Registration Dossier
Registration Dossier
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EC number: 946-398-8 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- 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
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- 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:
- The experimental start dates were 16 Feb 2016 (OECD) and 23 Feb 2016 (EPA), the experimental completion date was 04 Apr 2016 (OECD) and 01 Apr 2016 (EPA).
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The surface tension of test item prepared at 90 % saturation in water was determined to be 32.0 mN/m at 22.0 ± 0.5°C; literature data suggested LLNA study may give false positive result, thus a confirmatory Buehler test was conducted.
Test material
- Reference substance name:
- Tall Oil Fatty Acids, compounds with 2-(2-aminoethoxy) ethanol
- Molecular formula:
- Too complex
- IUPAC Name:
- Tall Oil Fatty Acids, compounds with 2-(2-aminoethoxy) ethanol
- Test material form:
- liquid
- Details on test material:
- - Appearance/ Physical State: light brown slightly viscous liquid
- Storage conditions: room temperature, in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Remarks:
- Hartley-derived albino guinea pigs
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Receipt
On 16 Feb 2016, 44 male and 44 female Hartley-derived albino guinea pigs were received from Charles River Laboratories, Inc., St. Constant, QC. The animals were examined and weighed on the day following receipt.
Justification for Test System and Number of Animals
The Hartley-derived guinea pig was chosen as the animal model for this study as it is an accepted rodent species for preclinical toxicity testing by regulatory agencies.
The total number of animals used in this study was considered to be the minimum required to properly characterize the effects of the test substance. This study was designed such that it did not require an unnecessary number of animals to accomplish its objectives.
At this time, studies in laboratory animals provide the best available basis for extrapolation to humans and are required to support regulatory submissions. Acceptable models which do not use live animals currently do not exist.
Animal Identification
Each animal was identified by a cage card and plastic ear tag.
Environmental Acclimation
The animals were acclimated to their designated housing for at least 7 days before the first day of dosing.
Selection, Assignment, and Disposition of Animals
The animals chosen for study were arbitrarily selected from healthy animals. All animals received a detailed pretest observation prior to dosing. Only healthy animals were chosen for study use.
The male range-finding animals were approximately 5 weeks of age on the day prior to dosing with body weights of 372 grams and 380 grams. The female range-finding animals were approximately 6 weeks of age on the day prior to dosing with body weights of 325 grams and 348 grams.
The male main phase animals were approximately 6 weeks of age on the day prior to Induction 1 dosing with body weights ranging from 343 grams to 481 grams. The female main phase animals were approximately 7 weeks of age on the day prior to Induction 1 dosing with body weights ranging from 337 grams to 424 grams.
The male second range-finding animals were approximately 9 weeks of age on the day prior to dosing with body weights of 510 grams and 561 grams. The female second range-finding animals were approximately 10 weeks of age on the day prior to dosing with body weights of 447 grams and 473 grams.
The male third range-finding animals were approximately 10 weeks of age on the day prior to dosing with body weights of 609 grams and 650 grams. The female third range-finding animals were approximately 11 weeks of age on the day prior to dosing with body weights of 493 grams and 515 grams.
The disposition of all animals was documented in the Study Records.
Husbandry
Housing
The animals were pair housed (2 animals of the same sex and same dosing group together) throughout the study in polycarbonate cages containing direct bedding material. Housing and care were as specified in the USDA Animal Welfare Act (9 CFR, Parts 1, 2, and 3) and as described in the Guide for the Care and Use of Laboratory Animals from the National Research Council.
Environmental Conditions
Temperatures of 70°F to 73°F (21°C to 23°C) with a relative humidity of 40% to 52% were maintained. A 12 hour light/12 hour dark cycle was maintained, except when interrupted for designated procedures. Ten or greater air changes per hour with 100% fresh air (no air recirculation) were maintained in the animal rooms.
Food
PMI Nutrition International Certified Guinea Pig Chow No. 5026 was provided ad libitum throughout the study, except during designated procedures. The feed was analyzed by the supplier for nutritional components and environmental contaminants. Results of the dietary analyses were provided by the supplier and are on file at the Testing Facility. It is considered that there are no known contaminants in the feed that would interfere with the objectives of the study.
