concentrations.
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:
- Between November 1998 and 27 December 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Directive 92/69/EEC, B6 (Magnusson and Kligman maximisation test).
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The test was carried out before a formal requirement for an LLNA test was in place.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- not specified
- Route:
- intradermal and epicutaneous
- Vehicle:
- arachis oil
- Concentration / amount:
- a)Intradermal Induction:
0.5% (w/v) in arachis oil BP
0.5% (w/v) in Freund's Complete Adjuvant plus distilled water in the ratio 1:1
b)Topical Induction: 50% (w/w) in arachis oil BP.
Concentration of test material and vehicle used for each challenge:
a) 2% (w/w) in arachis oil BP
b) 1% (w/w) in arachis oil BP - Adequacy of induction:
- highest technically applicable concentration used
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
a)Intradermal Induction: 0.5% (w/v) in arachis oil BP
0.5% (w/v) in Freund's Complete
Adjuvant plus distilled water in the ratio 1:1.
b)Topical Induction: 50% (w/w)* in arachis oil BP.
*maximum concentration practical for topical application.
Concentration of test material and vehicle used for each challenge:
a) 2% (w/w) in arachis oil BP
b) 1% (w/w) in arachis oil BP - No. of animals per dose:
- Number of animals in test group: 10
Number of animals in negative control group: 5 - Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 2 %
- 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: 2 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1 %
- 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: 1 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 2 %
- 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: 2 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1 %
- 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: 1 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 2 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 2 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 2 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 2 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Interpretation of results:
- GHS criteria not met
Reference
Maximum concentration not causing irritating effects in preliminary test: 2 %
Signs of irritation during induction:
Intradermal Induction:
Well-defined or moderate to severe erythema was noted at the
intradermal injection sites of all test group animals at the
24 and 48-hour observations. Very slight to well-defined
erythema was noted at the intradermal injection sites of all
control group animals during this period.
Topical Induction:
Very slight to well-defined erythema, with or without very
slight to slight oedema, was noted at the topical induction
sites of all test group animals at the 1-hour observation.
Very slight to well-defined erythema, with or without very
slight oedema, persisted at the topical induction sites of
all test group animals at the 24-hour observation. Bleeding
from the intradermal injection sites was noted in eight test
group animals with subsequent small superficial scattered or
dark brown/black coloured scabs in four test group animals
at the 24-hour observation.
Very slight erythema was noted at the topical induction
sites of two control group animals at the 1-hour
observation. Bleeding from the intradermal induction sites
was noted in four control group animals.
Evidence of sensitisation of each challenge concentration:
Number of animals showing evidence of senitisation at each
challenge concentration: 0/9.
2% w/w in Arachis oil BP:
No skin reactions were noted at the challenge sites of the
test or control group animals at the 24 or 48-hour
observations.
1% w/w in arachis oil BP:
No skin reactions were noted at the challenge sites of the
test or control group animals at the 24 or 48-hour
observations.
Other observations:
Bodyweight gains of animals in the test group, between day 0
and day 24, were comparable to those in the control group.
One test group animal was found dead on Day 22. This was not
considered to affect the purpose or integrity of the study.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
