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EC number: 293-026-9 | CAS number: 91050-80-5
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study with acceptable restrictions (no data on positive control substance or historical controls and lack of data on test substance)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- no data on positive control substance, lack on test substance
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- no data on positive control substance, lack on test substance
- GLP compliance:
- yes
- Type of study:
- Buehler test
Test material
- Reference substance name:
- 63705-03-3
- EC Number:
- 613-333-7
- Cas Number:
- 63705-03-3
- IUPAC Name:
- 63705-03-3
- Details on test material:
- - Name of test material (as cited in study report): Polyglyceryl-3-Diisostearat, Triglycerindiisostearat
- Physical state: liquid
- Appearance: viscous, yellow liquid
- Analytical purity: no data
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright white
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Interfauna, Tuttlingen, Germany (main study) and Winkelmann, Borchen, Germany (pre-study)
- Weight at study initiation: 261.1 - 348.9 g
- Housing: 2 - 3 animals were housed in Makrolon IV cages.
- Diet: Altromin 3032 DK, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 6 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 50 - 60
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: paraffin perliquid DAB 8 (1. induction and challenge) and vaseline (2. and 3. induction)
- Concentration / amount:
- Induction: 50%
Challenge: 50%
Rechallenge: 25%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: paraffin perliquid DAB 8 (1. induction and challenge) and vaseline (2. and 3. induction)
- Concentration / amount:
- Induction: 50%
Challenge: 50%
Rechallenge: 25%
- No. of animals per dose:
- 19 (controls), 20 (in test group)
- Details on study design:
- RANGE FINDING TESTS:
To find an appropriate concentration for induction phase, three guinea pigs were treated on their shaved flanks for 6 h with 5, 10, 15, 30, 40 and 50% of the test substance in paraffin perliquid DAB 8. At the reading time point 24 h thereafter, no skin irritation was observed at any concentration level. To achieve a mild irritation in the induction phase, the animals were pre-treated with 10% sodium dodecylsulfate (SDS) in vaseline 24 h before the induction with 50% of the test substance.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: 0.2 mL test substance in paraffin perliquid DAB 8 (1. induction) or vaseline (2. and 3. induction); 24 h before each induction exposure, all test animals were pre-treated with 10% SDS in vaseline
- Control group: 0.2 mL paraffin perliquid DAB 8 (1. induction) or vaseline (2. and 3. induction); 24 h before induction exposure 1 and 2, the control animals 11-20 were pre-treated with 10% SDS in vaseline; 24 h before induction exposure 3, the control animals 1-10 were pre-treated with 10% SDS in vaseline
- Site: upper right flank
- Frequency of applications: every 7 days for 3 weeks
- Duration: Days 0-70-14
-Concentrations: 50%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 28
- Exposure period: 6 h
- Test groups: 0.1 mL test substance in paraffin perliquid DAB 8
- Control group: 0.1 mL test substance in paraffin perliquid DAB 8
- Site: lower left and right flank
- Concentrations: 50%
- Evaluation (hr after challenge): 24 and 48 h
B. RECHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 35
- Exposure period: 6 h
- Test groups: 0.1 mL test substance in paraffin perliquid DAB 8
- Control group: 0.1 mL test substance in paraffin perliquid DAB 8
- Site: upper left flank
- Concentrations: 25%
- Evaluation (hr after challenge): 24 and 48 h - Challenge controls:
- The control group is actually a challenge control.
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 3
- Total no. in group:
- 19
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 3.0. Total no. in groups: 19.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 5.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 19.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 10
- Total no. in group:
- 19
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 10.0. Total no. in groups: 19.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 5.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 19.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- 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: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Any other information on results incl. tables
Table 1: Results of the challenge treatment with 50% of the test substance
animal |
skin sensitisation (left flank) |
|||||||
test substance group |
negative control group |
|||||||
Erythema |
Edema |
Erythema |
Edema |
|||||
24 h |
48 h |
24 h |
48 h |
24 h |
48 h |
24 h |
48 h |
|
guinea pig 1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
guinea pig 2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
guinea pig 3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
guinea pig 4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
guinea pig 5 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
guinea pig 6 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
guinea pig 7 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
guinea pig 8 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
guinea pig 9 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
guinea pig 10 |
1 |
0 |
0 |
0 |
||||
guinea pig 11 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
guinea pig 12 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
guinea pig 13 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
guinea pig 14 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
guinea pig 15 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
guinea pig 16 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
guinea pig 17 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
guinea pig 18 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
guinea pig 19 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
guinea pig 20 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Table 2: Results of the rechallenge treatment with 25% of the test substance
animal |
skin sensitisation (left flank) |
|||||||
test substance group |
negative control group |
|||||||
Erythema |
Edema |
Erythema |
Edema |
|||||
24 h |
48 h |
24 h |
48 h |
24 h |
48 h |
24 h |
48 h |
|
guinea pig 1 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
guinea pig 2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
guinea pig 3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
guinea pig 4 |
0 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
guinea pig 5 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
guinea pig 6 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
guinea pig 7 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
guinea pig 8 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
guinea pig 9 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
guinea pig 10 |
0 |
0 |
0 |
0 |
||||
guinea pig 11 |
1 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
guinea pig 12 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
guinea pig 13 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
guinea pig 14 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
guinea pig 15 |
0 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
guinea pig 16 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
guinea pig 17 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
guinea pig 18 |
0 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
guinea pig 19 |
0 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
guinea pig 20 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Very slight skin reactions were seen at the first reading in test and control animals and were reversible in all animals within 48 h. These reactions are probably caused by an irritating effect of the test substance.
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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