Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Skin sensitisation:

Structure analogue pigment orange 34(nano form): not sensitising (OECD 406, 429)

Structure analogue pigment orange 13 (nano form): not sensitising (OECD 429)

Structure analogue pigment red 38 (nano form): not sensitising (OECD 429)

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:
key study
Study period:
From 20 Aug 1991 to 20 Sep 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD 406), GLP compliant
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
reduced number of animals (sufficient, if unambiguous result)
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The test was performed before the adoption of OECD 429 LLNA in 2002.
Species:
guinea pig
Strain:
other: Pirbright-White
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF Zucht
- Weight at study initiation: 295-352 g
- Housing: groups of 5 animals
- Diet (ad libitum): Altromin §112 Haltungsdiät für Meerschweinchen, Altromin GmbH, Lage/Lippe, Germany
- Water (ad libitum): tap water
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 55 +/- 20
- Photoperiod (hrs dark / hrs light): 12/12

Route:
intradermal and epicutaneous
Vehicle:
petrolatum
Remarks:
for epicutaneous treatment
Concentration / amount:
1% (intradermal induction), 25% (epicutaneous induction), 1% (challenge)
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Remarks:
for epicutaneous treatment
Concentration / amount:
1% (intradermal induction), 25% (epicutaneous induction), 1% (challenge)
No. of animals per dose:
6 for determination of the primary non-irritating concentration
3 for determination of the tolerance of the intradermal injections
10 for treated group
5 for control group
5 for accompanying group

Details on study design:
RANGE FINDING TESTS:
The primary non-irritating concentration was determined in a pre-test in concentrations of 1, 5 and 25% test item in petrolatum, applied to the shaved left flanks of 2 animals each (0,5 g, 2 x 2 cm, occlusive, 24 h). 24 h after removal of the patch the treated areas were examined for erythema and edema.
The tolerance of the intradermal injections was tested with two injections of 0,1 ml of 0.2, 1.0 and 5.0% test item in paraffin. The injection sites (sites 1, 2 and 3) were all within a dorsal area measuring 2 x 4 cm in the vicinity of the shoulders.


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: two intradermal injections per animal, one epicutaneous treatment
- Exposure period: 48 h occlusive for dermal exposure
- Test groups: 10 females
Intradermal Treatment: The injection sites (site 1, 2 and 3) were all within a shaved dorsal area of 2 x 4 cm. The injection sites were left uncovered. Two intradermal injections of 0.1 ml per animal of the following preparations were applied (day 1 of study): site 1: 50% FCA, site 2: 1% test item in paraffin, site 3: test item in 50% FCA
Epicutaneous treatment: An amount of 0.5 g of the test item preparation (25% test substance in petrolatum) was administered to a 2 x 4 cm cellulose patch. This patch covered the area where the intradermal injection had been placed. The administration area was then kept under an occlusive bandage covered with an impermeable film and an elastic bandage for 48 hours.
- Control group and accompanying group: 5 females each
Controls received the same treatment with: intradermal site 1: 50% FCA ( Freund's Complete Adjuvants); site 2: paraffin; site 3: 50% FCA;
epicutaneous: petrolatum
- Site: dorsal, in vicinity of the shoulders
- Frequency of applications: day 1: intradermal treatment, day 8: epicutaneous treament

B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge: day 22 of study
- Exposure period: 24 h, occlusive
- Test groups: An amount of 0.5 g of the test item preparation was administered to a 2 x 2 cm cellulose patch.
- Site: left flank
- Concentrations: 1% in petrolatum (test and control group)
- Evaluation (hr after challenge): 24 and 48 h after removal of the patch

The accompanying group was challenged in the same way as the test group, but on days 15-18 of the study

OTHER:
Evaluation of effects: The decisive criterion for evaluation of the sensitizing properties of a test substance is the number of sensitized test animals, not the intensity of the dermal reaction. The substance is considered to be sensitizing if 30 % or more of the animals in the treatment group definitely showed a positive skin reaction and at the same time no irritant effects have emerged in the control group.
Scoring system for dermal reactions: according to guideline EU B.6 and OECD 406

Positive control substance(s):
not specified
Remarks:
According to guideline, a periodic test with a positive control substance is necessary. These data are not stated in study report, but also not mentioned under "deviations from guidelines"
Positive control results:
not stated
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
1%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no effects
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no effects.
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no effects
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no effects.
Reading:
1st reading
Hours after challenge:
48
Group:
other: accompanying group
Dose level:
1%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no effects
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: other: accompanying group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no effects.
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
1%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no effects
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no effects.
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
1%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no effects
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no effects.
Reading:
2nd reading
Hours after challenge:
72
Group:
other: accompanying group
Dose level:
1%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no effects
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: other: accompanying group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no effects.
Conclusions:
Under the conditions of this guinea pig maximisation test, the test substance was not sensitising.
Executive summary:

Skin sensitization of the test item was performed in 15 female guinea pigs (10 test group, 5 control group) according to the method of Magnusson & Kligman according to guidelines EU B.6 and OECD 406. Intradermal induction was performed with 1% test item in paraffin, dermal induction with 25% test item in petrolatum. The challenge treatment was conducted with 1% test item in petrolatum. Under the conditions of this guinea pig maximisation test, the test substance was not sensitising.

