Registration Dossier
Registration Dossier
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EC number: 217-192-9 | CAS number: 1770-80-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017 timelines: study initiation: March 1st, Experimental start: March 15th, experimental completion: June 15th, study completion: August 23rd
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
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 (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The Buehler assay was judged to be the most adequate methodology, considering the substance’s insolubility and density.
Test material
- Reference substance name:
- Dibutyl 1,4,5,6,7,7-hexachlorobicyclo[2.2.1]hept-5-ene-2,3-dicarboxylate
- EC Number:
- 217-192-9
- EC Name:
- Dibutyl 1,4,5,6,7,7-hexachlorobicyclo[2.2.1]hept-5-ene-2,3-dicarboxylate
- Cas Number:
- 1770-80-5
- Molecular formula:
- C17H20Cl6O4
- IUPAC Name:
- dibutyl 1,4,5,6,7,7-hexachlorobicyclo[2.2.1]hept-5-ene-2,3-dicarboxylate
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Crl:HA
- Sex:
- male
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5 mL, 100%
- Day(s)/duration:
- 6 hours, once a week for 3 weeks
- Adequacy of induction:
- highest technically applicable concentration used
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: acetone
- Concentration / amount:
- 0.5 mL at 1% in vehicle
- Day(s)/duration:
- 6 hours, 1 time
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20 (treated), 10 (negative control)
- Challenge controls:
- 0.5 mL of vehicle
- Positive control substance(s):
- yes
- Remarks:
- mercaptobenzothiazole
Results and discussion
- Positive control results:
- 60 to 65% sensitized (among 20 animals)
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 mL, 1% in vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No effect
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- n/a
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No effect
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- mercaptobenzothiazole 25% in vaseline
- No. with + reactions:
- 25
- Total no. in group:
- 40
- Clinical observations:
- Not data provided
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
induction: erythema grade 1 in 3, 4 and 6/20 animals after 1st, 2nd and 3rd induction, resp.
challenge: no erythema or edema in any treated animal at 24 and 48h post challenge
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- When tested according to the Buehler protocol in Guinea pigs, the test item induced no sign of sensitization in 20 animals.
The test item was not a skin sensitizer in this study.
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