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EC number: 938-458-7 | CAS number: 1443751-77-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-04-02 to 2012-05-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- N-(2-hydroxyethyl)decanamide; N-(2-hydroxyethyl)octanamide
- EC Number:
- 938-458-7
- Cas Number:
- 1443751-77-6
- Molecular formula:
- UVCB substance: Amides, C8-10 (even-numbered), N-hydroxyethyl
- IUPAC Name:
- N-(2-hydroxyethyl)decanamide; N-(2-hydroxyethyl)octanamide
- Test material form:
- solid: flakes
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Species/strain: guinea pigs/ Dunkin-Hartley
- Source: Charles River Laboratories, D.88353 Kißlegg
- Age at study initiation: 37 days
- Weight at study initiation: 330 – 382 g (excluding positive control group) Positive control group: 319 – 441 g
- Housing: in pairs in MAKROLON cages (MZK 80/25) with granulated textured wood as bedding
- Diet (e.g. ad libitum): Commercial diet, ssniff® Ms-H V2233, ad libitum
- Water (e.g. ad libitum): Tap water (in drinking bottles), ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 55% ± 15%
- Photoperiod (hrs dark / hrs light): Artificial light, sequence being 12 hours light, 12 hours dark
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: sesame oil
- Concentration / amount:
- Intradermal induction: 0.5 % of the test item, in sesame oil
Dermal induction: 75 % of the test item, in sesame oil
Challenge: 1 % of the test item, in sesame oil
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: sesame oil
- Concentration / amount:
- Intradermal induction: 0.5 % of the test item, in sesame oil
Dermal induction: 75 % of the test item, in sesame oil
Challenge: 1 % of the test item, in sesame oil
- No. of animals per dose:
- Number of animals in the test group: 10
Number of animals in the negative control group: 5
Number of animals in the dose range finding study: 8 - Details on study design:
- RANGE FINDING TESTS:
Two animals were treated intradermally with a concentration of 0.01, 0.1, 0.5, 1, 5 or 10% of the test item and the control vehicle (vehicle: sesame oil)
perliquidum). Six animals were treated topically with concentrations of 1, 5, 10, 25, 50 and 75%% of the test item and the control
vehicle for 24 or 48 hours.
MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal (day 0)
- No. of exposures: 3 pairs of intradermal injections of 0.1 mL
Test group:
Injection 1: a 1:1 mixture (v/v) FCA/physiological saline
Injection 2: a 0.5 % concentration of the test item in sesame oil chosen
Injection 3: a 0.5 % concentration of the test item formulated in a 1:1 mixture (v/v) FCA/physiological saline
Control group:
Injection 1: a 1:1 mixture (v/v) FCA/physiological saline
Injection 2: 100 % sesame oil
Injection 3: a 50 % (v/v) formulation of sesame oil in a 1:1 (v/v) mixture FCAIphysiological saline
Topical Application (day 7)
The shoulder region of the same animals was shaved again one day before the treatments.
Test Group:
The test item was suspended in sesame oil at a concentration of 75 %. A patch was fully loaded with 0.5 mL of the prepared test item,
applied to the test area and held in contact by an occlusive dressing for 48 hours.
Control Group:
A patch was fully loaded with 0.5 mL of the vehicle sesame oil and applied to the test area and held in contact by an occlusive
dressing for 48 hours.
B. CHALLENGE EXPOSURE (day 21)
Test and Control Group:
Two weeks after the topical application (corresponds to a monitoring period of 21 days) the flanks of the same animals were shaved and depilated for a further topical application using the patch-test technique.
The test item was suspended in sesame oil at a concentration of 1 %. A patch, loaded with 0.5 mL of the prepared test item was applied.
The filter paper containing the test item was applied to the left flank, the filter paper with the vehicle to the right flank of the animal (exposure time: 24 hours). 21 hours after the filter paper had been removed, no cleaning of the treated skin was necessary.
The skin reaction was observed and recorded 24, 48 and 72 hours after patch removal.
- Challenge controls:
- The test item was suspended in sesame oil at a concentration of 1 %. A patch, loaded with 0.5 mL of the prepared test item was applied sesame oil to the left flank of the animals and a patch loaded with 0.5 mL of the vehicle to the right flank (intraspecific control), respectively. The patches were held in contact by an occlusive dressing for 24 hours.
- Positive control substance(s):
- yes
- Remarks:
- α-hexyl cinnamic aldehyde, 85%, was dissolved in sesame oil for phase 1 and 3. This group was carried out concurrently with this study during May 2012
Results and discussion
- Positive control results:
- The Sensitisation rate after application of the positive control substanceα-hexyl cinnamic aldehyde, 85%, was 100 %, confirming the
reliability of the test system.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1 % . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1 % . No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1 %. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no.
Any other information on results incl. tables
Skin reaction after induction exposure:
Intradermal Induction (24hours reading):
Erythema grade 2 in all test animals
No signs of irritation were recorded for the control animals.
Intradermal Induction (48 hours reading):
Erythema grade 2 in all test animals
No signs of irritation were recorded for the control animals.
Dermal Induction (48 hours exposure, occlusive):
Immediately after removing the patch: Erythema grade 2 in all test animals
24 hours after removing the patch: Erythema grade 2 in all test animals
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
- Conclusions:
- In this study, Amides, C8-10, N-(hydroxyethyl), is not a dermal sensitiser.
- Executive summary:
In a dermal sensitisation study according to OECD TG 406, 1992) with Amides, C8-10, N-(hydroxyethyl) in sesame oil, young adult Dunkin-Hartley guinea pigs were tested using the Maximization test method. Positive control substance was α-hexyl cinnamic aldehyde, 85% with a sensitisation rate of 100 %.
Moderate skin reactions were observed after intradermal induction (0.5 %) and dermal induction (75 %) in the test substance animals. After challenge exposure (1 %) no skin reactions were observed in test or control animals at any observation time. Therefore the sensitisation rate was 0 %.
For the challenge concentration, which is the highest non-irritant dose, 1 % of the test item was used.
In this study, Amides, C8-10, N-(hydroxyethyl), is not a dermal sensitiser.
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