Registration Dossier

Administrative data

Description of key information

Key (EC 613 -848 -7), Sanders, 2013, not sensitising (LLNA)

Supporting (CAS 68424 -31 -7), Robinson, 1991 (LLNA)

Supporting (EC 234-392-1), Blanset, 1997, not sensitising (Buehler test)

Supporting (CAS 68424-31-7), Lees, 1991, not sensitising (Buehler test)

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2013-06-18 to 2013-07-02
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
Principles of method if other than guideline:
Ear thickness measurements were not taken.
GLP compliance:
yes (incl. certificate)
Type of study:
mouse local lymph node assay (LLNA)
Species:
mouse
Strain:
other: CBA/Ca (CBA/CaOlaHsd)
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxon, UK.
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 15-23 g
- Housing: Animals were individually housed in suspended solid floor polypropylene cages furnished with softwood woodflakes.
- Diet: Food (2014C Teklad Global Rodent diet supplied by Harlan Laboratories UK Ltd., Oxon, UK), ad libitum
- Water: Mains tap water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19-25 °C
- Humidity: 30-70 %
- Air changes: 15 changes per hour
- Photoperiod: 12 h dark / 12 h light

IN-LIFE DATES: From: 2013-06-18 To: 2013-07-02
Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
Preliminary test: 100 %
Main test: 25 and 50 % v/v in acetone/olive oil 4:1 and 100 %
No. of animals per dose:
Preliminary screening test: 1 female/dose
Main test: 4 females/dose
Details on study design:
RANGE FINDING TESTS:
- Compound solubility: Test item was used undiluted and freshly prepared as a solution at the concentrations of 25 and 50 % in acetone/olive oil 4:1
- Irritation: Mouse treated with undiluted test item for three consecutive days (Days 1, 2 and 3) showed no signs of systemic toxicity, visual local skin irritation or irritation indicated by an equal to or greater than 25% increase in mean ear thickness. Based on this information the undiluted test item and the test item at concentrations of 50% or 25% v/v in acetone/olive oil 4:1 were selected for the main test.

MAIN STUDY
- Name of test method: Local Lymph Node Assay
- Criteria used to consider a positive response: The test item will be regarded as a sensitizer if at least one concentration of the test item results in a threefold or greater increase in 3HTdR incorporation compared to control values. Any test item failing to produce a threefold or greater increase in 3HTdR incorporation will be classified as a "non-sensitizer."

TREATMENT PREPARATION AND ADMINISTRATION: The mice were treated by daily application of 25 µL of test material at concentrations of 0 (vehicle control), 25, 50 and 100 % to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3). On Day 6, all mice were injected via the tail vein with 250 μL of phosphate buffered saline (PBS) containing 3H-methyl thymidine (3HTdR: 80 μCi/mL, specific activity 2.0 Ci/mmoL, ARC UK Ltd) giving a total of 20 μCi to each mouse. Five hours following the administration of 3HTdR all mice were killed by carbon dioxide asphyxiation. The draining auricular lymph nodes from the four mice were excised and pooled for each experimental group. For each group 1 mL of PBS was added to the pooled lymph nodes. A single cell suspension of pooled lymph node cells was prepared by gentle mechanical disaggregation through a 200-mesh stainless steel gauze. Lymph node cells were washed with PBS and precipitated with 5 % (w/v) trichloroacetic acid (TCA) for radioactive material at 4 °C. Pellets were re-suspended in 1 mL TCA and transferred to 10 mL of scintillation fluid (Optiphase ‘Trisafe’). 3HTdR incorporation was measured by β -scintillation counting. The proliferation response of lymph node cells was expressed as the number of radioactive disintegrations per minute per lymph node (disintegrations per minute/node) and as the ratio of 3HTdR incorporation into lymph node cells of test nodes relative to that recorded for the control nodes (Stimulation Index).
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Statistics:
No data
Positive control results:
Stimulation index for α-hexylcinnamaldehyde at 25 % v/v in acetone/olive oil 4:1 was 7.33 and classified as a sensitiser.
Parameter:
SI
Remarks on result:
other: Stimulation index for 25, 50 and 100 % were 1.26, 1.28 and 1.48, respectively.
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: DPM per group for vehicle, 25, 50 and 100 % were 8967.55, 11288.98, 11444.45 and 13314.84, respectively. DPM per node for vehicle, 25, 50 and 100 % were 1120.94, 1411.12, 1430.56 and 1664.36, respectively.

