Registration Dossier
Registration Dossier
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EC number: 701-350-3 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 6th November - 12th November 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- A Buehler study was conducted for research and development purposes. However, in the interest of promotong the 3R principle it would be unethical to run another in vivo study to the LLNA method.
Test material
- Reference substance name:
- 3-sec-[C15-18-(branched and linear)-alk-2-enyl]pyrrolidine-2,5-dione
- EC Number:
- 701-350-3
- Molecular formula:
- Not possible to assign, UVCB
- IUPAC Name:
- 3-sec-[C15-18-(branched and linear)-alk-2-enyl]pyrrolidine-2,5-dione
- Test material form:
- liquid
- Details on test material:
- - Appearance: brown liquid
- Storage: room temperature, in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- Prior to use, all animals were acclimated for at least five days. Animals were individually housed
in wire mesh suspension cages. The animals were maintained on a 12-hour cycle light controlled
room, at a temperature of 64° - 79°F and a relative humidity of 30-70%.
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.4 mL at a 20% concentration
- Day(s)/duration:
- six hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 5%
- Day(s)/duration:
- 14
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20 animals in test group,
6 control animals - Details on study design:
- 0.4 ml of the test substance at a 20% concentration diluted in mineral oil directly into Hilltop Chambers® and applying
them to the clipped left shoulder of twenty albino guinea pigs in the following manner: The
animals were held gently, and the chambers were applied as quickly as possible to the clipped left
shoulder. The chambers were secured with Micropore tape and further secured with Kendall
adhesive tape. Approximately six hours later, the tape and chambers were removed. Two
additional induction doses were conducted following the same procedure, at weekly intervals.
Two weeks after the final application the animals received a topical primary challenge dose (6
hour contact) of X-16151, Batch #: R17-2934 at 5% concentration diluted in mineral oil, on a naive
site located on the right shoulder. Animals were scored for irritation at 24 and 48 hours after
initiation of the primary challenge application.
Ten guinea pigs served as a naive control group, and remained untreated through the induction
phase. Six naive control animals received only the primary challenge dose, at a 5% concentration
diluted in mineral oil. The four remaining guinea pigs were designated for a re-challenge, if
necessary. - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- 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:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Remarks on result:
- no indication of skin sensitisation
- Group:
- positive control
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test susbtance did not induce skin sensitization
- Executive summary:
The test substance was evaluated for sensitization potential by applying 0.4 ml at a 20% concentration diluted in mineral oil directly into Hilltop Chambers® and applying them to the clipped left shoulder of twenty albino guinea pigs in the following manner: The animals were held gently, and the chambers were applied as quickly as possible to the clipped left
shoulder. The chambers were secured with Micropore tape and further secured with Kendall adhesive tape. Approximately six hours later, the tape and chambers were removed. Two additional induction doses were conducted following the same procedure, at weekly intervals.
Two weeks after the final application the animals received a topical primary challenge dose (6 hour contact) of the test substance at 5% concentration diluted in mineral oil, on a naive site located on the right shoulder. Animals were scored for irritation at 24 and 48 hours after initiation of the primary challenge application.
Ten guinea pigs served as a naive control group, and remained untreated through the induction phase. Six naive control animals received only the primary challenge dose, at a 5% concentration diluted in mineral oil. The four remaining guinea pigs were designated for a re-challenge, if necessary.
Following primary challenge of test substance at 5% concentration, the incidence of grade 1 response or greater in the test group (0 of 20) was compared to that of the naive control group (0 of 6). The incidence and severity of these responses were not significantly greater than those produced by the naive control group indicating that sensitization had not been induced.
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