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Diss Factsheets

Administrative data

Description of key information

Skin sensitisation (OECD 406): not sensitising

RA from source substance (CAS 130905-60-1)

Skin sensitisation (equivalent or similar to OECD 406): not sensitising

RA from source substance (CAS 63705-03-3)

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

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:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
adopted in 1981
Deviations:
yes
Remarks:
no analytical purity reported; no information about positive control
GLP compliance:
yes
Remarks:
Bezirksregierung, Lüneburg, Germany
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
A non-LLNA test is available that was performed prior to the current data requirements, stipulated in Regulation (EC) No 1907/2006. In accordance with the same Regulation, the data was included to avoid unnecessary testing.
Species:
guinea pig
Strain:
other: Pirbright white; Bor: DHPW (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TTEST ANIMALS
- Source: Winkelmann Versuchstierzucht, Borchen, Germany
- Weight at study initiation: 292 – 409 g
- Housing: 5 animals of the same sex per cage in Macrolon cages type IV
- Diet: Ssniff-G (Alleindiät für Meersschweinchen), pellets, ad libitum
- Water: drinking water as for human consumption, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5 ± 3.5
- Humidity (%): 50 – 85
- Photoperiod (hrs dark / hrs light): 12/12

Route:
intradermal and epicutaneous
Vehicle:
other: corn oil/petrolatum
Concentration / amount:
5% (intradermal), 25% (epicuteneous)
Route:
epicutaneous, occlusive
Vehicle:
other: corn oil/petrolatum
Concentration / amount:
25%
No. of animals per dose:
20
Details on study design:
RANGE FINDING TESTS:
Intradermal injection: two animals (one male and one female) were injected 5% test item in diluted in FCA/water. At this concentration no specific skin reaction were found. Therefore 5% was the concentration chosen for the intradermal injection.
Dermal application: Two animals were applied with 25% pasty test article moistened in petrolatum by means of an occlusive dressing. No skin reactions were recorded 48 h post applicationem. Thus, 25% was the concentration chosen for the epicutaneous exposure


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections):
Injection 1: a 1: 1 mixture (v/v) FCA/water
Injection 2: test substance in petrolatum
Injection 3: test substance in a 1:1 mixture (v/v) FCA/water

Epicutaneous: test substance in petrolatum

- Control group:
Intradermal (3 pairs of injections)
Injection 1: a 1:1 mixture (v/V) FCA/water
Injection 2: corn oil/petrolatum
Injection 3: at 50% (w/v) in a 1:1 mixture (v/v) FCA/water

- Site: shoulder region (intradermal + epicutaneous)
- Frequency of applications: every 7 days
- Duration: Days 0-8
- Concentrations: intradermal 5%, epicutaneous 25%

Epicutaneous: petrolatum

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 22
- Exposure period: 24 h
- Test groups: test substance
- Control group: test substance
- Site: left flank (test substance) and right flank (vehicle)
- Concentrations: 25%
- Evaluation (hr after challenge): 48 an 72 h
Positive control substance(s):
no
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
induction: 0%, challenge 25%
No. with + reactions:
0
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
induction: 5%, challenge 25%
No. with + reactions:
0
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Remarks on result:
not measured/tested
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
induction: 5%, challenge 25%
No. with + reactions:
0
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
induction: 5%, challenge 25%
No. with + reactions:
0
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Remarks on result:
not measured/tested
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
Conclusions:
CLP: not classified
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:
guideline study with acceptable restrictions
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:
A non-LLNA test is available that was performed prior to the current data requirements, stipulated in Regulation (EC) No 1907/2006. In accordance with the same Regulation, the data was included to avoid unnecessary testing.
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:
50%
Route:
epicutaneous, occlusive
Vehicle:
other: paraffin perliquid DAB 8 (1. induction and challenge) and vaseline (2. and 3. induction)
Concentration / amount:
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
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50%
No. with + reactions:
5
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Remarks on result:
not measured/tested
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
19
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Remarks on result:
not measured/tested
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
25%
No. with + reactions:
10
Total no. in group:
19
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
25%
No. with + reactions:
5
Total no. in group:
20
Reading:
rechallenge
Hours after challenge:
24
Group:
positive control
Remarks on result:
not measured/tested
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
19
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
20
Reading:
rechallenge
Hours after challenge:
48
Group:
positive control
Remarks on result:
not measured/tested

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.

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
Conclusions:
CLP: 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:
documentation insufficient for assessment
Remarks:
(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:
A non-LLNA test is available that was performed prior to the current data requirements, stipulated in Regulation (EC) No 1907/2006. In accordance with the same Regulation, the data was included to avoid unnecessary testing.
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)
Route:
epicutaneous, occlusive
Vehicle:
other: Paraffinum perliquidum DAB 8, Freund's complete adjuvant (FCA)
Concentration / amount:
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:
induction: 0.1%, challenge: 15%
No. with + reactions:
2
Total no. in group:
19
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
induction: 0.1%, challenge: 15%
No. with + reactions:
10
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Remarks on result:
not measured/tested
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
induction: 0.1%, challenge: 15%
No. with + reactions:
0
Total no. in group:
19
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
induction: 0.1%, challenge: 15%
No. with + reactions:
8
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Remarks on result:
not measured/tested
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
induction: 0.1%, challenge: 10%
No. with + reactions:
0
Total no. in group:
19
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
induction: 0.1%, challenge: 10%
No. with + reactions:
6
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
induction: 0.1%, challenge: 10%
No. with + reactions:
0
Total no. in group:
19
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
induction: 0.1%, challenge: 10%
No. with + reactions:
2
Total no. in group:
20
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
induction: 0.1%, rechallenge: 8%
No. with + reactions:
4
Total no. in group:
19
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
induction: 0.1%, rechallenge: 8%
No. with + reactions:
6
Total no. in group:
20
Reading:
rechallenge
Hours after challenge:
24
Group:
positive control
Remarks on result:
not measured/tested
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
induction: 0.1%, rechallenge: 8%
No. with + reactions:
1
Total no. in group:
19
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
induction: 0.1%, rechallenge: 8%
No. with + reactions:
3
Total no. in group:
20
Reading:
rechallenge
Hours after challenge:
48
Group:
positive control
Remarks on result:
not measured/tested
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
induction: 0.1%, rechallenge: 4%
No. with + reactions:
0
Total no. in group:
19
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
induction: 0.1%, rechallenge: 4%
No. with + reactions:
0
Total no. in group:
20
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
induction: 0.1%, rechallenge: 4%
No. with + reactions:
0
Total no. in group:
19
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
induction: 0.1%, rechallenge: 4%
No. with + reactions:
0
Total no. in group:
20

