Registration Dossier
Registration Dossier
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EC number: 402-990-3 | CAS number: 163702-01-0 ESACURE KIP 100; ESACURE KIP 150
Endpoint summary
Administrative data
Description of key information
Study conducted to recognised testing guidelines with GLP certification.
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:
- 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- 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:
- The study was conducted prior to the adoption of the LLNA guideline.
- Species:
- guinea pig
- Strain:
- other: Albino, not otherwise specified
- Route:
- intradermal
- Vehicle:
- paraffin oil
- Concentration / amount:
- 0.1% test material in 0.1ml preparation
- Day(s)/duration:
- 1
- Adequacy of induction:
- not specified
- Route:
- intradermal
- Vehicle:
- paraffin oil
- Concentration / amount:
- 0.2% test material in 0.1ml preparation
- Day(s)/duration:
- 1
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 0.5ml test material at 60% in preparation
- Day(s)/duration:
- 1
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 0.5ml test material at 60% in preparation
- No. of animals per dose:
- Number of animals in test group: 20
Number of animals in negative control group: 20 - 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:
- no indication of skin sensitisation
- 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:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Referenceopen allclose all
Injection provoked a weak to moderate irritation during the preliominary study. Topical occlusive route provoked a weak to moderate irritation due probably by tearing.
Evidence of sensitisation of each challenge concentration:
None.
Other observations:
Positive control group with positive effect due to DNCB.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The substance does not meet the criteria for classification in accordance with the classification, labelling and packaging regulation (EC 1272/2008).
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.
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