Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Description of key information
skin sensitisation, rabbit (OECD 406, GPMT): not sensitising
Read across from the source substance 1,2,3 -propanetriol, homopolymer, diisooctadecanoate (CAS 63705-03-3).
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- 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)
- 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
- Justification for non-LLNA method:
- The test was performed in 1989 when the OECD Guideline 406 was the current test guideline. According to this guideline "the Guinea Pig Maximisation Test (GPMT) [...] and the non-adjuvant Buehler Test are given preference over other methods.“
- 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 - 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% - 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
- 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.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- see below
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Remarks on result:
- other:
- Remarks:
- No postiive control was inlcuded in the study
- Interpretation of results:
- not sensitising
- Conclusions:
- CLP: not classified
DSD: not classified - Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Documentation is insufficient for assessment (no data on positive control substance or historical controls and lack of data on test substance)
- Principles of method if other than guideline:
- The sensitisation potential of the test substance was assessed by conducting a Guinea pig maximisation test.
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The test was performed in 1989 when the OECD Guideline 406 was the current test guideline. According to this guideline "the Guinea Pig Maximisation Test (GPMT) [...] and the non-adjuvant Buehler Test are given preference over other methods.“
- Species:
- guinea pig
- Strain:
- other: Pirbright white
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Interfauna, Tuttlingen, Germany
- Weight at study initiation: 314.5 - 410.4 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 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 50 - 60
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal and epicutaneous
- Vehicle:
- other: Paraffinum perliquidum DAB 8, Freund's complete adjuvant (FCA)
- Concentration / amount:
- Induction: 0.1% (intradermal) and 40% (epicutaneous)
Challenge: 10 and 15%
Rechallenge: 8 and 4% - Route:
- epicutaneous, occlusive
- Vehicle:
- other: Paraffinum perliquidum DAB 8, Freund's complete adjuvant (FCA)
- Concentration / amount:
- Induction: 0.1% (intradermal) and 40% (epicutaneous)
Challenge: 10 and 15%
Rechallenge: 8 and 4% - No. of animals per dose:
- 19 (controls), 20 (in test group)
- Details on study design:
- RANGE FINDING TESTS:
To find an appropriate concentration for intradermal induction, three guinea pigs were treated with 0.1, 0.5, 1.0 and 2.0% of the test substance in Paraffinum perliquidum DAB 8. An adequate irritation was achieved by a concentration of 0.1% test substance. Three other guinea pigs were epicutaneously treated on one flank with 5, 10 and 15% of the test substance in Paraffinum perliquidum DAB 8 to provoke a slight irritative effect. Because no irritation was observed at any concentration level, the animals were treated one week later on the other flank with 15 and 30% test substance in vaseline and 30% test substance in Paraffinum perliquidum DAB 8. A slight irritation was observed. For the main study, 40% of the test substance was used.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 intradermal injections and one epicutaneous treatment, respectively
- Exposure period: single injections (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections)
Injection 1: 0.1 mL of a 1:1 mixture (v/v) FCA/physiological saline (0.9 % NaCl in water)
Injection 2: 0.1 mL of 0.1% test substance in Paraffinum perliquidum DAB 8
Injection 3: 0.1 mL of a 1:1 mixture (v/v)of 0.2% test substance in Paraffinum perliquidum DAB 8 and 50% FCA in physiological saline
Epicutaneous: 1 mL of 40% test substance in Paraffinum perliquidum DAB 8
- Control group:
Intradermal (3 pairs of injections)
Injection 1: 0.1 mL of a 1:1 mixture (v/v) FCA/physiological saline (0.9 % NaCl in water)
Injection 2: 0.1 mL of Paraffinum perliquidum DAB 8
Injection 3: 0.1 mL of a 1:1 mixture (v/v)of Paraffinum perliquidum DAB 8 and FCA and 50% FCA in physiological saline
Epicutaneous: 1 mL Paraffinum perliquidum DAB 8
- Site: shoulder region (intradermal and epicutaneous)
- Frequency of applications: intradermal injection on Day 1 and epicutaneous application on Day 8
- Duration: single intradermal injections; epicutaneous treatment for 48 h
- Concentrations: intradermal 0.1%, epicutaneous 40%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: Day 22
- Exposure period: 24 h
- Test groups: 0.1 mL of the test substance in Paraffinum perliquidum DAB 8
- Control group: 0.1 mL of the test substance in Paraffinum perliquidum DAB 8
- Site: right flank
- Concentrations: 10 and 15% in parallel
- Evaluation (hr after challenge): 24 and 48 h
C. RECHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: Day 29
- Exposure period: 24 h
- Test groups: 0.1 mL of the test substance in Paraffinum perliquidum DAB 8
- Control group: 0.1 mL of the test substance in Paraffinum perliquidum DAB 8
- Site: left flank
- Concentrations: 4 and 8% in parallel
- Evaluation (hr after challenge): 24 and 48 h - Challenge controls:
- The control group is actually a challenge control.