Table 7.4.1/1: Results of skin sensitization

Concentration

(% v/v) in

acetone/olive oil 4:1

dpm

dpm/Nodea

Stimulation Indexb

Result

Vehicle

8967.55

1120.94

na

na

25

11288.98

1411.12

1.26

Negative

50

11444.45

1430.56

1.28

Negative

100

13314.84

1664.36

1.48

Negative

dpm = Disintegrations per minute

a= Disintegrations per minute/node obtained by dividing the disintegrations per minute value by 8 (total

number of lymph nodes)

b = Stimulation Index of 3.0 or greater indicates a positive result

na = Not applicable

Clinical observations and mortality data: There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test.

Body Weight: Body weight change of the test animals between Day 1 and Day 6 was comparable to that observed in the corresponding control group animals over the same period.

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under these test conditions,the substance is not classified as sensitizing to the skin according to CLP Regulation (EC) No. 1272/2008
Executive summary:

Test Guidance

OECD Guideline 429 and EC Method B.42 (Skin Sensitisation: Local Lymph Node Assay).

Method and materials

Groups of CBA/Ca (CBA/CaOlaHsd) mice (4 females/dose) were topically applied with 50 µL (25 µL per ear) of the undiluted test item or the test item as a solution in acetone/olive oil 4:1 at concentrations of 50 % or 25 % v/v. A further group of four animals was treated with acetone/olive oil 4:1 alone. On Day 6, the animals received a single intravenous injection of tritiated methyl thymidine (3HTdR). Five hours later, the animals were sacrificed and the auricular lymph nodes were excised. The proliferation of lymphocytes in the lymph node draining the application site was measured by incorporation of 3HTdR. The results were expressed as disintegrations per minute (dpm) per group; dpm/node and the obtained values were used to calculate Stimulation Indices (SI). Animals were observed for mortality, clinical signs and body weight during the study. The test concentrations for the main study were determined from a preliminary study using one female mouse at the concentration of 100 %.

Results

No mortality and no clinical signs were observed during the observation period. Body weight of the animals was unaffected by the test item treatment. DPM per group for vehicle, 25, 50 and 100 % were 8967.55, 11288.98, 11444.45 and 13314.84, respectively. DPM per node for vehicle, 25, 50 and 100 % were 1120.94, 1411.12, 1430.56 and 1664.36, respectively. Stimulation index for 25, 50 and 100 % were 1.26, 1.28 and 1.48, respectively. Positive control (α-hexylcinnamaldehyde, 25%) exhibited evidence of sensitisation indicating the validity of the study. In this study, the substance is not a skin sensitizer in mice.

Conclusion

Under these test conditions, the substance is not classified as sensitising to the skin according to the CLP Regulation (EC)No. 1272/2008).

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
; no information on purity of the test material; both flanks were exposed during challange
GLP compliance:
not specified
Type of study:
Buehler test
Species:
guinea pig
Strain:
other: Albino
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 344-441 g
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
Induction: 100%
Challenge: 30% and 100%
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
Induction: 100%
Challenge: 30% and 100%
No. of animals per dose:
20 (10 for the controls)
Details on study design:
RANGE FINDING TESTS: No Data

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: Undiluted test sample
- Control group: Not stated, but very likely the control group recieved vehicle only.
- Site: scapular region
- Frequency of applications: 7 d interval
- Duration: 14 d
- Concentrations: undiluted

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 28, 14 d after final induction
- Exposure period: 6 h
- Test groups: undiluted (100%) and 30% (w/v in corn oil)
- Control group: undiluted (100%) and 30% (w/v in corn oil)
- Site: undiluted (100%) on left flank and 30% on right flank
- Concentrations: undiluted (100%) and 30% (w/v in corn oil)
- Evaluation (hr after challenge): 24 h and 48 h
Challenge controls:
No
Positive control substance(s):
no
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
30%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
30%
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: 30%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
100%
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: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
Interpretation of results:
not sensitising
Remarks:
Migrated information
Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
yes
Remarks:
No positive control, basic data given
Principles of method if other than guideline:
Local Lymph Node Assay according to Kimber 1989.
GLP compliance:
not specified
Type of study:
mouse local lymph node assay (LLNA)
Species:
mouse
Strain:
other: CBA/Ca
Sex:
female
Vehicle:
other: Acetone
Concentration:
3%, 10% and 30%
No. of animals per dose:
4
Details on study design:
RANGE FINDING TESTS: No Data

MAIN STUDY

- Name of test method: ß-scintillation counting
- Criteria used to consider a positive response:
1. The increase in isotope incorporation for at least one concentration tested must be three-fold or more compared to the control (vehicle treated) mice.
2. The data generated must not be incompatible with the biological dose response.

