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Administrative data

Description of key information

1. Skin sensitisation: sensitising, Guinea Pig, Open Epicutaneous Test, 1984

2. Skin sensitisation: sensitising, Guinea Pig, Maximisation Test, 1984

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
Study period:
1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Good documented study, although not GLP.
Qualifier:
no guideline available
Principles of method if other than guideline:
By determining carefully all factors favouring contact sensitization and combining them in a single procedure, MAGNUSSON and KLIGMAN (1969, 1970, 1975) developed the so-called Guinea Pig Maximization Test (GMPT).
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The in vivo study (GPMT) was conducted prior to the implementation of the LLNA method
Species:
guinea pig
Strain:
Himalayan
Sex:
male/female
Details on test animals and environmental conditions:
experimental group: 10-20 animals
control or vehicle group: 10-20 animals
primary irritation group: 4 animals
temperature: 22+/- degrees centrigrade
relative humidity: 45 (+/- 10)%
light cycle: 12 hour /day
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
1.0.1 ml FCA alone (adjuvant blended with equal amount of water or saline)
2. 0.1 ml test material in saline
3. 0.1 ml test material in FCA
Day(s)/duration:
DAY 1
Adequacy of induction:
not specified
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
Challenge topical occlusive: 10% and 3%
Day(s)/duration:
28 hours
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: ethanol
Concentration / amount:
10% and 3%
Day(s)/duration:
day 21 to day 23 and 24
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
Experimental group: 10 -20 animals
Control group: 10 - 20 animals
Primary irritation group: 4 animals
Details on study design:
-On day 1 the animals are injected intradermally with :1. 0.1 ml of 5% solution of the compound; 2. with 0.1 ml of FCA alone and 3. with 0.1 ml of a 5% emulsion of the compound in FCA-each injection is given twice;
-On day 8 the compound in petrolatum up to 25% is applied to a clipped skin area of the neck and kept under patch for 2 days.
-On days 21 an occlusive patch test with the compound in ethanol is applied to the flank for 24 hours. the readings done on 24 and 48 hours after removal of the patch.
Challenge controls:
Control group: 10 - 20 animals,
-On day 1 the animals are injected intradermally with :1. vehicle; 2. with 0.1 ml of FCA alone and 3. with 0.1 ml of a 5% emulsion of the compound in FCA-each injection is given twice;
-On day 8 the vehicle is applied to a clipped skin area of the neck and kept under patch for 2 days.
Positive control substance(s):
no
Key result
Reading:
other: Days 23 and 24
Hours after challenge:
24
Group:
test chemical
Dose level:
10%
No. with + reactions:
20
Total no. in group:
20
Clinical observations:
all 20 animals are positive at 10%
Remarks on result:
other: Reading: other: Days 23 and 24. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 20.0. Total no. in groups: 20.0.
Key result
Reading:
other: Days 23 and 24
Hours after challenge:
24
Group:
test chemical
Dose level:
3%
No. with + reactions:
20
Total no. in group:
20
Clinical observations:
20 of 20 animals are positive at 3%
Remarks on result:
other: Reading: other: Days 23 and 24. . Hours after challenge: 24.0. Group: test group. Dose level: 3%. No with. + reactions: 20.0. Total no. in groups: 20.0.
Key result
Reading:
other: Days 23 and 24
Hours after challenge:
24
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
0 out of 20 animals are positive in control group
Remarks on result:
other: Reading: other: Days 23 and 24. . Hours after challenge: 24.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Key result
Reading:
other: Days 23 and 24
Hours after challenge:
24
Group:
positive control
Dose level:
no positive control
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
n/a
Remarks on result:
not measured/tested
Interpretation of results:
Category 1A (indication of significant skin sensitising potential) based on GHS criteria
Conclusions:
Under test conditions safranal induces allergic contact sensitization in all guinea pigs.
Executive summary:

The study was performed using a Guinea Pig Maximization Test method under GLP.

On the day 1 (Induction - Intradermal application), the animals are injected intradermally with :1. 0.1 ml of 5% solution of the compound; 2. with 0.1 ml of FCA alone and 3. with 0.1 ml of a 5% emulsion of the compound in FCA-each injection is given twice.

On the day 8 (Induction - Topical application): the compound in petrolatum up to 25% is applied to a clipped skin area of the neck and kept under patch for 2 days.

