Registration Dossier
Registration Dossier
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EC number: 213-626-6 | CAS number: 995-33-5
Endpoint summary
Administrative data
Description of key information
The potential of4,4-bis(tert-butyldioxy)valerate(LUPEROX 230M50) to induce delayed contact hypersensitivity was evaluated in guinea pigs according to the maximization method of Magnusson and Kligman and to OECD guideline No. 406 and the principles of Good Laboratory Practice Regulations (Manciaux, 2001). Thirty guinea pigs were allocated to two groups: a control group of five males and five females and a treated group of ten males and ten females. On day 1, three pairs of intradermal injections were performed in the interscapular region of all animals:
. Freund’s complete adjuvant (FCA) diluted at 50% (v/v) with 0.9% NaCl (both groups), test substance at 25% (w/w) in corn oil or vehicle alone (control group),
. test substance at 25% (w/w) in a mixture FCA/0.9% NaCl 50150 (v/v) (treated group) or vehicle at the concentration of 50% (w/v) in a mixture FCA/0.9% NaCl 50150 (v/v) (control group).
On day 8, the undiluted test substance (treated group) or the vehicle (control group) was applied topically to the same test site, which was then covered by an occlusive dressing for 48 hours.
On day 22, all animals of the treated and control groups were challenged by a cutaneous application of the test substance at 50% (w/w) in corn oil to the right flank. The left flank served as control and received the vehicle only. Test substance and vehicle were maintained under an occlusive dressing for 24 hours. Skin reactions were evaluated approximately 24 and 48 hours after removal of the dressing.
At the end of the study, animals were killed without examination of internal organs. No skin samples were taken from the challenge application sites.
No clinical signs and no deaths were noted during the study. No well-defined cutaneous reactions were observed after the challenge application.
According to the maximization method of Magnusson and Kligman, the test substance4,4-bis(tert-butyldioxy)valerate(LUPEROX 230M50) does not induce delayed contact hypersensitivity in guinea pigs.
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study performed before the implementation of the REACH regulation
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River France, 76410 Saint-Aubin-lès-Elbeuf, France
- Age at study initiation: 1-3 months old
- Weight at study initiation: 358 ± 12 g for the males and 371 ± 17 g for the females
- Housing: housed individually in polycarbonate cages with stainless steel lid (48 cm x 27 cm x 20 cm)
- Diet: free access to 106 pelleted diet (SAFE, Villemoisson, Epinay sur-Orge, France)
- Water: water filtered by a FG Millipore membrane (0.22 micron) was provided ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 30 to 70
- Air changes (per hr):12
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal
- Vehicle:
- corn oil
- Concentration / amount:
- 25%
- Day(s)/duration:
- Day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100 %
- Day(s)/duration:
- Day 8
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 50%
- Day(s)/duration:
- Day 22
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Test group: 20
Negative control group: 10 - Details on study design:
- RANGE FINDING TESTS:
Tested concentrations:
By intradermal route: 25%, 10% and 5% (w/w)
By cutaneous route: 100% and 50% (w/w) - Challenge controls:
- The vehicle was applied under the same experimental conditions to the skin of the posterior left flank.
- Positive control substance(s):
- yes
- Remarks:
- Mercaptobenzothiazole
- Positive control results:
- Mercaptobenzothiazole induced positive skin sensitization reactions in 100% (10/10) guinea pigs
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to the maximization method of Magnusson and Kligman, LUPEROX 230M50 does not induce delayed contact hypersensitivity in guinea pigs.
- Executive summary:
The potential of LUPEROX 230M50 to induce delayed contact hypersensitivity was evaluated in guinea pigs according to the maximization method of Magnusson and Kligman and to OECD guideline No. 406 and the principles of Good Laboratory Practice Regulations. Thirty guinea pigs were allocated to two groups: a control group of five males and five females and a treated group of ten males and ten females. On day 1, three pairs of intradermal injections were performed in the interscapular region of all animals:
. Freund's complete adjuvant (FCA) diluted at 50% (v/v) with 0.9% NaCl (both groups), test substance at 25% (w/w) in corn oil or vehicle alone (control group),
. test substance at 25% (w/w) in a mixture FCA/0.9% NaCl 50150 (v/v) (treated group) or vehicle at the concentration of 50% (w/v) in a mixture FCA/0.9% NaCl 50150 (v/v) (control group).
On day 8, the undiluted test substance (treated group) or the vehicle (control group) was applied topically to the same test site, which was then covered by an occlusive dressing for 48 hours.
On day 22, all animals of the treated and control groups were challenged by a cutaneous application of the test substance at 50% (w/w) in corn oil to the right flank. The left flank served as control and received the vehicle only. Test substance and vehicle were maintained under an occlusive dressing for 24 hours. Skin reactions were evaluated approximately 24 and 48 hours after removal of the dressing.
At the end of the study, animals were killed without examination of internal organs. No skin samples were taken from the challenge application sites.
No clinical signs and no deaths were noted during the study. No well-defined cutaneous reactions were observed after the challenge application.
According to the maximization method of Magnusson and Kligman, the test substance LUPEROX 230M50 does not induce delayed contact hypersensitivity in guinea pigs.
Reference
- Clinical examinations:
No clinical signs and no deaths were observed during the study.
- Body weight:
The body weight gain of the treated animals was similar to that of the control animals
- Challenge phase - Scoring of cutaneous reactions
No relevant cutaneous reactions were observed.
Only a discrete erythema (grade 1) and/or dryness of the skin were noted on one or two flanks of a few animals of both groups.
These very slight cutaneous reactions, which were observed in only a few animals of both groups and as well on the flank receiving the test substance as on the flank receiving the vehicle,
were not attributed to delayed contact hypersensitivity.
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
No classification is warranted for skin sensitization according to CLP/GHS criteria.
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