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.

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 conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Sensitisation

Justification for read-across

There are no data available regarding skin sensitisation for the target substance Fatty acids, C8-10, oxybis(2-hydroxy-3,1-propanediyl) esters (CAS 92044-91-2). Therefore, read across from the relevant source substances Hexanedioic acid, mixed esters with decanoic acid, 12 -hydroxyoctadecanoic acid, isostearic acid, octanoic acid, 3,3'-oxybis[1,2-propanediol] and stearic acid (CAS 130905-60-1) and 1,2,3-Propanetriol, homopolymer, diisooctadecanoate (CAS 63705-03-3) was applied to obtain information regarding sensitising potential towards the skin.

Read-across from appropriate substances is conducted in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5. in order to fulfil the standard data requirements defined in Regulation (EC) No 1907/2006, Annex VIII, 8.3. Structural similarities and similarities in properties and/or activities of the source and target substance are the basis of read-across. A detailed justification for the analogue read-across approach is provided in the technical dossier (see IUCLID Section 13).

 

Skin sensitisation

CAS 130905-60-1

A skin sensitisation study (GPMT) was performed with the test substance according to OECD guideline 406 (Sasol, 1990). 20 Pirbright white guinea pigs were treated for with 5 and 25% test substance for intra- and epidermal induction (48 h), respectively. 20 further animals served as negative control. Epidermal challenge was performed with 25% of the test substance for 24 h. Skin examination revealed no positive skin reactions in any of the animals, neither in the negative control group nor in the test group. No positive control substance was tested.

Based on the available data, the test substance is not regarded as a skin sensitiser.

 

CAS 63705-03-3

A skin sensitisation study (Buehler Test) was performed with the test substance similar to OECD guideline 406 (BASF, 1989). 20 Pirbright white guinea pigs were treated for 6 h with 50% test substance for epidermal induction (occlusive). 19 further animals served as negative control. Epidermal challenge was performed with 50% of the test substance for 6 h and rechallenge with 25% of the test substance. After the first reading (24 h), skin examination revealed 3/19 positive skin reactions in the negative control and 5/20 in the test group. After the second reading (48 h), skin examination revealed no positive skin reactions, neither in the negative control nor in the test group. After the rechallenge (24 h) skin examination revealed 10/19 positive skin reactions in the negative control and 5/20 in the test group. At the second time point of the rechallenge (48 h), skin examination revealed no positive skin reactions, neither in the negative control nor in the test group. As these reactions were only slight reactions (score = 1) and were reversible in all animals within 48 h, they were most probably caused by an irritating rather than a sensitising effect. No data on any positive control substance was provided in the report.

Based on the available data, the test substance is not regarded as a skin sensitiser.

Another skin sensitisation study (GPMT) was performed with this test substance similar to OECD guideline 406 (BASF, 1988). 20 Pirbright white guinea pigs were treated with 0.1 and 40% test substance for intra- and epidermal induction (48 h), respectively. 19 further animals served as negative control. Epidermal challenge was performed with 10 and 15% of the test substance for 24 h and rechallenge with 4 and 8% of the test substance for 24 h. After the first reading after one of the two challenge treatments (24 h, 15%), skin examination revealed positive skin reactions in 2/19 animals of the negative control and in 10/20 animals of the test group. After the second reading (48 h), skin examination revealed positive skin reactions in 0/19 animals of the negative control and in 8/20 animals of the test group. After the first reading of the other challenge treatment (24 h, 10%), skin examination revealed 0/19 positive skin reactions in the negative control and 6/20 in the test group. At the second reading (48 h), skin examination revealed 0/19 positive skin reactions in the negative control and 2/20 positive reactions in the test group. After the first reading of one of the rechallenge treatments (24 h, 8%), skin examination revealed positive skin reactions in 4/19 animals of the negative control and in 6/20 animals of the test group. After the second reading (48 h), skin examination revealed positive skin reactions in 1/19 animals of the negative control and in 3/20 animals of the test group. After the first and second reading of the other rechallenge treatment (24/48 h, 4%), skin examination revealed no positive skin reactions, neither in the negative control nor in the test group. No data on any positive control substance was provided in the report.

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 are inconclusive.

The available data on skin sensitisation after application of the two analogue substances (CAS 130905-60-1 and CAS 63705-03-3) do not meet the criteria for classification according to Regulation (EC) 1272/2008.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the analogue read-across approach, the available data on skin sensitisation do not meet the classification criteria according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.