Registration Dossier
Registration Dossier
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EC number: 939-526-9 | CAS number: 90506-73-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 1989-02-28 to 1989-04-01
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Read-across from guideline study, tested with the source substance Monopalmityl phosphate. In accordance to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- no pretreatment of test site before epicutaneous induction to induce irritation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- no pretreatment of test site before epicutaneous induction to induce irritation
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 3539-43-3 (Hexadecyl dihydrogen phosphate)
- IUPAC Name:
- 3539-43-3 (Hexadecyl dihydrogen phosphate)
- Reference substance name:
- Hexadecyl dihydrogen phosphate
- EC Number:
- 222-581-1
- EC Name:
- Hexadecyl dihydrogen phosphate
- Cas Number:
- 3539-43-3
- IUPAC Name:
- hexadecyl dihydrogen phosphate
- Reference substance name:
- Monopalmityl phosphate
- IUPAC Name:
- Monopalmityl phosphate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Monopalmityl phosphate
- Analytical purity: 99.5%
Constituent 1
Constituent 2
Constituent 3
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: no data
- Weight at study initiation: 382-455 g
- Housing: suspended cages with wire mesh floors
- Diet (e.g. ad libitum): vitamin C enriched guinea pig diet, ad libitum, hay was given weekly
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 12 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): ca. 21°C
- Humidity (%): 30-70%
- Air changes (per hr): ca. 15/h
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- intradermal induction: 0.5% in water for irrigation
epicutaneous induction: 40% in distilled water
first challenge: 20%, 40% in distilled water
second challenge: 1%, 10% in distilled water
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- intradermal induction: 0.5% in water for irrigation
epicutaneous induction: 40% in distilled water
first challenge: 20%, 40% in distilled water
second challenge: 1%, 10% in distilled water
- No. of animals per dose:
- 10 control animals
20 test animals - Details on study design:
- RANGE FINDING TESTS:
The intradermal and topical irritancy of a range of dilutions of the test substance was investigated to identify (a) irritant test substance concentrations suitable for the induction phase of the main study and (b) non-irritant concentrations by the topical route of administration for the challenge phase.
Concentrations for intradermal injection (w/w in water for irrigation): 10%, 7.5%, 5%, 2.5%, 1%, 0.5%, 0.25%, 0.1%
Concentrations for topical application (w/w in water for irrigation): 40%, 30%, 20%, 10%
A concentration of 40% w/w in distilled water was the maximum practical concentration that could be prepared and dosed topically.
MAIN STUDY
INDUCTION EXPOSURE
Intradermal injection
A 4 x 6 cm area of dorsal skin on the scapular region of the guinea-pig was clipped free of hair with electric clippers. Three pairs of intradermal injections (0.1 mL) were made simultaneously into this area:
1. Freund's complete adjuvant diluted with an equal volume of water for irrigation
2. test substance 0.5% w/w in water for irrigation
3. test substance 0.5% w/w in a 50 : 50 mixture of Freund's complete adjuvant and water for irrigation
Topical application
One week after the injections, the same 4 x 6 cm interscapular area was clipped and shaved free of hair.
A 2 x 4 cm patch of Whatman No. 3 paper was saturated with the test substance, 40% w/w in distilled water. The patch was placed on the skin and covered by a length of impermeable plastic adhesive tape. This in turn was firmly secured by elastic adhesive bandage. The dressing was left in place for 48 h.
Control animals
Similar treatment, without test substance
B. CHALLENGE EXPOSURE
Test and control animals, topical application
The test and control animals were challenged topically two weeks after the induction period using the test substance in concentrations of 20% and 40% w/w in distilled water.
Hair was removed by clipping and then shaving from an area on the left flank of each guinea-pig. A 2 x 2 cm patch of Whatman No. 3 paper was saturated with approximately 0.2 mL of the test substance 40% w/w in distilled water and applied to an anterior site on the flank. The test substance in a concentration of 20% w/w in distilled water was applied in a similar manner to a posterior site. The patches were sealed with impermeable plastic adhesive tape to the flank for 24 h.
Rechallenge
A second challenge application was made one week later with lower concentrations: 1%, 10% were apllied in a similar manner to the right flank of the animals.
READING CHALLENGE REACTIONS
24, 48 and 72 h after removal of the patches
Scoring according to Magnusson and Kligman - Challenge controls:
- first challenge: 20%, 40%
second challenge: 1%, 10% - Positive control substance(s):
- yes
- Remarks:
- formalin
Results and discussion
- Positive control results:
- The last periodic use of a positive control substance (formalin) with the acceptable level of response in the test animals was performed on January 10, 1989.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 20%
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 20%. No with. + reactions: 4.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 40%
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 40%. No with. + reactions: 7.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 20%. No with. + reactions: 8.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 40%
- No. with + reactions:
- 13
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 40%. No with. + reactions: 13.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 20%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 20%. No with. + reactions: 1.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 40%
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 40%. No with. + reactions: 6.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 20%. No with. + reactions: 3.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 40%
- No. with + reactions:
- 10
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 40%. No with. + reactions: 10.0. Total no. in groups: 20.0.
