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EC number: 240-540-6 | CAS number: 16485-10-2
- 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:
- 1998-06-09 to 1998-07-09 (application period of the main test)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted July 17, 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 1996
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-6 (Skin Sensitisation)
- Version / remarks:
- revised November 1984
- Deviations:
- no
- Principles of method if other than guideline:
- The study was performed based on the method of BUEHLER EV (1965): Delayed Contact Hypersensitivity in the Guinea Pigs. Arch Dermat 91: 171-177.
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- A guinea pig skin sensitization test (Buehler method), which was conducted in 1999 in compliance with OECD 406 guideline and under GLP, is already available for the test item. According to the Guidance on Information Requirements R.7a, section R.7.3.4.1 (pp 283-4) “existing data of good quality that were generated before 10 May 2017, or for which the study was initiated before 10 May 2017, and derived from such tests are acceptable; and if these tests provide clear results that are adequate for classification, even when a conclusion on potency (Cat. 1A or not) cannot be drawn, they will preclude the need for further in vivo testing.” In addition, information on the (non-)sensitization potential of the test item can be drawn by its long-standing use in personal care products.
Based on the long-term use of Panthenol in Personal Care products without evidence of sensitization, augmented with an available skin sensitization test in guinea pigs of good quality, the conduct of another animal test is not justified
Test material
- Reference substance name:
- Panthenol , DL-form
- EC Number:
- 240-540-6
- EC Name:
- Panthenol , DL-form
- Cas Number:
- 16485-10-2
- Molecular formula:
- C9H19NO4
- IUPAC Name:
- 2,4-dihydroxy-N-(3-hydroxypropyl)-3,3-dimethylbutanamide
- Reference substance name:
- DL-Panthenol
- IUPAC Name:
- DL-Panthenol
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
female Pirbright White, Dunkin Hartley Crl:(HA)BR [SPF] guinea pigs
- Source: Charles River GmbH, Sulzfeld, FRG
- Age at study initiation: young adult animals, no further data
- Weight at study initiation: 323 - 374 g
- Housing: 5 animals per cage, in stainless steel wire mesh cages with plastic-coated grating, floor area 40 cm x 51 cm
- Diet: Kliba Laboratory Diet (Rabbit- Guinea Pig Maintenance Diet; Supplier: Klingentalmühle AG, Kaiseraugst, Switzerland), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 25 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- undiluted
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- undiluted
- No. of animals per dose:
- 20 animals (test group)
10 animals (control groups) - Details on study design:
- RANGE FINDING TESTS:
The pretest was performed with 4 female animals.
The test substance was applied to four clipped sites of the flanks of each animal for 2 x 6 hours under an occlusive dressing. Each animal was applied the undiluted test substance as well as solutions of the test substance in bidistilled water at concentrations of 75%, 50%, and 25%, each. The test material was applied 2 times (one application per week) on the same application area, respectively. The skin was read at 6 and 30 hours after beginning of application.
No signs of skin irritation were noted in any animal with any concentration at any reading. Thus, the undiluted test substance was selected as test concentration for the main study for both induction and challenge.
MAIN STUDY
Number of animals per control group: 10.
Number of animals of the test group: 20.
According to the authors, a second control group (control group 2) has been intended for a potential rechallenge in case of borderline results at the challenge.
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: days 0, 7 and 14
- Test groups: 0.5 mL of the undiluted test substance
- Control group: the control groups were not treated, since the test substance was applied unchanged and thus no vehicle was used.
- Site: anterior left flank
- Frequency of applications: one application per week
- Duration: 6 hours
- Concentrations: undiluted
- Reading: 24 h after the removal of the patch
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 28
- Exposure period: 6 hours
- Test groups: 0.5 mL of the undiluted test substance
- Control group: 0.5 mL of the undiluted test substance (control group 1), untreated (control group 2)
- Site: right flank
- Concentrations: undiluted
- Evaluation (hr after challenge): 24 and 48 h after the removal of the patch
Since no borderline results were observed, a rechallenge was not performed.
OTHER:
determination of body weight
Evaluation criteria
The evaluation of the results is based on the criteria of the Commission Directive 96/54/EC of July 30, 1996 for the 22nd Amendment of the Directive 67/548 EEC (Publication No. L 248, p. 228 - 229, 1996).
