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EC number: 203-846-0 | CAS number: 111-21-7
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:
- key study
- Study period:
- 27 Apr - 17 Jun 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study with acceptable restrictions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- no reliabilty check included
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- no reliabilty check included
- GLP compliance:
- yes
- Type of study:
- Buehler test
Test material
- Reference substance name:
- Fatty acids, C16-18, 1,2-ethanediylbis(oxy-2,1-ethanediyl) esters
- EC Number:
- 292-947-3
- EC Name:
- Fatty acids, C16-18, 1,2-ethanediylbis(oxy-2,1-ethanediyl) esters
- Cas Number:
- 91031-45-7
- IUPAC Name:
- 91031-45-7
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Chemical denomination: Fatty acid, C16-18, 1,2-Ethandiyl Bis
- Substance type: pure substance
- Physical state: yellowish solid
- Analytical purity: 100%
- Lot/batch No.: 62393218
- Expiration date of the lot/batch: December 31, 1994
- Storage condition of test material: dark and room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Hsd/Win:DH
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann, Borchen, Germany
- Age at study initiation: approx. 6 weeks
- Weight at study initiation: 340 g
- Housing: Groups of 2-3 animals in Makrolon Type IV cages with standard softwood bedding. Change of bedding: two times a week.
- Diet: Pelleted Altromin Maintenance Diet 3022 (Altromin GmbH, Lage, Germany), ad libitum
- Water: Tap water, ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 45-75
- Air changes (per hr): at least 8
- Photoperiod (hrs dark / hrs light): 12/12
- Other: Music during light hours
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- peanut oil
- Concentration / amount:
- Induction: 25%
Challenge: 20%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- peanut oil
- Concentration / amount:
- Induction: 25%
Challenge: 20%
- No. of animals per dose:
- 3 (preliminary), 5 (dose finding), 10 (controls), 20 (in test groups)
- Details on study design:
- PRELIMINARY STUDY
Preliminary tests were carried out to determine suitable concentrations for induction and challenge. The concentrations in a dose of 0.5 g (50%) and 0.5 mL (25%, 12.5% and 6%) were tested. The concentrations were applied on the left flanks of three animas in succession. The exposure was terminated after 6 h by removing the plaster and cleaning the skin with propylene glycol 20%.
DOSE FINDING
The non-irritating concentrations for the challenge were checked in five animals of the control group (treated with the vehicle one week before the 1st challenge). The concentrations applied on the right flank in a dose of 0.5 mL were 10%, 15%, 20% and 25%. The exposure was terminated after 6 h by removing the plaster and cleaning the skin with propylene glycol 20%. 24 and 48 hours later, dermal effects were evaluated.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: test substance in peanut oil
- Control group: peanut oil
- Site: left flank
- Frequency of applications: every 7 days
- Duration: Days 0-21
- Concentrations: 25%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 35
- Exposure period: 6 h
- Test groups: test substance in peanut oil
- Control group: test substance in peanut oil
- Site: bilaterally to both sheared flanks (caudal) of animals of the treatment and the control group
- Concentrations: 20%
- Evaluation (hr after challenge): 24, 48 and 72 h after patch removal
EVALUATION CRITERIA
- see Table 1 - Challenge controls:
- The control group is actually a challenge control
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 20%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- slight dermal effects at the left or right flank
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 20%. No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: slight dermal effects at the left or right flank.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- slight dermal effects at the left flank
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 20%. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: slight dermal effects at the left flank.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 20%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- slight dermal effects at the left or right flank
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 20%. No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: slight dermal effects at the left or right flank.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 9
- Total no. in group:
- 20
- Clinical observations:
- slight dermal effects in 8 animals and weak dermal effects in one animal at the left and/or right flank
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 20%. No with. + reactions: 9.0. Total no. in groups: 20.0. Clinical observations: slight dermal effects in 8 animals and weak dermal effects in one animal at the left and/or right flank.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 20%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 20%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Any other information on results incl. tables
PRELIMINARY STUDY
In the preliminary study no reaction of the test substance was observed up to 50% in the test animals. According to the author a solution of 25% was considered the minimal irritating concentration. The concentration chosen for the induction period was 25%.
DOSE FINDING
The tested solutions did not provoke any skin reactions at the 5 dose finding animals. The concentration chosen for challenge was 20%.
