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EC number: 605-143-8 | CAS number: 158318-67-3
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- Endpoint summary
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- Endpoint summary
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
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- Endocrine disrupter testing in aquatic vertebrates – in vivo
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- Toxicological Summary
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- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The substance contains structural elements which may lead to false-positive results regarding LLNAs.
Test material
- Reference substance name:
- methyl 8-(3-octyloxiran-2-yl)octanoate; methyl 8-[3-({3-[(3-ethyloxiran-2-yl)methyl]oxiran-2-yl}methyl)oxiran-2-yl]octanoate; methyl 8-{3-[(3-pentyloxiran-2-yl)methyl]oxiran-2-yl}octanoate
- EC Number:
- 605-143-8
- Cas Number:
- 158318-67-3
- Molecular formula:
- Unspecified (UVCB)
- IUPAC Name:
- methyl 8-(3-octyloxiran-2-yl)octanoate; methyl 8-[3-({3-[(3-ethyloxiran-2-yl)methyl]oxiran-2-yl}methyl)oxiran-2-yl]octanoate; methyl 8-{3-[(3-pentyloxiran-2-yl)methyl]oxiran-2-yl}octanoate
- 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: Envigo, NL-5800 AN Venray
- Housing: in macrolone cages, two or three animals to a cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): at least 30%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12h/12h
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5 ml of undiluted test substance
- Day(s)/duration:
- 6h
- Adequacy of induction:
- highest technically applicable concentration used
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- 0.5ml of diluted test substance (75%)
- Day(s)/duration:
- 6h
- Adequacy of induction:
- other: For the third induction, a reduced concentration (75%) of the test item was applied because of the development of increasing intensity of skin reaction observed in the test group on day 1 and 8 indicating an irritating effect of the undiluted substance
Challengeopen allclose all
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- 0.5ml of 50% test item
- Day(s)/duration:
- 6h
- Adequacy of challenge:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- 0.5ml of the 75% test item
- Day(s)/duration:
- 6h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20
- Details on study design:
- RANGE FINDING TESTS:
The test concentrations for the main study were selected based on the results of a preliminary investigation. Since none of the pre-test animals responded with skin reactions to the single treatment with the test item in concentrations of 25%, 50%, 75% and 100% (w/w) in the vehicle polyethylene glycol (PEG), the undiluted test item was determined to be used in both the induction phase and challenge phase.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 (topical application for three consecutive weeks)
- Exposure period: 6h
- Test groups: 20 animals
- Control group: 10 animals
- Site: left flank
- Frequency of applications: three-times
- Concentrations: 1st and 2nd induction: 100%, 3rd induction: 75%
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: Four weeks after the first induction
- Exposure period: 6h
- Test groups: 20 animals
- Control group: 10 animals
- Site: right cranial flank
- Concentrations: 75% (Re-challenge: 50%)
- Evaluation (hr after challenge): 24h and 48h after the challenge application.
- Challenge controls:
- The last positive control (PC) study with the reference material α-Hexylcinnamaldehyde, technical grade, 85 %, was conducted from Feb-2020 to Mar-2020.
- Positive control substance(s):
- yes
Results and discussion
- Positive control results:
- The last positive control (PC) study with the reference material α-Hexylcinnamaldehyde, technical grade, 85 %, was conducted from Feb-2020 to Mar-2020. In the PC test group, 11 of 20 guinea pigs (55 %) reacted with slight to moderate skin reactions (erythema grade 1 to 2).
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 75%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 75%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 85%
- No. with + reactions:
- 11
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Based on these inconclusive results of the non-adjuvant sensitization study, the test item cannot be classified unambiguously as skin sensitizer or non-sensitizer.
- Executive summary:
The dermal sensitizing potential of the test substance was investigated by means of the Buehler test.
The main study was performed on 30 guinea pigs in total arranged in a control group of 10 and a test group of 20 animals.
The test concentrations for the main study were selected based on the results of a preliminary investigation. Since none of the pre-test animals responded with skin reactions to the single treatment with the test item in concentrations of 25 %, 50 %, 75 % and 100 % (w/w) in the vehicle polyethylene glycol (PEG), the undiluted test item was determined to be used in both the induction phase and challenge phase.
The main study started with an induction phase including an occlusive patch topical application for 6 hours once a week for three consecutive weeks. The animals of the test group were induced twice with the 100 % (w/w) test item, whereas the animals of the control group were induced with the vehicle polyethylene glycol.
Due to occurrence of skin reactions with increasing intensity (grade 1 in 3/20 test group animals after 1st induction; grade 1 in 7/20 and grade 2 in 12/20 test group animals after 2nd induction), a reduction of test item concentration to 75 % (w/w) was determined for both the third induction treatment as well as the challenge treatment. In addition, for the third induction the application area was moved to untreated skin.
Erythema of grade 1 was observed in 4/20 test group animals after 3rd induction with the 75 % (w/w) test item, whereas 10/20 test group animals displayed erythema of grade 2 and 6/20 test group animals even grade 3 erythema.
During the induction phase, none of the ten control group animals displayed any skin reactions.
Four weeks after the first induction, the 6-hour challenge procedure was conducted with an occlusive topical application of the test item on the right cranial flank of all animals in a concentration of 75%. A vehicle exposure took place on the right caudal flank. The skin reactions were evaluated 24 hours and 48 hours after the challenge application.
All animals of the test group (20/20; 100 %) and all animals of the control group (10/10; 100 %) responded with skin reactions to the challenge treatment with the test item in differing intensities. Erythema formation was assessed with grade 1 (7/10) and grade 2 (3/10) in the control group. On the contrary, distinct reaction including even grade-3-erythema (15/20) were observed in the test group among mild to moderate erythema ranging between grades 1 and 2 (5/20) 24 and 48 hours after removal of the patches.
Due to these ambiguous findings providing indications for both irritating effects as well as a sensitizing potential of the test item, a re-challenge was performed using the same animals (test item concentration of 50 % w/w).
One week after the challenge, the 6-hour re-challenge procedure was conducted with an occlusive topical application of the test item on the left cranial flank of all animals. A vehicle exposure took place on the left caudal flank. The skin reactions were evaluated 24 hours and 48 hours after re-challenge application.
Again, all animals of the control group and all animals of the test group responded with skin reactions to the re-challenge treatment with the test item. Control animals displayed mild to moderate erythema (grade 1 and 2), whereas moderate to severe erythema (grade 2 and 3) were observed in the half of test group animals.
In both challenge experiments, stronger reactions in the test group than in the control group were observed, which may be considered as a hint for a skin sensitizing potential of the test item. However, since all animals of all groups showed a skin reaction, a delayed contact sensitization in the guinea pig can be neither excluded nor concluded based on the results of that study. Furthermore, the observed skin reactions in all animals of the control group give also evidence of an irritation potential of the chosen concentration
Based on these inconclusive results of the non-adjuvant sensitization study described in this final report, the test item cannot be classified unambiguously as skin sensitizer or non-sensitizer.
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