The number of animals with skin findings at 24 and/or 48 hours after the removal of the patch is taken into account for the determination of the sensitization rate.
The evaluation "sensitizing" results if at least 15 per cent of the test animals exhibit skin reactions. - Challenge controls:
- A separate positive control study was routinely conducted with alpha-hexylcinnamaldehyde techn. 85% (1998-02-19 to 1998 03-27) in accordance with GLP guidelines and the Testing guidelines mentioned above:
- two control groups of 10 animals each
- a test group of 20 animals
- three induction applications with alpha-hexylcinnamaldehyde, 25% in Lutrol E 400
- challenge with alpha-hexylcinnamaldehyde, 10% in Lutrol E 400
- rechallenge with alpha-hexylcinnamaldehyde, 10% in Lutrol E 400 - Positive control substance(s):
- yes
- Remarks:
- alpha-hexylcinnamaldehyde techn. 85%
Results and discussion
- Positive control results:
- The positive control study was valid; see freetext below.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Any other information on results incl. tables
Main study:
Induction:
The first, second and third induction with the undiluted test substance did not cause any signs of skin irritation in all test group animals.
Challenge:
The number of animals with skin findings after the challenge is summarized in the following table:
Group |
Challenge (Test substance undiluted) skin reactions |
Control group 1 |
0/10 |
Test group |
0/20 |
x/y: number of positive reactions/number of animals tested (reading at 24 h and/or 48 h after the removal of the patch)
Body weights:
The expected body weight gain was generally observed in the course of the study.
Conclusion:
Based on the results of this study and applying the evaluation criteria it was concluded that D,L-Panthenol does not have a sensitizing effect on the skin of the guinea pig in the BUEHLER Test under the test conditions chosen.
Positive control study (BASF report No. 32H0158/982065)
The positive control with Alpha-Hexylcinnamaldehyde techn. 85% showed that the chosen guinea pig strain was able to detect sensitizing compounds under the laboratory conditions chosen.
The number of animals with skin findings after the challenge and after the rechallenge is summarized in the following table:
Challenge |
Rechallenge |
|||||||||||
a-Hexylcinnamaldehyde 10% in Lutrol E 400 DAB |
Vehicle control Lutrol E 400 DAB |
a-Hexylcinnamaldehyde 10% in Lutrol E 400 DAB |
Vehicle control Lutrol E 400 DAB |
|||||||||
24 h |
48 h |
Total |
24 h |
48 h |
total |
24 h |
48 h |
Total |
24 h |
48 h |
total |
|
Control group 1 |
0/10 |
0/10 |
0/10 |
0/10 |
0/10 |
0/10 |
0/10 |
0/10 |
0/10 |
0/10 |
0/10 |
0/10 |
Control group 2 |
No application of test substance |
0/10 |
0/10 |
0/10 |
0/10 |
0/10 |
0/10 |
0/10 |
0/10 |
0/10 |
||
Test group |
4/19 |
2/19 |
4/19 |
0/19 |
0/19 |
0/19 |
5/19 |
3/19 |
5/19 |
0/19 |
0/19 |
0/19 |
x/y: number of positive reactions/number of animals tested (reading at 24 h and/or 48 h after the removal of the patch)
(*) 1 animal of the test group died 25 days after the beginning of the study. Macroscopic examination revealed that the cause of death was not substance-related.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the evaluation criteria the results of this study show that DL-Panthenol does not have a sensitizing effect on the skin of the guinea pig in the BUEHLER Test under the test conditions chosen.
- Executive summary:
DL-Panthenol was tested for its sensitizing effect on the skin of the guinea pig in the BUEHLER Test according to OECD 406 and under GLP.
The first, second and third induction with the undiluted test substance did not cause any signs of skin irritation in all test group animals.
A challenge was performed 14 days after the last induction.
The number of animals with skin findings after the challenge is summarized in the following table:
Group
Challenge
(Test substance undiluted)
skin reactions
Control group 1
0/10
Test group
0/20
x/y: number of positive reactions/number of animals tested (reading at 24 h and/or 48 h after the removal of the patch)
Based on the results of this study and applying the evaluation criteria it was concluded that DL-Panthenol does not have a sensitizing effect on the skin of the guinea pig in the BUEHLER Test under the test conditions chosen.
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