MAIN STUDY
Induction readings:
1 hour after the 3rd induction, three animals of the control group (15 animals: 10 control animals plus 5 animals out of the dose finding group) and four animals of the treatment group showed weak skin reactions. Only for one animal out of the treatment group slight skin reactions were observed after 24 hours (see Table 2).
Table 2. Skin reactions 1 and 24 hours (left flank) after 3rd induction.
Skin reaction/ Value |
1 hour c (15) / t (20) |
24 hours c (15) / t (20) |
||
none / 0 |
12 |
16 |
15 |
19 |
slight / 0+ |
0 |
0 |
0 |
1 |
weak / 1 |
3 |
4 |
0 |
0 |
moderate / 2 |
0 |
0 |
0 |
0 |
strong / 3 |
0 |
0 |
0 |
0 |
c: control group; t: treatment group; ( ): number of animals
Challenge readings:
24 hours after challenge application, 2/20 animals of the treatment group (10%) and 2/10 animals of the control group (20%) showed slight dermal effects (see Table 3 and Table 4). After 48 hours, 8/20 animals of the treatment group (40%) and 2/10 animals of the control group (20%) showed slight skin reactions. Only for one treated animal (5%) weak skin reactions were observed after 48 hours. After 72 hours no skin reactions were observed in any animal.
Table 3. Summary of positive animals in % after challenge.
Skin reaction/ Value |
control group l / r |
treatment group l / r |
||||
|
24 h |
48 h |
72 h |
24 h |
48 h |
72 h |
slight / 0+ |
20 |
20 |
0 |
10 |
40 |
0 |
weak / 1 |
0 |
0 |
0 |
0 |
5 |
0 |
l: left flank; r: right flank; h: hours
Table 4. Individual gradings for animals of the treatment and the control groups.
Flank Animal number |
1st challenge left right 24 h 48 h 72 h 24 h 48 h 72 h |
|||||
t1 |
0 |
0+ |
0 |
0 |
0+ |
0 |
t2 |
0 |
0+ |
0 |
0 |
0 |
0 |
t3 |
0 |
1 |
0 |
0 |
1 |
0 |
t4 |
0 |
0 |
0 |
0 |
0 |
0 |
t5 |
0 |
0 |
0 |
0 |
0+ |
0 |
t6 |
0 |
0 |
0 |
0 |
0 |
0 |
t7 |
0+ |
0+ |
0 |
0 |
0 |
0 |
t8 |
0 |
0+ |
0 |
0 |
0+ |
0 |
t9 |
0 |
0 |
0 |
0 |
0 |
0 |
t10 |
0 |
0 |
0 |
0 |
0 |
0 |
t11 |
0 |
0 |
0 |
0 |
0 |
0 |
t12 |
0 |
0 |
0 |
0 |
0 |
0 |
t13 |
0 |
0 |
0 |
0 |
0+ |
0 |
t14 |
0+ |
0+ |
0 |
0 |
0+ |
0 |
t15 |
0 |
0 |
0 |
0 |
0+ |
0 |
t16 |
0 |
0 |
0 |
0 |
0 |
0 |
t17 |
0 |
0 |
0 |
0 |
0 |
0 |
t18 |
0 |
0 |
0 |
0 |
0 |
0 |
t19 |
0 |
0 |
0 |
0 |
0 |
0 |
t20 |
0 |
0 |
0 |
0 |
0 |
0 |
c1 |
0 |
0 |
0 |
0 |
0 |
0 |
c2 |
0 |
0 |
0 |
0 |
0 |
0 |
c3 |
0 |
0 |
0 |
0 |
0 |
0 |
c4 |
0 |
0 |
0 |
0 |
0 |
0 |
c5 |
0 |
0 |
0 |
0 |
0 |
0 |
c6 |
0 |
0+ |
0 |
0+ |
0+ |
0 |
c7 |
0 |
0 |
0 |
0 |
0 |
0 |
c8 |
0+ |
0+ |
0 |
0 |
0 |
0 |
c9 |
0 |
0 |
0 |
0 |
0 |
0 |
c10 |
0 |
0 |
0 |
0 |
0 |
0 |
c: control group; t: treatment group; h: hours
grading: none / 0; slight / 0 +; weak / 1
Mortality/Body weight
No mortality was observed during the test period. No significant difference in the gain of the body weight between the treatment and the control group was observed.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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