On the day 21 (Challenge): an occlusive patch test with the compound in ethanol is applied to the flank for 24 hours. the readings done on 24 and 48 hours after removal of the patch.

Under test conditions used SAFRANAL induces allergic contact sensitization in all guinea pigs. Additionally, performed open epicutaneous tests with 1% and 0.3% alcoholic solution of the preparation 2 weeks after the occlusive challenge elicit allergic reaction in 20/20 animals.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
From February 20, 1984 to April 11, 1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Good documentation, although not a GLP study.
Qualifier:
no guideline available
Principles of method if other than guideline:
CTFA Safety testing guidelines
GLP compliance:
no
Type of study:
open epicutaneous test
Justification for non-LLNA method:
The in vivo study (OET) was conducted prior to the implementation of the LLNA method
Species:
guinea pig
Strain:
Himalayan
Sex:
male/female
Details on test animals and environmental conditions:
Male and female outbred Himalayan white spotted guinea pigs weighing 300 - 450 g, bred at the Institute of Biological Research at Fullinsdorf, Switzerland, are used.
The studies are carried out under standard laboratory conditions. With exception of the treatment periods the animals are caged in wire mesh cages Type 3.
The animal rooms are conditioned:
- Temperature= 22 (+/- 2) degrees centigrade
- Relative humidity= 45 (+/- 10) %
- Light cycle = 12 hours/day
Diet: Pellet standard NAFAG-No. 845 - Ch-9202 Gossau
Water: Tap water ad libitum (water quality according to the requirements of the Schweiz. Lebensmittelbuch).
Route:
epicutaneous, open
Vehicle:
other: ethanol
Concentration / amount:
3, 10, 30, 100 %
Day(s)/duration:
Day 1-28
Adequacy of induction:
other: application of a 10% alcoholic solution SAFRANAL is well tolerated; repeated applications caused slight skin irritation in the 3rd and 4th week of the treatment
No.:
#1
Route:
epicutaneous, open
Vehicle:
other: ethanol
Concentration / amount:
10%
Day(s)/duration:
Day 28
Adequacy of challenge:
highest non-irritant concentration
No.:
#2
Route:
epicutaneous, open
Vehicle:
other: ethanol
Concentration / amount:
10%
Day(s)/duration:
DAY 42
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
Experimental group: 4 x 6 guinea pigs
Controls groups: 10 guinea pigs
Details on study design:
-One day before the induction procedure that threshold toxic of contration is estimated by applying 100, 30, 10 and 3%. The minimal irritating and maximal non-irritating con are determined by an all-or-none criterion.

-Induction, Days 1-21. Day 1 was applied 0.1 ml test materials. The application are repeated daily for 3 weeks or done 5-times weekly for 4 weeks. The application was left uncovered and the reactions can read 24 h after each application.
-Control, 10 untreated or only pretreated with the control.

-Challenge: Days 21-35. Guinea pigs were treated on days 21 and 35 on the contralateral flank with the test material at the minimal irritating and some lower primary nonirritating concentrations. The reactions are read after 24, 48 and/or 72 hours.
Challenge controls:
Challenge control
-Induction: Control, 10 untreated or only pretreated with the control on Day 1-21.
-Challenge: Days 21-35. Guinea pigs were treated on days 21 and 35 on the contralateral flank with the test material at the minimal irritating and some lower primary nonirritating concentrations. The reactions are read after 24, 48 and/or 72 hours.
Positive control substance(s):
no
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
1
Total no. in group:
6
Clinical observations:
n/a
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
30%
No. with + reactions:
4
Total no. in group:
6
Clinical observations:
n/a
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
6
Clinical observations:
n/a
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
3%
No. with + reactions:
0
Total no. in group:
6
Clinical observations:
n/a
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
1
Total no. in group:
6
Clinical observations:
n/a
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
24
Group:
test chemical
Dose level:
30%
No. with + reactions:
5
Total no. in group:
6
Clinical observations:
n/a
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
6
Clinical observations:
n/a
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
24
Group:
test chemical
Dose level:
3%
No. with + reactions:
0
Total no. in group:
6
Clinical observations:
n/a
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
24
Group:
negative control
Dose level:
3, 10, 30 and 100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
n/a
Remarks on result:
no indication of skin sensitisation
Group:
positive control
Remarks on result:
not measured/tested

Skin irritation results:

a) After single application

 Solvent Concentration lowest irritation Concentration highest non irritating ethanol 30%10% 


b) After repeated application of during 28 sucessive days - except week end

 

       Skin irritation after days :

 Concentration% 7 14 21 28 100 strong * strong* strong* strong 30 moderate strong* strong* very strong 10 none none slight slight 3 none none none none


* application sites were changed


Since application of a 10% alcoholic solution SAFRANAL is well tolerated; repeated applications caused slight skin irritation in the 3rd and 4th week of the treatment. Higher concentrated alcoholic solutions cause moderate to very strong skin irritation. Then the application sites had to be changed.