- Positive control substance(s):
- not specified
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.1%
- No. with + reactions:
- 2
- Total no. in group:
- 19
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.1%. No with. + reactions: 2.0. Total no. in groups: 19.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 10
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1%. No with. + reactions: 10.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.1%
- No. with + reactions:
- 1
- Total no. in group:
- 19
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.1%. No with. + reactions: 1.0. Total no. in groups: 19.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.1%. No with. + reactions: 8.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.1%. No with. + reactions: 0.0. Total no. in groups: 19.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1%. No with. + reactions: 6.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.1%
- 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: 0.1%. No with. + reactions: 0.0. Total no. in groups: 19.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.1%. No with. + reactions: 2.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.1%
- No. with + reactions:
- 4
- Total no. in group:
- 19
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.1%. No with. + reactions: 4.0. Total no. in groups: 19.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1%. No with. + reactions: 6.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.1%
- No. with + reactions:
- 1
- Total no. in group:
- 19
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.1%. No with. + reactions: 1.0. Total no. in groups: 19.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 0.1%. No with. + reactions: 3.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.1%. No with. + reactions: 0.0. Total no. in groups: 19.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1%
- 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: 0.1%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.1%
- 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: 0.1%. No with. + reactions: 0.0. Total no. in groups: 19.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1%
- 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: 0.1%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- see below
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Remarks on result:
- other:
- Remarks:
- No postiive control was inlcuded in the study
- Interpretation of results:
- other: inconclusive
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- With regard to the results of the challenge with 10 and 15% of the test substance, the conclusion could be drawn, that the test substance has a skin sensitizing potential. The results of the rechallenge with 4 and 8% of the test substance, however, might indicate that the skin reactions were caused by an irritative effect of the test substance.
Due to the fact that a high concentration of 40% for the epicutaneous induction was required to induce a slight to moderate irritation, it has to be concluded that the low concentrations of the rechallenge were not sufficient to penetrate the intact skin. Therefore, the results of the rechallenge are of minor importance.
Taken together, the results of this study report were judged as ambigious. - Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Remarks:
- Summary of available data used for the endpoint assesssment of the target substance
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- refer to the analogue justification provided in IUCLID section 13
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Key result
- 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.
- Remarks:
- Source CAS 63705-03-3 (Buehler test)
- Key result
- 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.
- Remarks:
- Source CAS 63705-03-3 (Buehler test)
- Key result
- 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.
- Remarks:
- Source CAS 63705-03-3 (Buehler test)
- Key result
- 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.
- Remarks:
- Source CAS 63705-03-3 (Buehler test)
- Key result
- 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.
- Remarks:
- Source CAS 63705-03-3 (Buehler test)
- Key result
- 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.
- Remarks:
- Source CAS 63705-03-3 (Buehler test)
- Key result
- 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.
- Remarks:
- Source CAS 63705-03-3 (Buehler test)
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- see below
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Remarks on result:
- other:
- Remarks:
- No postiive control was inlcuded in the study
- Interpretation of results:
- not sensitising
- Conclusions:
- As detailed in the analogue justification, it is considered that the target and the source substances are unlikely to lead to differences in skin sensitisation potential. The available data on suitable source substances did not show any skin sensitising effects. Therefore, the target substance is not predicted to be a skin sensitiser.
Referenceopen allclose all
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.
Table 1: Results of the challenge treatment with 15% of the test substance
animal |
skin sensitisation (right flank) |
|||||||
challenge dose: 15% test substance |
||||||||
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 |
1 |
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 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
guinea pig 6 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
guinea pig 7 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
guinea pig 8 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
guinea pig 9 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
guinea pig 10 |
1 |
1 |
1 |
0 |
|
|||
guinea pig 11 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
guinea pig 12 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
guinea pig 13 |
0 |
2 |
2 |
2 |
0 |
0 |
0 |
0 |
guinea pig 14 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
guinea pig 15 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
guinea pig 16 |
0 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
guinea pig 17 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
guinea pig 18 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
guinea pig 19 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
guinea pig 20 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Table 2: Results of the challenge treatment with 10% of the test substance
animal |
skin sensitisation (right flank) |
|||||||
challenge dose: 10% test substance |
||||||||
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 |
1 |
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 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
guinea pig 9 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
guinea pig 10 |
0 |
0 |
0 |
0 |
|
|||
guinea pig 11 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
guinea pig 12 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
guinea pig 13 |
3 |
3 |
3 |
3 |
0 |
0 |
0 |
0 |
guinea pig 14 |
1 |
1 |
2 |
1 |
0 |
0 |
0 |
0 |
guinea pig 15 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
guinea pig 16 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
guinea pig 17 |
0 |
0 |
0 |
0 |
0 |
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 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Table 3: Results of the rechallenge treatment with 8% of the test substance
animal |
skin sensitisation (left flank) |
|||||||
rechallenge dose: 8% test substance |
||||||||
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 |
1 |
0 |
0 |
0 |
guinea pig 5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
guinea pig 6 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
guinea pig 7 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
guinea pig 8 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
guinea pig 9 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
guinea pig 10 |
0 |
0 |
0 |
0 |
|
|||
guinea pig 11 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
guinea pig 12 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
guinea pig 13 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
guinea pig 14 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
guinea pig 15 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
guinea pig 16 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
guinea pig 17 |
1 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
guinea pig 18 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
guinea pig 19 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
guinea pig 20 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
Results of the rechallenge treatment with 4% of the test substance
The rechallenge treatment on the left flank with 4% of the test substance did neither in the test substance group nor in the negative control group result in any erythema or edema at the 24 and 48 h reading time points.
