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EC number: 256-176-6 | CAS number: 44992-01-0
Toxicological information
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Start of the experimental phase: January 31, 2013; Termination of the in-life phase: May 10, 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented GLP guideline study performed on a well identidied test substance..
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- [2-(acryloyloxy)ethyl]trimethylammonium chloride
- EC Number:
- 256-176-6
- EC Name:
- [2-(acryloyloxy)ethyl]trimethylammonium chloride
- Cas Number:
- 44992-01-0
- Molecular formula:
- C8H16NO2.Cl
- IUPAC Name:
- Trimethyl[2-(prop-2-enoyloxy)ethyl]azanium chloride
- Details on test material:
- - Name of test material (as cited in study report): Flocryl ADAM / MC80
- Substance type: organic
- Physical state: clear, colourless slight viscous liquid
- Analytical purity:80.1% test substance, 19.9% water
- Impurities (identity and concentrations): Not identified
- Composition of test material, percentage of components: 80.1%
- Purity test date: 17-09-2013
- Lot/batch No.: 4.49.12.23.B
- Stability under test conditions: stable
- Storage condition of test material: stored in contact with air, storage temperature not exceeded 30°C, protected from light
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services Germany GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: 31 to 32 days
- Weight at study initiation: 303 to 361 g (excluding positive control); positive control: 316 to 370 g
- Housing: in pairs
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 55% ± 15%
- Air changes (per hr): 15 to 20 times
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark cycle
IN-LIFE DATES: From: January 31, 2013 To: May 10, 2013
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: aqua ad iniectabilia
- Concentration / amount:
- Stage 1: intradermal: 0.1% solution of Flocryl ADAM / MC80
Stage 2: epicutaneous: 10% solution of Flocryl ADAM / MC80
Stage 3: epicutaneous: 1% solution of Flocryl ADAM / MC80
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: aqua ad iniectabilia
- Concentration / amount:
- Stage 1: intradermal: 0.1% solution of Flocryl ADAM / MC80
Stage 2: epicutaneous: 10% solution of Flocryl ADAM / MC80
Stage 3: epicutaneous: 1% solution of Flocryl ADAM / MC80
- No. of animals per dose:
- Vehicle control (aqua ad iniectabilia): 10
Flocryl ADAM / MC80: 20
Positive Control: 20 (historical background of the laboratory) - Details on study design:
- RANGE FINDING TESTS:
- Exposure: intradermal or epicutaneous
- No. of animals: 18 (intradermal: 2, epicutaneous: 16)
- Exposure period: 24 hours and 48 hours for the shaved skin, 24 hours for the shaved and depilated skin
- Concentrations: intradermal: 0.01, 0.1, 0.5, 1, 5, 10% of Flocryl ADAM / MC80; epicutaneous: 1, 5, 10, 25, 50, 75, 100% of Flocryl ADAM / MC80
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal, epicutaneous)
- Exposure period: 48 hours (epicutaneous)
- Test groups: 1
- Control group: 1
- Site: shoulder region
- Frequency of applications: day 0: intradermal, day 7: epicutaneous
- Duration: 20 days
- Concentrations: intracutaneous: 0.1% solution of Flocryl ADAM / MC80; epicutaneous: 10% solution of Flocryl ADAM / MC80
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 21
- Exposure period: 24 hours
- Test groups: 1
- Control group: 1
- Site: left flank region (test item), right flank region (vehicle)
- Concentrations: 1% solution of Flocryl ADAM / MC80
- Evaluation (hr after challenge): 48 hours and 72 hours
OTHER: day 6: 0.5 mL sodium laurylsulfate in order to induce a local irritation - Positive control substance(s):
- yes
- Remarks:
- α-hexyl cinnamic aldehyde
Results and discussion
- Positive control results:
- Sensitising reaction in all animals in form of a moderate and confluent erythema (positive control data are obtained from historical background of the laboratory)
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 0.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 0.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- discrete or patchy erythema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: discrete or patchy erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- discrete or patchy erythema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 0%. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: discrete or patchy erythema.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- none
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 0.0. Clinical observations: none.
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- none
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 72.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 0.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- discrete or patchy erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1%. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: discrete or patchy erythema.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- discrete or patchy erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.1%. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: discrete or patchy erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- moderate and confluent erythema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: moderate and confluent erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- moderate and confluent erythema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 10%. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: moderate and confluent erythema.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- none
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 0.0. Clinical observations: none.
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- none
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 72.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 0.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 10%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- moderate and confluent erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 10%. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: moderate and confluent erythema.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 10%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- discrete or patchy erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 10%. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: discrete or patchy erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 100%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- moderate and confluent erythema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 100%. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: moderate and confluent erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- positive control
- Dose level:
- 100%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- discrete or patchy erythema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: positive control. Dose level: 100%. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: discrete or patchy erythema.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.01%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- moderate and confluent erythema
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.01%. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: moderate and confluent erythema.
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- positive control
- Dose level:
- 0.01%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- moderate and confluent erythema
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 72.0. Group: positive control. Dose level: 0.01%. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: moderate and confluent erythema.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The challenge with 2 mL of a 1% solution of Flocryl ADAM / MC80 in aqua ad iniectabilia/animal revealed no skin irritation in any animal and, thus, the test item had no sensitising properties.
The vehicle control revealed no skin reactions.
Animals of the same strain treated with α-hexyl cinnamic aldehyde in sesame oil exhibited a sensitising reaction in all animals in form of a moderate and confluent erythema (grade 2).
Under the present test conditions, Flocryl ADAM / MC80 was found to be not sensitising to guinea pigs in a test model according to MAGNUSSON and KLIGMAN.
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