Water
Municipal tap water after treatment by reverse osmosis and ultraviolet irradiation was freely available to each animal via an automatic watering system, except during designated procedures. Water bottles were provided when required. The water is analyzed semi-annually for microbial contamination and for total dissolved solids, hardness, and various environmental contaminants. Results of these analyses are maintained on file at the Testing Facility. It is considered that there are no known contaminants in the water that could interfere with the outcome of the study.
Animal Enrichment
Beginning at receipt, guinea pigs were pair housed in solid bottom cages containing direct bedding material. As an alternative, guinea pigs were individually housed in solid bottom cages containing direct bedding material. When individually housed, a hiding comfort device (PVC pipe) was provided. In addition, a timothy hay cube was provided to each animal at least weekly.
Veterinary Care
Veterinary care was available throughout the study. No veterinary examinations were required or medicinal treatments were administered during the study.
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- once per week, for 3 consecutive weeks
- Adequacy of induction:
- other: There was a clear demonstration of sensitization potential in the guinea pig based on increasing irritation during induction
Challenge
- No.:
- #1
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- propylene glycol
- Remarks:
- 75% test substance in propylene glycol
- Concentration / amount:
- Following a 2-week rest period after the end of the Induction, a challenge was performed whereby the 20 test and 10 previously untreated (naïve) challenge control guinea pigs were topically treated with 75% test substance in propylene glycol
- Day(s)/duration:
- 48
- Adequacy of challenge:
- other: At 48 h dermal scores of 1 or 2 were noted in 20/20 animals. Challenge control animals showed no signs of irritation with scores of 0. Group mean dermal scores were higher in the test animals (1.5 to 1.8) as compared to challenge control animals (0.0).
- No. of animals per dose:
- In the induction phase, 10 male and 10 female guinea pigs were topically treated
The challenge was performed whereby the 20 test and 10 previously untreated (naïve) challenge control guinea pigs were topically treated - Details on study design:
- This study was performed in accordance with the United States Code of Federal Regulations, Title 40, Parts 792: Good Laboratory Practice (GLP) Standards and as accepted by Regulatory Authorities throughout the European Union (OECD Principles of Good Laboratory Practice), and Japan (MAFF and METI), and other countries that are signatories to the OECD Mutual Acceptance of Data Agreement.
Exceptions from the above regulations are listed below.
• Characterization of the test substance was performed by the Sponsor or Sponsor subcontractor according to established SOPs, controls, and approved test methodologies to ensure integrity and validity of the results generated; these analyses were not conducted in compliance with the GLP or Good Manufacturing Practice (GMP) regulations.
• Concentration, stability, and homogeneity of the test substance formulations were not determined in this study.
• Concentration, stability, and homogeneity of the α-Hexylcinnamaldehyde (HCA) formulations were not determined in this study.
This study was conducted in accordance with the procedures described herein. All deviations authorized/acknowledged by the Study Director are documented in the Study Records. The report represents an accurate and complete record of the results obtained.
There were no deviations from the above regulations that affected the overall integrity of the study or the interpretation of the study results and conclusions. - Challenge controls:
- Following challenge with 75% test substance in propylene glycol, dermal scores of 1 or 2 were noted in 18/20 test animals at the 24-hour scoring interval. At the 48-hour scoring interval, dermal scores of 1 or 2 were noted in 20/20 test animals. The challenge control animals showed no signs of irritation with scores of 0. Group mean dermal scores were higher in the test animals (1.5 to 1.8) as compared to challenge control animals (0.0).
- Positive control substance(s):
- yes
- Remarks:
- α-Hexylcinnamaldehyde (HCA)
Results and discussion
- Positive control results:
- The results of the HCA positive control study demonstrated that a valid test was performed and indicated that the test design would detect potential contact sensitizers.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 18
- Total no. in group:
- 20
- Clinical observations:
- Following challenge with 75% test substance in propylene glycol, dermal scores of 1 or 2 were noted in 18/20 test animals at the 24-hour scoring interval.
