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EC number: 680-602-3 | CAS number: 98133-47-2
- 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 tp 1998.07.09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- 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)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-6 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The study was performed based on the method of BUEHLER EV (1965): Delayed Contact Hypersensitivity in the Guinea Pigs. Arch Dermat 91: 171-177
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
- Test material form:
- liquid: viscous
- Remarks:
- At room temperature: high viscous oil, colourless (crystallized)
- Details on test material:
- Batch No: LJ. No 28740-94 B1 and B2
Date of manufacturing: January 26, 1998
Constituent 1
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)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5 mL of the test substance applied to each animal
- Day(s)/duration:
- days 0, 7 and 14 on teh same application area
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5 mL of the test substance was applied for 6 hours to the right flank of each animal
- Day(s)/duration:
- 14 days after the third induction
- No. of animals per dose:
- Number of animals per control group : 10
Number of animals of the test group : 20 - Details on study design:
- INDUCTION
3 inductions were conducted
Application frequency:
• one application per week ; days 0, 7 and 14 on the same application area
2 x 2 cm gauze patches (6 layers surgical gauze Ph . Eur. from Lohmann GmbH & Co.
KG) containing the test substance were applied to the skin of the flank under an
occlusive dressing . The dressing consisted of rubberized linen patches (4 x 4 cm from
Russka), patches of Idealbinde (5 x 5 cm from Pfälzische Verbandstoff-Fabrik) and
Fixomull® Stretch (adhesive fleece) from Beiersdorf AG.
0.5 ml of the test substance was applied to each animal .
The control groups were not treated, since the test substance was applied unchanged
and thus no vehicle was used .
Duration of exposure :
• 6 hours
Site of application:
• anterior left flan k
Reading:
• 24 h after the removal of the patc h
CHALLENGE
A challenge was carried out 14 days after the third induction .
2 x 2 cm gauze patches (6 layers surgical gauze Ph . Eur. from Lohmann GmbH & Co.
KG) containing the test substance were applied to the skin of the flank under an
occlusive dressing . The dressing consisted of rubberized linen patches (4 x 4 cm from
Russka), patches of Idealbinde (5 x 5 cm from Pfälzische Verbandstoff-Fabrik) and
Fixomull® Stretch (adhesive fleece) from Beiersdorf AG .
0.5 ml of the test substance was applied for 6 hours to the right flank of each animal .
The test group and control group 1 were treated with the test substance (control group 2
remained untreated).
Readings :
• 24 and 48 h after the removal of the patch - Positive control substance(s):
- no
- Remarks:
- A positive control (with Alpha-Hexylcinnamaldehyde techn. 85%) is not included in this study but a separate study is performed twice a year in the laboratory.
Results and discussion
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:
- no indication of skin sensitisation
- 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:
- no indication of skin sensitisation
- 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:
- no indication of skin sensitisation
- 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:
- no indication of skin sensitisation
- Reading:
- other:
- Group:
- positive control
- Dose level:
- Not specified
- Clinical observations:
- Not specified
- Remarks on result:
- positive indication of skin sensitisation
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:
- GHS criteria not met
- 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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