Allergic sensitization:


    Sensitization rate Day 28   Sensitization rate Day 42 After daily application during 4 weeks of Chall Conc% Animals positive/total Chall Conc% Animals positive/total Concentration 100% 10 1/6 101/6  Concentration 30% 10 4/6 10 5/6 Concentration 10% 10 0/6 10 0/6 Concentration 3% 10 0/610  0/6

Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
A weak to moderate sensitizing potential of safranal under the test conditions used
Executive summary:

The study was performed using an Open Epicutaneous Test method. The concentrations selected for the main study were based on the results of a preliminary study.

In the main study, induction was via daily topical application of the test item diluted with ethanol to 0% (control), 3%, 10%, 30%, and 100% for 5 days/week between days 1 -28. A treatment group of 6 per concentration and a control group of 10, respectively were on day 28, challenged with the test material at the minimal irritating and some lower primary nonirritating concentrations. Skin reactions were evaluated 24 to 72 hours after challenge treatment.

Single application of a 10% alcoholic solution of SAFRANAL is well tolerated; repeated applications causes light skin irritation in the 3rd and 4th week of the treatment. Higher concentrated alcoholic solutions cause moderate to very strong skin irritation. Then the application sites had to be changed.

Challenge tests with the highest non irritating alcoholic solution of SAFRANAL elicit allergic reactions in guinea pigs pretreated with the undiluted test material and a 30% solution of the preparation.

A weak to moderate sensitizing potential of SAFRANAL could be found under test conditions used.

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 chemico
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
From February 06, 2019 to March 15, 2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
direct peptide reactivity assay (DPRA)
Details on the study design:
Preparation if test solution: Accurately weighed 150.20 mg of Safranal in 10.0 mL volumetric flask, and dissolved in Acetonitrile : Milli Q water (1:1 v/v) and volume was made up to 10 mL with Acetonitrile: Milli Q water ( 1:1 v/v).
Accurately weighed 150.19 mg of Safranal in 10.0 mL volumetric flask, and dissolved in Acetonitrilc : Milli Q water (1:1 v/v) and volume was made up to 10 mL with Acelonitrile : Milli Q water (1:1 v/v).
Preparation of standard solutions: - Cysteine peptide: 0.669 mM stock solutions of cysteine peptide were prepared by diluting 2.51 mg of cysteine peptide with 5.0 mL of Sodium phosphate buffer of pH 7.5.
- Lysine peptide: 0.668 mM stock solutions of lysine peptide was prepared by diluting 2.59 mg of lysine peptide with 5.0 mL of 100 mM ammonium acetate buffer pH 10.2.

Peptide and test item (1:10 Dilution)
- Cysteine Peptide: a volume of 375µL of cysteine stock solution, 400 µL of phosphate bufler pH 7.5, 25 µLof sample stock solution and 200 µL of acetonitrile were added to HPLC vial.
- Lysine Peptide: a volume of 375µL of lysine stock solution, 400 µL of ammonium acetate bufler pH 10.2, 25 µLof sample stock solution and 200 µL of acetonitrile were added to HPLC vial.
Peptide and test item (1:50 Dilution)
- Cysteine Peptide: a volume of 375µL of cysteine stock solution, 300 µL of phosphate bufler pH 7.5, 125 µLof sample stock solution and 200 µL of acetonitrile were added to HPLC vial.
- Lysine Peptide: a volume of 375µL of lysine stock solution, 300 µL of ammonium acetate bufler pH 10.2, 125 µLof sample stock solution and 200 µL of acetonitrile were added to HPLC vial.
HPLC vials were gently vortexed and incubated for 24 hours at 25°C ± 2.5°C in the (dark) prior to HPLC analysis. Preparation was done in triplicates and single HPLC run was performed for each preparation.