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- Based on the results of this study, the test substance is considered to be a contact sensitizer in guinea pigs. The criterion for sensitization (dermal scores ≥ 1 in at least 15% of the test animals) was met at challenge as 80% of the test animals responded with a dermal score of 2.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- Following challenge with 75% test substance in propylene glycol, at the 48-hour scoring interval, dermal scores of 1 or 2 were noted in 20/20 test animals.
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- Based on the results of this study, the test substance is considered to be a contact sensitizer in guinea pigs. The criterion for sensitization (dermal scores ≥ 1 in at least 15% of the test animals) was met at challenge as 80% of the test animals responded with a dermal score of 2.
Any other information on results incl. tables
RESULTS
Mortality
No mortality occurred during the study.
Range-Finding Phases
(Table 1, Table 2, and Table 3)
Based on the initial range-finding phase, the 100% as received concentration was considered appropriate for conducting the induction phase based on ± (slight patchy erythema) scores through 48 hours. During induction, irritation was observed at the 100% concentration; therefore, prior to challenge, a second range-finding phase was conducted by repeating the 75%, 50%, and 25% concentrations with the addition of a 12.5% concentration. The second range‑finding phase produced increased dermal irritation (±, 1, and 2 erythema scores) at the lower concentrations with only 1 animal showing an erythema score of 1 at the 75% concentration. Based on these results, a third range-finding phase was added at the same concentrations as the second range-finding phase to assess the variability between the first and second range-finding phase results. For the third range-finding phase, the test substance was warmed in an attempt to produce a more homogeneous bulk test substance prior to removal for dilution. The third range-finding phase produced erythema scores of ± at all 3 concentrations and it was determined that the 75% concentration was appropriate as the highest non-irritating concentration for the challenge phase.
Table 1
Topical range finding data
GROUP |
ANIMAL NO./SEX BODY WEIGHT (G) |
RANGE-FINDING DERMAL SCORES |
|||||||
100%a |
75%b |
50%b |
25%b |
||||||
24 HOURS |
48 HOURS |
24 HOURS |
48 HOURS |
24 HOURS |
48 HOURS |
24 HOURS |
48 HOURS |
||
RANGE-FINDING |
6064/M |
± |
± |
0 |
0 |
0 |
0 |
0 |
0 |
(380) |
|
|
|
|
|
|
|
|
|
6065/M |
± |
± |
0 |
0 |
0 |
0 |
0 |
0 |
|
(372) |
|
|
|
|
|
|
|
|
|
6066/F |
0 |
± |
0 |
0 |
0 |
0 |
0 |
0 |
|
(348) |
|
|
|
|
|
|
|
|
|
6067/F |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