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: . Hours after challenge: 72.0. Group: negative control. Dose level: 20%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 40%
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Remarks on result:
- other: . Hours after challenge: 72.0. Group: negative control. Dose level: 40%. No with. + reactions: 3.0. Total no. in groups: 10.0.
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Remarks on result:
- other: . Hours after challenge: 72.0. Group: test group. Dose level: 20%. No with. + reactions: 3.0. Total no. in groups: 20.0.
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 40%
- No. with + reactions:
- 9
- Total no. in group:
- 20
- Remarks on result:
- other: . Hours after challenge: 72.0. Group: test group. Dose level: 40%. No with. + reactions: 9.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1%, 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 1%, 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1%, 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 1%, 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 1%, 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 72.0. Group: negative control. Dose level: 1%, 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1%, 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 1%, 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1%, 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 1%, 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 1%, 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 72.0. Group: test group. Dose level: 1%, 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Any other information on results incl. tables
Result table
Group |
Animal number |
E = erythema O = oedema |
Scores first challenge |
Scores second challenge |
||||||||||
24 h |
48 h |
72 h |
24 h |
48 h |
72 h |
|||||||||
A |
P |
A |
P |
A |
P |
A |
P |
A |
P |
A |
P |
|||
Control animals |
1 |
E O |
1 0 |
L1 0 |
L1 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
2 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
|
3 |
E O |
1 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
|
4 |
E O |
1 0 |
0 0 |
L1 0 |
0 0 |
L1 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
|
5 |
E O |
1 0 |
L1 0 |
L1 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
|
6 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
|
7 |
E O |
1 0 |
L1 0 |
L1 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
|
8 |
E O |
1 0 |
1 0 |
1 0 |
L1 0 |
1 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
|
9 |
E O |
1 0 |
0 0 |
L1 0 |
0 0 |
L1 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
|
10 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
|
Test animals |
1 |
E O |
1 0 |
0 0 |
L1 0 |
L1 0 |
L1 0 |
L1 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
2 |
E O |
1 0 |
0 0 |
L1 0 |
0 0 |
L1 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
|
3 |
E O |
L1 0 |
0 0 |
L1 0 |
0 0 |
L1 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
|
4 |
E O |
1 0 |
1 0 |
L1 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
|
5 |
E O |
1 1 |
0 0 |
L1 0 |
0 0 |
L1 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
|
6 |
E O |
1 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
|
7 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
|
8 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
|
9 |
E O |
1 0 |
1 0 |
L1 0 |
L1 0 |
L1 0 |
L1 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
|
10 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
|
11 |
E O |
L1 0 |
L1 0 |
L1 0 |
L1 0 |
L1 0 |
L1 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
|
12 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
|
13 |
E O |
L1 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
|
14 |
E O |
1 1 |
0 0 |
L1 0 |
0 0 |
L1 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
|
15 |
E O |
1 1 |
L1 0 |
L1 0 |
0 0 |
L1 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
|
16 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
|
17 |
E O |
L1 0 |
L1 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
|
18 |
E O |
0 0 |
1 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
|
19 |
E O |
0 0 |
L1 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
|
20 |
E O |
L1 0 |
L1 0 |
L1 0 |
0 0 |
L1 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
|
L1 = localised dermal reaction, restricted to a small area of the challenge site
A = anterior site, exposed to 40% test substance in distilled water
P = posterior site, exposed to 20% test substance in distilled water
Interpretation of results
Dermal reactions in the test animals elicited by the challenge applications were compared with the findings simultaneously obtained in the control animals.
A test animal was considered to show positive evidence of delayed contact hypersensitivity if the observed dermal reaction at challenge was definitely more marked and/or persistent than the maximum reaction seen in animals of the control group.
If the dermal reaction seen in a test animal at challenge was slightly more marked and/or persistent than (but not clearly distinguishable from) the maximum reaction seen in control animals, the result for that test animal was classified as inconclusive.
A test animal was considered to show no evidence of delayed contact hypersensitivity if the dermal reaction resulting from the challenge application was the same as, or less marked and/or persistent than the maximum reaction seen in animals of the control group.
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 Monopalmityl phosphate is not a dermal sensitiser.
- Executive summary:
In a dermal sensitisation study according to OECD guideline 406 with Hexadecyl dihydrogen phosphate (Monopalmityl phosphate), Dunkin-Hartley guinea pigs were tested using the method of Magnusson and Kligman. Positive control substance was formalin.
For intradermal induction a concentration of 0. 5% was used. The test concentration used for epicutaneous induction (40% in water) was not irritating in the pretest. No SDS-pretreatment was done before epicutaneous induction. For epidermal induction, a 40% dilution of the test substance was applied
24 hours after intradermal induction and covered by occlusive dressing for 48 hours. Two test substance concentrations, 20% and 40% in water, were used for challenge (24 h, covered by occlusive dressing).Slight erythema (grade 1) was observed in both test and control animals after the first challenge, therefore a second challenge application was made one week later using lower concentrations (1% and 10% in water).
After the second challenge application no visible changes of the treated skin sites (no erythema and no edema) were observed in test or control animals at any time point (24 h, 48 h, 72 h).
In this study Hexadecyl dihydrogen phosphate (Monopalmityl phosphate) is not a dermal sensitiser.
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