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EC number: 411-930-5 | CAS number: 106917-31-1 SANDUVOR 3058; SANDUVOR 3058 LIQ.
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 12 May 1981
- Deviations:
- no
- Remarks:
- Study conducted in 1991,when TG 406 (12 May1981) was in place, prior to TG 406 (17 July1992) introducing positive control substances. Thus, the test was considered reliable despite the lack of a positive control
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- study performed before LLNA method was established
Test material
- Reference substance name:
- 1-acetyl-4-(3-dodecyl-2,5-dioxo-1-pyrrolidinyl)-2,2,6,6-tetramethylpiperidine
- EC Number:
- 411-930-5
- EC Name:
- 1-acetyl-4-(3-dodecyl-2,5-dioxo-1-pyrrolidinyl)-2,2,6,6-tetramethylpiperidine
- Cas Number:
- 106917-31-1
- Molecular formula:
- C27H48N2O3
- IUPAC Name:
- 1-(1-acetyl-2,2,6,6-tetramethylpiperidin-4-yl)-3-dodecylpyrrolidine-2,5-dione
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann; Versuchstierzucht, Borchen
- Females (if applicable) nulliparous and non-pregnant: yes
- Microbiological status of animals, when known: SPF
- Weight at study initiation: 352+/-22 g
- Housing: 5 animals/cage (macrolon type IV)
- Diet (e.g. ad libitum): Ssniff G 4 (Ssniff Spezialfutter GmbH, Soest), ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-3°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES:
From: 30.10. To: 07.12.1990
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- corn oil
- Concentration / amount:
- Concentration of test material and vehicle used at intradermal induction:
50 % FCA in H2O; Test substance (2,5 %) in vehicle Test substance (2,5 %) in FCA (diluted with vehicle 1:1) - Day(s)/duration:
- 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- Concentration of test material and vehicle used at epicutaneous induction:
Test substance 100 % FCA : Freund's Complete Adjuvant H2O: demineralized water; Vehicle: corn oil MEH 56 - Day(s)/duration:
- 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Concentration / amount:
- Concentration of test material and vehicle used for each challenge: a) Test substance 100 % b) Test substance 100 %
- Day(s)/duration:
- 1
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- Concentration of test material and vehicle used for each challenge: a) Test substance 100 % b) Test substance 100 %
- Day(s)/duration:
- 1
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Number of animals in test group: 20 Number of animals in negative control group: 10
- Challenge controls:
- 2
- Positive control substance(s):
- not specified
- Remarks:
- The study has been conducted in 1991 prior to implementation of TG 406 (July1992) introducing reliability checks with substances knowing to have sensitisation properties. Thus, the test was considered reliable despite the lack of a positive control
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 10
- Total no. in group:
- 20
- Remarks on result:
- other: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100 %. No with. + reactions: 10.0. Total no. in groups: 20.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 11
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 %. No with. + reactions: 11.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- 1st reading
- Group:
- positive control
- Dose level:
- not tested
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
Signs of skin irritation during induction
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- The substance showed to be sensitizing.
- Executive summary:
The sensitizing properties of the test substance were investigated in a Magnusson & Kligman test according to OECD Guideline 406. As a result of the test, 11 out of 20 animals of the test group showed sensitization, thus the substance is to be regarded as skin-sensitizer.
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