(325) |
|
|
|
|
|
|
|
|
|
aAS RECEIVED. bTHE VEHICLE USED WAS PROPYLENE GLYCOL. |
Table 2
Second
Topical Range-Finding Data
GROUP |
ANIMAL NO./SEX BODY WEIGHT (G) |
SECOND RANGE-FINDING DERMAL SCORES |
|||||||
75%a |
50%a |
25a |
12.5a |
||||||
24 HOURS |
48 HOURS |
24 HOURS |
48 HOURS |
24 HOURS |
48 HOURS |
24 HOURS |
48 HOURS |
||
SECOND RANGE-FINDING |
6022/M |
1 |
1 |
2 |
0 |
2 |
2 |
2 |
2 |
(510) |
|
|
|
|
|
|
|
|
|
6023/M |
0 |
0 |
1 |
1 |
1 |
1 |
1 |
1 |
|
(561) |
|
|
|
|
|
|
|
|
|
6108/F |
0 |
0 |
1 |
1 |
0 |
0 |
1 |
1 |
|
(447) |
|
|
|
|
|
|
|
|
|
6109/F |
0 |
0 |
± |
± |
± |
± |
0 |
1 |
|
(473) |
|
|
|
|
|
|
|
|
|
aTHE VEHICLE USED WAS PROPYLENE GLYCOL. |
Table 3
Third
Topical Range-Finding Data
GROUP |
ANIMAL NO./SEX BODY WEIGHT (G) |
THIRD RANGE-FINDING DERMAL SCORES |
|||||||
75%a |
50%a |
25a |
12.5a |
||||||
24 HOURS |
48 HOURS |
24 HOURS |
48 HOURS |
24 HOURS |
48 HOURS |
24 HOURS |
48 HOURS |
||
THIRD RANGE-FINDING |
6062/M |
0 |
0 |
0 |
0 |
± |
0 |
± |
0 |
(609) |
|
|
|
|
|
|
|
|
|
6063/M |
± |
0 |
0 |
0 |
± |
0 |
± |
± |
|
(650) |
|
|
|
|
|
|
|
|
|
6106/F |
0 |
0 |
± |
0 |
± |
0 |
0 |
0 |
|
(515) |
|
|
|
|
|
|
|
|
|
6107/F |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
(493) |
|
|
|
|
|
|
|
|
|
aTHE VEHICLE USED WAS PROPYLENE GLYCOL. |
Induction Phase
(Table 4)
Dermal scores of ± (slight patchy erythema) or 1 (slight, but confluent or moderate patchy erythema) were present at Induction 1 for all test animals. One animal (male Animal No. 6025) had an erythema score of 0 during Induction 2, while all others had erythema scores of 1 or 2 with 3 animals also showing signs of very slight edema. By Induction 3, male Animal No. 6025 had an erythema score of 1 with all others showing signs of erythema 2 or maximized erythema grade 3 (notable dermal lesions). Additional dermal irritation was observed consisting of blanching, eschar, and/or edema for the test animals.
Table 4
Individual
Induction Data
GROUP |
ANIMAL NO./SEX |
DERMAL SCORES |
|||||
INDUCTION 1 |
INDUCTION 2 |
INDUCTION 3 |
|||||
100%a |
100%a |
100%a |
|||||
24 HOURS |
48 HOURS |
24 HOURS |
48 HOURS |
24 HOURS |
48 HOURS |
||
TEST |
6024/M |
1 |
1 |
1 |
1 |
M-3BLA-2, ED-2 |
2BLA-1, ED-1 |
6025/M |
1 |
1 |
0 |
0 |
1 |
1 |
|
6026/M |
1 |
1 |
2ED-1 |
2ED-1 |
M-3BLA-3, ED-2 |
M-3BLA-1, ED-2, ES-2 |
|
6027/M |
1 |
1 |
2ED-1 |
2ED-1 |
M-3BLA-3, ED-2 |
M-3BLA-3, ED-2 |
|
6028/M |
1 |
1 |
2 |
2 |
2ES-1, BLA-1, ED-2 |
M-3ED-2, ES-3 |
|
6029/M |
1 |
1 |
2 |
2 |
2 |
2ED-1 |
|
6030/M |
1 |
1 |
2 |
2 |
M-3BLA-3, ED-2 |
M-3ED-2, ES-4 |
|
6031/M |
1 |
± |
1 |
2 |
2ED-1 |
2ED-1 |
|
6032/M |
± |
± |
2 |
2 |
M-3BLA-2, ED-1 |
M-3ED-2, ES-3 |
|
6033/M |
1 |
1 |
± |
± |
2ED-1 |
M-3BLA-4, ED-2 |
|
6068/F |
1 |
1 |
2ED-1 |