Preparation of Control: A volume of 375 µL of cysteine stock solution, 425 µL phosphate buffer pH 7.5 and 200 µL of acetonitrile were added to HPLC vial.
A volume of 375 µL of lysine stock solution, 425 µL ammonium acetate buffer pH 10.2 and 200 µL of acetonitrile were added lo HPLC vial.
HPLC vials will be gently vortexed and incubated for 24 hours at 25°C ± 2.5°C in the dark place prior to HPLC analysis. Preparation was done in triplicates and single HPLC run will be performed for each preparation.

Prepation of Linearity Standards for Cysteine Peptide:
• A volume of 25 µL of cysteine stock solution, 925 µL phosphate buffer pH 7.5 and 50 µL of acetonitrile were added to HPLC vial (0.0167 mM).
• A volume of 50 µL of cysteine stock solution, 900 µL phosphate buffer pH 7.5 and 50 µL of acetonitrile were added to HPLC vial (0.0334 mM).
• A volume of 100 µL of cysteine stock solution, 850 µL phosphate buffer pH 7.5 and 50 µL of acetonitrile were added to HPLC via l (0.0669 mM).
• A volume of 200 µL of cysteine stock solution, 750 µL phosphate buffer pH 7.5 and 50 µL of acetonitrile were added to HPLC vial (0. 1337 mM).
• A volume of 200 µL of cysteine stock solution, 275 µL phosphate buffer pH 7.5 and 25 µL of acetonitrile were added to HPLC vial (0.2674mM).
• A volume of 400 µL of cysleine stock solution, 75 µL phosphate buffer pH 7.5 and 25 µL of acetonitrile were added to HPLC vial (0.5348 mM).
Each standard was injected and a linearity curve was prepared using regression analysis.The correlation coefficient, slope and intercept were calculated.

Prepara tion or Linearity Standard for Lysine Peptide
• A volume of 25 µL of lysine stock solution, 925 µL ammonium acetate buff'er pH 10.2 and 50 µL of acetonitrile were added to HPLC vial (0.0 167 mM).
• A volume of 50 µL of lysine slock solution, 900 µL ammonium acetate buffer pH 10.2 and 50 µL of acetonitrile were added to HPLC vial (0.0334mM).
• A volume of 100 µL of lysine stock solution, 850 µL ammonium acetate buffer pH 10. 2 and 50 µL of acetonitrile were added to HPLC vial (0.0668 mM).
• A volume of 200 µL of lysine stock solution, 750 µL ammonium acetate buffer pH 10.2 and 50µL of acetonitrie were added to HPLC vial (0.1355 mM).
• A volume of 200 µL of lysine stock solution, 275 µL ammonium acetate buffer pH 10.2 and 25 µL of acetonitrile were added to HPLC vial (0.2670 mM).
• A volume of 400 µL of lysine stock solution, 50 µL ammonium acetate buffer pH 10.2 and 25 µL of acetonitrile were added to HPLC vial (0.5341 mM ).
Each standar was injected and a linearity curve was prepared using regression analysis. The correlation coefficient, slope and intercept were calculated.

Analysis: All prepared samples were loaded to HPLC sequence and chromatograms were determined at 220 run. Peptide reactivity with the test item was reported as percent peptide depletion, which was determined as the reductionof the peptide concentration in the samples relative to the average concentration of the controls.
Key result
Run / experiment:
other: Cysteine (1:10)
Parameter:
other: Mean of Cysteine depletion
Value:
90.63
Vehicle controls validity:
not examined
Negative controls validity:
not examined
Positive controls validity:
valid
Remarks on result:
positive indication of skin sensitisation
Key result
Run / experiment:
other: Lysine (1:50)
Parameter:
other: Mean of Lysine depletion
Value:
20.81
Vehicle controls validity:
not examined
Negative controls validity:
not examined
Positive controls validity:
valid
Remarks on result:
positive indication of skin sensitisation
Other effects / acceptance of results:
The mean value of the percent cysteine and lysine depletion was calculated for the test item. From the mean value of the percent cysteine and lysine depletion, the reactivity class was classified and the skin sensitivity was predicted.

