Registration Dossier
Registration Dossier
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EC number: 812-490-0 | CAS number: 1312943-21-7
Skin sensitisation
Some information in this page has been claimed confidential.
Administrative data
- 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:
- guideline study without detailed documentation
- Remarks:
- This study is included in a NONS registration and therefore has been evaluated by a relevant competent authority and is considered to be reliable.
Data source
Reference
- Reference Type:
- other: Body responsible for the Test
- Title:
- Unnamed
- Year:
- 2 005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V (Buehler)
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- This study is included in a NONS registration and therefore has been evaluated by a relevant competent authority and is considered to be reliable.
Test material
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Himalayan albino
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Induction
- Route:
- other: Topical
- Vehicle:
- corn oil
- Concentration / amount:
- 50% (w/w)
- Day(s)/duration:
- Not specified
- Adequacy of induction:
- not specified
Challenge
- Route:
- other: Not reported
- Vehicle:
- corn oil
- Concentration / amount:
- 25% w/w
- Day(s)/duration:
- Not specified
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- Number of animals in test group: 20
Number of animals in negative control group: 10 - Challenge controls:
- Concentration of test material and vehicle used for each challenge: 25% (w/w) in corn oil
- 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:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 20 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 20 %
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Reading:
- other: Not specified
- Group:
- positive control
- Dose level:
- Not specified
- Remarks on result:
- other: Positive control not specified
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 50 %
Signs of irritation during induction: Three test group animals showed slight erythema after the last topical induction application.
Evidence of sensitisation of each challenge concentration: 0
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item exhibited no positive results in the challenge tests at a concentration of 25 % w/w in corn oil. Therefore, the test item is not classified for skin sensitisation.
- Executive summary:
The test item was assessed for skin sensitisation at 50 % w/w suspension in corn oil at induction, and 25 % w/w suspension in corn for each challenge, following the Buehler method. Three test group animals showed slight erythema after the last topical induction application. However, no positive reactions were observed in the test item group at either assessment during the challenge. The test item is therefore not classified for skin sensitisation.
The study is a GLP compliant, guideline study and is suitable for assessment of this endpoint with restrictions.
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