Results of the induction phase
The intradermal injections of 0.1 mL of FCA (50% (v/v)), the test substance (0.1% (v/v)) and a 1:1 mixture of the test substance with FCA caused moderate to severe skin reactions. In the control group, the intradermal injection of 0.1 mL of the vehicle leads to moderate skin reactions. After the epicutaneous treatment of the test group with 40% of the test substance, the injection sites of the intradermal induction were bloody and purulent and at a later stage, this sites showed necrotic and scabby skin lesions.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
There are no skin sensitisation data available with Fatty acids, C16-18 (even numbered), esters with glycerol oligomers. A skin sensitisation study with the registered substance has been commissioned at a CRO. Therefore, as an interim measure, the skin sensitisation potential of the registered substance was assessed based on the available data from the source substances 1,2,3 -propanetriol, homopolymer, diisooctadecanoate (CAS 63705-03-3). In accordance with Regulation (EC) No. 1907/2006 Annex XI, 1.5 “Grouping of substances and read across” and following the Read across assessment framework (RAAF, ECHA 2017) read across from an analogue substance has been applied to support the human health hazard assessment of Fatty acids, C16-18 (even numbered), esters with glycerol oligomers.
Two studies investigating the skin sensitising potential of 1,2,3 -propanetriol, homopolymer, diisooctadecanoate (CAS 63705-03-3) are available.
A study was performed according to a Buehler test protocol similar to OECD Guideline 406 in Pirbright white guinea pigs and under GLP conditions (Kaestner, 1989). The test material was diluted in paraffin perliquid DAB 8 (1st Induction and challenge) or vaseline (2nd and 3rd induction) and applied at a concentration of 50% for epidermal induction and challenge and at concentration of 25% for rechallenge. The negative control group was treated with the vehicle only. No positive control data was included in the study report for reliability check.
The test animals were treated with the product on the right body side three times in intervals time of one week each. The substance was applied at a concentration of 50% under occlusive conditions for 6 hours every time on the same skin areas. The control group was treated with vehicle only.
14 days later the test and control animals were treated on the right and left body side with the test substance at a concentration of 50% with patches for 6 h (challenge).
One week later the rechallenge treatment was conducted on test and control animals and the test substance was applied the left body side with a 25% solution. After challenge and rechallenge at patch removal, very slight skin reactions were seen at the first reading (24 h after challenge) in test and control animals and were reversible in all animals within 48 h. These reactions were probably caused by an irritating effect of the test substance. These reactions were nearly the same on both groups. At the second reading after challenge (48 h) and rechallenge no effects in terms of skin reactions were observed in both groups. According to these results the test substance is not a skin sensitiser.
A not sufficiently documented (no data on positive control substance or historical controls and lack of data on test substance) guinea pig maximisation test was performed to assess the skin sensitisation potential of 1,2,3 -propanetriol, homopolymer, diisooctadecanoate (CAS 63705-03-3), (Kästner, 1988). 20 female Pirbright-Hartley guinea pigs were treated with the test substance at 0.1% for intra- and 40 % for epidermal induction on Days 1 and 8, respectively. 19 animals served as negative controls. A positive control group was not included in the study and no information is given on periodical testing of strain sensitivity, either. 14 days after the epidermal induction, epidermal challenging was performed with a 10% and 15% test material dilution in Paraffinum perliquidum DAB 8.
24 and 48 h after challenging skin examination revealed irritation in the test group and in the control group. Rechallenge treatment (conducted on the left flank 7 days after challenge) with 8% test substance showed irritation in the test group and in the control group, while the rechallenge with 4% of the test substance did neither in the test substance group nor in the negative control group result in any erythema or edema at the 24 and 48 h reading time points.
With regard to the results of the challenge with 10 and 15% of the test substance, the conclusion could be drawn, that the test substance has a skin sensitizing potential. The results of the rechallenge with 4 and 8% of the test substance, however, might indicate that the skin reactions were caused by an irritative effect of the test substance.
Due to the fact that a high concentration of 40% for the epicutaneous induction was required to induce a slight to moderate irritation, it has to be concluded that the low concentrations of the rechallenge were not sufficient to penetrate the intact skin. Therefore, the results of the rechallenge are of minor importance.
Taken together, the results of this study report were judged as ambiguous.
Conclusion for skin sensitisation properties
Taken together, all available data for assessment of the skin sensitising potential indicate that the source substance 1,2,3 -propanetriol, homopolymer, diisooctadecanoate (CAS 63705-03-3) has no skin sensitisation potential. Thus and based on read-across, the registration substance can also be concluded as not being a skin sensitiser.
Justification for classification or non-classification
Based on read-across from a structurally similar substance, the available data on skin sensitisation do not meet the criteria for classification according to Regulation (EC) No. 1272/2008, and are therefore conclusive but not sufficient for classification.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