TREATMENT PREPARATION AND ADMINISTRATION:
Samples were administered to the dorsum of both ears using a micro-pipette.
Groups of 4 female mice were dosed with 25 µl of either vehicle (acetone) or a 30%, 10% or 3% preparation of the test item on three consecutive days on the dorsum of both ears. Five days after initial dosing, the animals received approx. 20 µCi of 3H-methyl thymidine, were sacrificed 5 h later and radioactive counts/lymph node were measured.
Parameter:
SI
Remarks on result:
other: The stimulation index was 0.45 for the 3% application, 2.05 for 10% and 1.21 for the 30% application.
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: No significant increase in isotope incorporation was detected after repeated application. The Cpm (Counts per minute) was 0.0022 Cpm and 0.0047 for the vehicle controls and 0.001, 0.0045 and 0.0057 for 3%, 10% and 30%, respectively.

Test Concentration

Cpm/Lymph Node (x 10-2)

Test/Control Ratio

Vehicle

0.22

-

3% w/v

0.10

0.45

10% w/v

0.45

2.05

Vehicle

0.47

-

30% w/v

0.57

1.21

Interpretation of results:
not sensitising
Remarks:
Migrated information
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
October 08th 1996 - January 21st, 1997
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study Body Weight was evaluated on the day of dosing.
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
Magnussen and Kligmann Method
Deviations:
yes
Remarks:
Bodyweight was evaluated on the day of dosing.
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: HRP inc. and Charles River Laboratories, USA
- Age at study initiation: 5-7 weeks
- Weight at study initiation: Male: 391-489 g; female 366 - 480 g
- Housing: Individually housed in suspended, stainless steel cages with wire mesh bottoms
- Diet (e.g. ad libitum): Agway Prolab Purina Guinea Pig Diet; ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 15 d


ENVIRONMENTAL CONDITIONS
- Temperature and humidity was controlled daily
- Photoperiod (hrs dark / hrs light): 12/12 h

Route:
intradermal and epicutaneous
Vehicle:
propylene glycol
Concentration / amount:
Induction: Intradermal injection 5%, epicutaneous application 100%
Challange: 100%
Route:
epicutaneous, open
Vehicle:
propylene glycol
Concentration / amount:
Induction: Intradermal injection 5%, epicutaneous application 100%
Challange: 100%
No. of animals per dose:
20
Details on study design:
RANGE FINDING TESTS: Yes (Intradermal: October 1st 1996 - October 3rd 1996; Topical: October 1st 1996 - October 4th 1996)
Two animals were pre-treated with two intradermal injections of FCA/water emulsion (1:1) approx. one week prior to test material administration.
Animals were administered 0.1 mL of the test substance (5% w/v) in propylene glycol via injection on either side of the spinal column and observed for dermal irritation 24 h and 48 h after injection.
For the topical range-finding study animals (3 per sex) were dosed with 0.1 mL of four different concentrations (25%, 50%, 75% and 100% in ethyl alcohol) at different sites, two on either side of the column. Treatment was for 24 h under occlusive conditions and observed for dermal irritation 24 h and 48 h afterwards.



MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Test groups: 1
- Control group: 2 (positive and irritation control)
- Site: A row of three injections was made on each side in the shoulder region (Application scheme see Table 1).
- Frequency of applications: Days 1 and 8
- Duration: 25 days
- Concentrations: Intradermal induction: 5%, Topical induction: 100%


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 d after last induction application
- Exposure period: 24 h (Application scheme see Table 1).
- Test groups: 1
- Control group: 2 (positive and irritation control)
- Site: Flank
- Concentrations: 100%
- Evaluation (hr after challenge): 24 and 48 h after removal of the patches
Positive control substance(s):
yes
Remarks:
Hexylcinnamic aldehyde (HCA)
Positive control results:
In the range of the historical controls
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
100%
No. with + reactions:
2
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 100%. No with. + reactions: 2.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
50%
No. with + reactions:
3
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 50%. No with. + reactions: 3.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100%
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 1.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
100%
No. with + reactions:
2
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 100%. No with. + reactions: 2.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
50%
No. with + reactions:
2
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 50%. No with. + reactions: 2.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
100%
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: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Interpretation of results:
not sensitising
Remarks:
Migrated information
Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: analogue substance
Justification for type of information:
Skin sensitisation does not need to be investigated because available data indicate that structural variation does not influence test results or adverse effect profile (see read-across and category justifications attached in Section 13).
Reason / purpose:
read-across source
Parameter:
SI
Remarks on result:
other: Stimulation index for 25, 50 and 100 % were 1.26, 1.28 and 1.48, respectively
Parameter:
other: Disintegrations per minute
Remarks on result:
other: DPM per group for vehicle, 25, 50 and 100 % were 8967.55, 11288.98, 11444.45 and 13314.84, respectively. DPM per node for vehicle, 25, 50 and 100 % were 1120.94, 1411.12, 1430.56 and 1664.36, respectively
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