2ED-1 |
2ED-1, ES-1 |
M-3BLA-3, ED-2, ES-1 |
|
6069/F |
1 |
1 |
2 |
2 |
2 |
2ED-1 |
|
6070/F |
± |
± |
2 |
2 |
M-3ED-2, ES-3 |
M-3ED-3, ES-4 |
|
6071/F |
1 |
1 |
2 |
2 |
M-3ED-2, ES-3 |
M-3ED-2, ES-3 |
|
6072/F |
1 |
1 |
1 |
1 |
2BLA-1, ED-1 |
M-3BLA-2, ED-2 |
|
6073/F |
± |
± |
2 |
2 |
M-3ES-2, BLA-1, ED-2 |
M-3ES-3, BLA-1, ED-2 |
|
6074/F |
1 |
1 |
2 |
2 |
M-3ES-4, ED-2 |
M-3ES-4, ED-2 |
|
6075/F |
1 |
1 |
2 |
2 |
M-3ES-4, ED-2 |
M-3ES-4, ED-2 |
|
6076/F |
± |
± |
2 |
2 |
M-3ES-4, ED-3 |
M-3ES-4, ED-3 |
|
6077/F |
1 |
1 |
2 |
2 |
2ES-1, BLA-1, ED-2 |
M-3ES-4, ED-3 |
|
aAS RECEIVED. |
GROUP |
ANIMAL NO./SEX |
DERMAL SCORES |
|||||
INDUCTION 1 |
INDUCTION 2 |
INDUCTION 3 |
|||||
5.0%a |
5.0%a |
5.0%a |
|||||
24 HOURS |
48 HOURS |
24 HOURS |
48 HOURS |
24 HOURS |
48 HOURS |
||
HCA TEST |
6034/M |
±BLA-1 |
1BLA-1 |
M-3ES-3 |
M-3ES-3 |
2BLA-1 |
2BLA-1 |
6035/M |
± |
1 |
M-3ES-3 |
M-3ES-3 |
2 |
2BLA-1 |
|
6036/M |
2 |
2 |
M-3ES-2, BLA-1 |
M-3ES-2, BLA-1 |
2BLA-1, ED-1 |
2BLA-1, ED-1 |
|
6037/M |
2 |
2 |
M-3ES-3 |
M-3ES-3 |
2BLA-1, ED-1 |
2BLA-1, ED-1 |
|
6038/M |
2BLA-1 |
2BLA-1 |
M-3ES-3 |
M-3ES-3 |
2 |
2BLA-1 |
|
6078/F |
2 |
2ED-1 |
M-3ES-3 |
M-3ES-3 |
2BLA-1 |
2BLA-1 |
|
6079/F |
2BLA-1 |
2BLA-1 |
M-3ES-3 |
M-3ES-3 |
2 |
2 |
|
6080/F |
2 |
2 |
M-3ES-2 |
M-3ES-2 |
2BLA-1, ED-1 |
2BLA-1, ED-1 |
|
6081/F |
1BLA-1 |
1BLA-1 |
M-3ES-3 |
M-3ES-3 |
2BLA-1 |
2BLA-1 |
|
6082/F |
1 |
1 |
M-3ES-3 |
M-3ES-3 |
2BLA-1 |
2BLA-1 |
|
aTHE VEHICLE USED WAS ETHANOL. |
Challenge Phase
(Table 5)
Following challenge with 75% test substance in propylene glycol, dermal scores of 1 or 2 were noted in 18/20 test animals at the 24-hour scoring interval. At the 48-hour scoring interval, dermal scores of 1 or 2 were noted in 20/20 test animals. The challenge control animals showed no signs of irritation with scores of 0. Group mean dermal scores were higher in the test animals (1.5 to 1.8) as compared to challenge control animals (0.0).
Following challenge with 2.5% w/v HCA in acetone, dermal scores of 1 or 2 were noted in 10/10 HCA test animals at the 48-hour scoring interval. Dermal reactions in the HCA control animals were limited to scores of ± in 3/10 at the 24-hour interval and none had irritation (erythema 0) by the 48-hour interval. Group mean dermal scores were higher in the HCA test animals (0.4 to 1.6) compared to the HCA control animals (0.2 and 0.0).
Following challenge with 1.0% w/v HCA in acetone, dermal scores of 1 or 2 were noted in 10/10 HCA test animals at the 48-hour scoring interval. Dermal reactions in the HCA control animals were limited to scores of ± in 4/10 and 1 in 1/10 by the 48-hour interval. Group mean dermal scores were higher in the HCA test animals (0.4 to 1.5) compared to the HCA control animals (0.2 to 0.3).