Evaluation Method:

Mean of Cysteine and Lysine depletion Reactivity Class Prediction
0% < Mean % Depletion < 6.38% Minimal Reactivity Non- Sensitiser Negative
6.38% < Mean % Depletion < 22.62% Low Reactivity Sensitiser Positive
22.62% < Mean % Depletion < 42.47% Moderate Reactivity Sensitiser
42.47%< Mean % Deplet ion < 100 % High Reactivity Sensitiser

Results:

Particulars Sample Code Sample Peak Area (mAU) Mean Sample Peak Area (mAU) Percent Peptide Depletion Mean Percent Peptide Depletion
Cysteine (1:10) Control R1 1144.19 12 16.98 - -
Control R2 1260.77
Control R3 1245.99
Sample Rl 119.62 - 90.17 90.63
Sample R2 108.2 2 91.11
Sample R3 I14.21 90.62
Lysine (1:50) Control R1 680.48 704.435 - -
Control R2 724.98
Control R3 707.85
Sample RI 544.9 - 22.65 20.81
Sample R2 553.78 21.39
Sample R3 574.76 18.41

Average Percent Depiction

 55.72

Prediction

 High Reactivitv
Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
The percent peptide depletion was 90.63% for cysteine peptide solution and 20.81% for lysine peptide solution. The mean value of the percent cysteine ad lysine depletion was 55.72%. Therefore, the reactivity class of test item was classified to " High Reactivity Sensitizer" and skin sensitivity was predicted as " Positive" in these testing conditions.
Executive summary:

The objective of the study was to screen the test item Safranal for skin sensitizing potential by direct peptide reactivity assay (DPRA).

The test item dissolved in acetonitrile was mixed with cysteine peptide solution (1:10) and lysine peptide solution (1:50) respectively, was incubated at25±2.5°C for 24 hours. After 24hours of incubation the reaction solutions were analysed by high performance liquid chromatography and peak area for each peptide was determined. Percent cysteine and percent lysine peptide depletion, and the average value of the percent peptide depletions were calculated.

Consequently, the percent peptide depletion was 90.63% for cysteine peptide solution (1:10) and 20.81% for lysine peptide solution (1:50). The mean value of the percent cysteine and lysine depletion was 55.72%.Therefore,the reactivity class of test item was classified to" High Reactivity sensitizer"and skin sensitivity was predicted as "Positive".

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Two old in vivo studies but well documented studies indicating sensitisation.

Weight of Evidence : in vivo, Open Epicutaneous Test (OET), 1984 : The concentrations selected for the main study were based on the results of a preliminary study. In the main study, induction was via daily topical application of the test item diluted with ethanol to 0% (control), 3%, 10%, 30%, and 100% for 5 days/week between days 1 -28. A treatment group of 6 per concentration and a control group of 10, respectively were on day 28, challenged with the test material at the minimal irritating and some lower primary nonirritating concentrations. Skin reactions were evaluated 24 to 72 hours after challenge treatment. Single application of a 10% alcoholic solution of SAFRANAL is well tolerated; repeated applications causes light skin irritation in the 3rd and 4th week of the treatment. Higher concentrated alcoholic solutions cause moderate to very strong skin irritation. Then the application sites had to be changed. Challenge tests with the highest non irritating alcoholic solution of SAFRANAL elicit allergic reactions in guinea pigs pretreated with the undiluted test material and a 30% solution of the preparation.

A weak to moderate sensitizing potential of SAFRANAL could be found under test conditions used.

Weight of Evidence: The study was performed using a Guinea Pig Maximization Test method under GLP

On the day 1 (Induction - Intradermal application), the animals are injected intradermally with :1. 0.1 ml of 5% solution of the compound; 2. with 0.1 ml of FCA alone and 3. with 0.1 ml of a 5% emulsion of the compound in FCA-each injection is given twice.

On the day 8 (Induction - Topical application): the compound in petrolatum up to 25% is applied to a clipped skin area of the neck and kept under patch for 2 days.

On the day 21 (Challenge): an occlusive patch test with the compound in ethanol is applied to the flank for 24 hours. the readings done on 24 and 48 hours after removal of the patch.

Under test conditions used SAFRANAL induces allergic contact sensitization in all guinea pigs. Additionally, performed open epicutaneous tests with 1% and 0.3% alcoholic solution of the preparation 2 weeks after the occlusive challenge elicit allergic reaction in 20/20 animals.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Self-classification:

Based on the available information, the substance meets classification criteria under Regulation (EC) No. 1272/2008 (CLP) and to the GHS for skin sensitisation category 1A.