One reliable study is available. In this study (Sanders, 2013) performed under GLP according to OECD TG 429 and EC Method B.42, groups of CBA/Ca mice (4 females/dose) were topically applied with 50 µL (25 µL per ear) of the undiluted analogue test item (EC 613 -848 -7) or the analogue test item as a solution in acetone/olive oil 4:1 at concentrations of 50 % or 25 % v/v. A further group of four animals was treated with acetone/olive oil 4:1 alone. On Day 6, the animals received a single intravenous injection of tritiated methyl thymidine (3HTdR). Five hours later, the animals were sacrificed and the auricular lymph nodes were excised. The proliferation of lymphocytes in the lymph node draining the application site was measured by incorporation of 3HTdR. The results were expressed as disintegrations per minute (dpm) per group; dpm/node and the obtained values were used to calculate Stimulation Indices (SI). Animals were observed for mortality, clinical signs and body weight during the study. The test concentrations for the main study were determined from a preliminary study using one female mouse at the concentration of 100 %. No mortality and no clinical signs were observed during the observation period. Body weight of the animals was unaffected by the test item treatment. DPM per group for vehicle, 25, 50 and 100 % were 8967.55, 11288.98, 11444.45 and 13314.84, respectively. DPM per node for vehicle, 25, 50 and 100 % were 1120.94, 1411.12, 1430.56 and 1664.36, respectively. Stimulation index for 25, 50 and 100 % were 1.26, 1.28 and 1.48, respectively. Positive control (α-hexylcinnamaldehyde, 25%) exhibited evidence of sensitisation indicating the validity of the study. In this study, the substance is not a skin sensitizer in mice.

Supporting data are also available. Read-across to the toxicological properties of fatty acid polyols (Fatty acids, C5-9, esters with pentaerythritol (EC 270-290-3, CAS 68424-30-6) and Decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate (EC 234-392-1, CAS 11138-60-6)) and their analogues is applicable based on the similarity in structure and physico-chemical properties.

The justification for read-across is presented in Section 13 Assessment reports- Read-across justification.

In a supporting study, a Guinea Pig Maximisation Test of Skin Sensitisation was performed with CAS No. 11138-60-6 (Decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate) according to OECD Guideline 406 (Blanset, 1997). 20 male and female Dunkin-Harley guinea pigs were treated with the test substance and compared with 10 negative control animals. The sensitivity of the animal strain was tested using Hexylcinnamic aldehyde (HCA) as positive control substance. A 5% dilution of the test substance in propylene glycol was used for intradermal induction and 100% used for epidermal induction of the scapular region on days 1 and 8. 14 days after the last induction treatment, all animals were challenged epicutaneously with the undiluted test substance. 24 h after challenge one out of twenty animals showed a skin reaction compared to 2 out of ten for the positive control. 48 hours after challenge exposure all skin examination scores were zero in all test animals.

The skin sensitization potential of the Fatty Acid Polyol with CAS No. 68424-31-7 (Fatty acids, C5-10, esters with pentaerythritol) was evaluated in guinea pigs with a Buehler test for skin sensitisation (Lees, 1991). 20 male albino guinea pigs were treated with the test substance and compared with 10 control animals. Three epidermal inductions were performed with 100 % test substance in weekly intervals for 6 hours under occlusive conditions. 14 days after the last induction treatment, all animals were challenged for 6 hours epicutaneously with 100% (left shorn flank) and 30% (right shorn flank) test substance (diluted in corn oil) under occlusive conditions. Animals were evaluated for skin reactions 24 and 48 h after challenge. No signs for irritation or sensitisation were observed during induction and challenge of the animals.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the results of the mouse local lymph node assay, the substance EC 613 -848 -7 is not classified as sensitising to the skin.