Table 5
Individual
Challenge Data
GROUP |
ANIMAL NO./SEX |
DERMAL SCORES |
|
|
|||
75%a |
|
|
|||||
24 HOURS |
48 HOURS |
|
|
|
|
||
TEST |
6024/M |
0 |
1 |
|
|
|
|
6025/M |
1 |
1 |
|
|
|
|
|
6026/M |
2ED-1 |
2ED-1 |
|
|
|
|
|
6027/M |
1 |
2 |
|
|
|
|
|
6028/M |
2ED-1 |
2ED-1 |
|
|
|
|
|
6029/M |
2ED-1 |
2 |
|
|
|
|
|
6030/M |
0 |
1 |
|
|
|
|
|
6031/M |
1 |
1 |
|
|
|
|
|
6032/M |
1 |
2 |
|
|
|
|
|
6033/M |
1 |
2 |
|
|
|
|
|
6068/F |
2ED-1 |
2ED-1 |
|
|
|
|
|
6069/F |
2ED-1 |
2 |
|
|
|
|
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6070/F |
2ED-1 |
2ED-1 |
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6071/F |
2ED-1 |
2ED-1 |
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6072/F |
2 |
2 |
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6073/F |
2 |
2 |
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6074/F |
1 |
2 |
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6075/F |
2 |
2 |
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6076/F |
2 |
2 |
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6077/F |
2 |
2 |
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MEAN |
1.5 |
1.8 |
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aTHE VEHICLE USED WAS PROPYLENE GLYCOL. |
GROUP |
ANIMAL NO./SEX |
DERMAL SCORES |
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75%a |
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|||||
24 HOURS |
48 HOURS |
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||
CHALLENGE CONTROL |
6039/M |
0 |
0 |
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6040/M |
0 |
0 |
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6041/M |
0 |
0 |
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6042/M |
0 |
0 |
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6043/M |
0 |
0 |
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6083/F |
0 |
0 |
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6084/F |
0 |
0 |
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6085/F |
0 |
0 |
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6086/F |
0 |
0 |
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6087/F |
0 |
0 |
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MEAN |
0 |
0 |
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aVEHICLE USED WAS PROPYLENE GLYCOL |
GROUP |
ANIMAL NO./SEX |
DERMAL SCORES |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
2.5%a |
1.0a |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
24 HOURS |
48 HOURS |
24 HOURS |
48 HOURS |
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HCA TEST |
6034/M |
± |
1 |
± |
1 |
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6036/M |
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2 |
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2 |
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6037/M |
2 |
2 |
2 |
2 |
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6038/M |
± |
2 |
± |
2 |
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6078/F |
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1 |
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1 |
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6079/F |
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1 |
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1 |
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6080/F |
± |
2 |
± |
2 |
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6081/F |
0 |
1 |
0 |
1 |
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6082/F |
± |
2 |
± |
2 |
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||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
MEAN |
0.4 |
1.6 |
0.4 |
1.5 |
|
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
FOR PURPOSES OF CALCULATION, ± = 0.5. aTHE VEHICLE USED WAS ACETONE.
|
Body Weights
(Appendix 4)
No test item - related effects on body weight were observed in the test animals during the study. Weight gain in the animals throughout the study interval was indicative of good health in the test and control animals.
One test animal (male Animal No. 6032) showed a slight body weight loss (2 grams) between Day 28 and Day 34. The Day 34 body weight was collected in preparation for a rechallenge phase that was not needed based on the study requirements were met.
Appendix 4
Individual
Body Weight Data
GROUP |
ANIMAL NO./SEX |
BODY WEIGHT (G) |
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
DAY -1 |
DAY 28 |
34a |
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|
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
TEST |
6024/M |
450 |
570 |
603 |
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||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
6025/M |
454 |
615 |
641 |
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
6026/M |
402 |
552 |
582 |
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
6027/M |
431 |
638 |
663 |
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
6028/M |
449 |
702 |
740 |
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
6029/M |
444 |
691 |
730 |
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
6030/M |
443 |
672 |
710 |
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
6031/M |
419 |
618 |
652 |
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
6032/M |
416 |
588 |
586 |
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
6033/M |
409 |
636 |
654 |
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
6068/F |
383 |
536 |
566 |
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
6069/F |
388 |
583 |
607 |
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
6070/F |
384 |
533 |
538 |
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
6071/F |
399 |
592 |
616 |
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
6072/F |
366 |
534 |
555 |
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
6073/F |
385 |
567 |
604 |
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
6074/F |
386 |
550 |
559 |
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
6075/F |
386 |
577 |
618 |
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
6076/F |
374 |
486 |
498 |
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
6077/F |
421 |
557 |
591 |
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
HCA TEST |
6034/M |
419 |
622 |
- |
|
|
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
6035/M |
444 |
647 |
- |
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
6036/M |
459 |
707 |
- |
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
6037/M |
430 |
642 |
- |
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
6038/M |
442 |
513 |
- |
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
6078/F |
424 |
593 |
- |
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
6079/F |
381 |
520 |
- |
|
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6080/F |
398 |
550 |
- |
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6081/F |
354 |
460 |
- |
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6082/F |
380 |
580 |
- |
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NOTE: - = NOT APPLICABLE. aANIMALS WERE WEIGHED FOR POSSIBLE RECHALLENGE PHASE DOSING.
