Registration Dossier
Registration Dossier
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EC number: 466-070-3 | CAS number: 209995-38-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Test performed in the year 2006.
Test material
- Reference substance name:
- -
- EC Number:
- 466-070-3
- EC Name:
- -
- Cas Number:
- 209995-38-0
- Molecular formula:
- C8H5F3O2
- IUPAC Name:
- 2-(2,4,5-trifluorophenyl)acetic acid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- cotton seed oil
- Concentration / amount:
- 5%
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- cotton seed oil
- Concentration / amount:
- 25%
- No. of animals per dose:
- Number of animals in test group: 10
Number of animals in negative control group: 5
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:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 25 %
Signs of irritation during induction:
Induction 1:
after 24H,
at injection site 2 erythema grade 1 in 5 of 10 animals
at injection site 3 erythema grade 1 in 8 of 10 animals
after 48H
at injection site 2 erythema grade 1 in 4 of 10 animals
at injection site 3 erythema grade 1 in 8 of 10 animals
No other signs of irritation were observed in any of the animals (Induction first stage).
No signs of irritation were observed in any of the animals after topical application (Induction second stage).
No signs of irritation were observed after the challenge. The maximum % of animals sensitized was 0%.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance at the tested concentration caused no reactions identified as sensitization. It does not require the labelling for sensitising properties as the sensitization rate was less than 30%.
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