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Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- The skin sensitisation potential of the test item was assessed in accordance with OECD Guideline 406. Based on the results of this study, the test substance is considered to be a contact sensitizer in guinea pigs. The criterion for sensitization (dermal scores ≥ 1 in at least 15% of the test animals) was met at challenge as 80% of the test animals responded with a dermal score of 2. There was a clear demonstration of sensitization potential in the guinea pig based on increasing irritation during induction with a similar dermal response at challenge, as would be expected in the guinea pig when sensitized to a test substance. The results of the HCA positive control study demonstrated that a valid test was performed and indicated that the test design would detect potential contact sensitizers.
- Executive summary:
The dermal sensitization potential of the test substance was evaluated in Hartley-derived albino guinea pigs. In the induction phase, 10 male and 10 female guinea pigs were topically treated with the test substance, as received,once per week, for 3 consecutive weeks. Following a 2-week rest period, a challenge was performed whereby the 20 test and 10 previously untreated (naïve) challenge control guinea pigs were topically treated with 75% test item in propylene glycol.
An α-Hexylcinnamaldehyde (HCA) positive control group consisting of 10 HCA test and 10 HCA control guinea pigs was included in this study. The animals were treated as above with the HCA test animals receiving 5% w/v HCA in ethanol for induction and 2.5% and 1.0% w/v HCA in acetone for challenge.
Test item
Following challenge with 75%the test item in propylene glycol, dermal scores of 1 or 2 were noted in 18/20 test animals at the 24-hour scoring interval. At the 48-hour scoring interval, dermal scores of 1 or 2 were noted in 20/20 test animals. The challenge control animals showed no signs of irritation with scores of 0. Group mean dermal scores were higher in the test animals (1.5 to 1.8) as compared to challenge control animals (0.0).
α-Hexylcinnamaldehyde (HCA)
Following challenge with 2.5% w/v HCA in acetone, dermal scores of 1 or 2 were noted in 10/10 HCA test animals at the 48-hour scoring interval. Dermal reactions in the HCA control animals were limited to scores of ± in 3/10 at the 24-hour interval and none had irritation (erythema 0) by the 48-hour interval. Group mean dermal scores were higher in the HCA test animals (0.4 to 1.6) compared to the HCA control animals (0.2 and 0.0).
Following challenge with 1.0% w/v HCA in acetone, dermal scores of 1 or 2 were noted in 10/10 HCA test animals at the 48-hour scoring interval. Dermal reactions in the HCA control animals were limited to scores of ± in 4/10 and 1 in 1/10 by the 48-hour interval. Group mean dermal scores were higher in the HCA test animals (0.4 to 1.5) compared to the HCA control animals (0.2 to 0.3).
Conclusion
Based on the results of this study,the test item is considered to be a contact sensitizer in guinea pigs. The criterion for sensitization (dermal scores ≥ 1 in at least 15% of the test animals) was met at challenge as 80% of the test animals responded with a dermal score of 2. There was a clear demonstration of sensitization potential in the guinea pig based on increasing irritation during induction with a similar dermal response at challenge, as would be expected in the guinea pig when sensitized to a test substance. The results of the HCA positive control study demonstrated that a valid test was performed and indicated that the test design would detect potential contact sensitizers.
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