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 6 Nov 2007 to 21 Nov 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD 429), GLP compliant
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)
Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Netherlands, Horst, The Netherlands
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 18.5-21.6 g
- Housing: individually in Macrolon cages
- Diet (ad libitum): pelleted standard diet (Harlan Winkelmann, Borchen, Germany)
- Water (ad libitum): tap water
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
other: ethanol/water (70/30)
Concentration:
0, 5, 10, 20%
No. of animals per dose:
4 females
Details on study design:
RANGE FINDING TESTS:
- Compound solubility: highest technically achievable concentration: 20% solution in ethanol/water (70/30)
- Irritation: 2.5 to 20%, no signs of irritation or systemic toxicity at 20% concentration

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response:
A test item is regarded as a sensitiser in the LLNA if the following criteria are fulfilled:
- First, that exposure to at least one concentration of the test item resulted in an
incorporation of 3HTdR at least 3-fold or greater than that recorded in control mice, as
indicated by the stimulation index.
- Second, that the data are compatible with a conventional dose response, although
allowance must be made (especially at high topical concentrations) for either local
toxicity or immunological suppression.

TREATMENT PREPARATION AND ADMINISTRATION:
Application volume 25 µl, applied on the dorsal surface of each ear lobe, spread over the entire dorals surface, once daily for three consecutive days
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Statistics:
not required
Positive control results:
EC3: 9.9%
Parameter:
SI
Value:
0.92
Test group / Remarks:
5%
Remarks on result:
other: no indication of skin sensitisation based on the in vivo test
Parameter:
SI
Value:
1.59
Test group / Remarks:
10%
Remarks on result:
other: no indication of skin sensitisation based on the in vivo test
Parameter:
SI
Value:
1.54
Test group / Remarks:
20%
Remarks on result:
other: no indication of skin sensitisation based on the in vivo test
Parameter:
other: disintegrations per minute (DPM)
Value:
4 080
Test group / Remarks:
5%
Remarks on result:
other: no indication of skin sensitisation based on the in vivo test
Parameter:
other: disintegrations per minute (DPM)
Value:
7 061
Test group / Remarks:
10%
Remarks on result:
other: no indication of skin sensitisation based on the in vivo test
Parameter:
other: disintegrations per minute (DPM)
Value:
6 821
Test group / Remarks:
15%
Remarks on result:
other: no indication of skin sensitisation based on the in vivo test

 Due to the intense colour of the test item local irritation reactions such as ear redness could not be examined.

 The EC3 value could not be calculated, since all SI were < 3.

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study the test item was not senitising in the LLNA test
Executive summary:

In the study the test item (20% in ethanol/water 70/30) was assessed for its possible contact allergenic potential. For this purpose a local lymph node assay was performed according to guideline OECD 429, using test item concentrations of 5, 10 and 20%. No systemic findings were observed during the study period. Due to the intense colour of the test item local irritation reactions such as ear redness could not be examined. In this study Stimulation Indices (S.I.) of 0.92, 1.59 and 1.54 were determined with the test item at concentrations of 5, 10 and 20% in ethanol/water 70/30, respectively. The test item was not a skin sensitiser in this assay.

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From19 Oct 2005 to 8 Nov 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD 429), GLP compliant
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)
Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Netherlands, Horst, The Netherlands
- Age at study initiation: 6-8 weeks
- Weight prior to treatment: 20.1 +/- 1.2 g (mean +/- SD)
- Housing: individually in Macrolon cages
- Diet (ad libitum): pelleted standard diet (Harlan Winkelmann, Borchen, Germany)
- Water (ad libitum): tap water
- Acclimation period: yes, but duration not stated

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
methyl ethyl ketone
Concentration:
0, 2.5, 5 and 10% in vehicle
No. of animals per dose:
4
Details on study design:
RANGE FINDING TESTS:
To determine the most suitable vehicle a pre-test was performed using the vehicles listed in OECD Guidline 429. Based on the results of this pre-test methyl ethyl ketone was selected as vehicle. To determine the highest non-irritant and technically applicable test item concentration, a pretest was performed in two mice with concentrations of 1.25, 2.5, 5 and 10% in methyl ethyl ketone. The top dose is the highest technically achievable concentration. Due to the intense orange colour of the test item local irritation reactions such as ear redness could not be examined.

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response:
A test item is regarded as a sensitiser in the LLNA if the following criteria are fulfilled:
- First, that exposure to at least one concentration of the test item resulted in an
incorporation of 3HTdR at least 3-fold or greater than that recorded in control mice, as
indicated by the stimulation index.
- Second, that the data are compatible with a conventional dose response, although
allowance must be made (especially at high topical concentrations) for either local
toxicity or immunological suppression.

TREATMENT PREPARATION AND ADMINISTRATION:
Application volume 25 µl, applied on the dorsal surface of each ear lobe, spread over the entire dorals surface, once daily for three consecutive days
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Positive control results:
EC3: 22.2%
Parameter:
SI
Value:
1.12
Test group / Remarks:
2.5%
Remarks on result:
other: no indication of skin sensitisation based on in vivo test
Parameter:
SI
Value:
1.14
Test group / Remarks:
5%
Remarks on result:
other: no indication of skin sensitisation based on in vivo test
Parameter:
SI
Value:
1.33
Test group / Remarks:
10%
Remarks on result:
other: no indication of skin sensitisation based on in vivo test
Parameter:
other: disintegrations per minute (DPM)
Value:
2 750.32
Test group / Remarks:
2.5%
Remarks on result:
other: no indication of skin sensitisation based on in vivo test
Parameter:
other: disintegrations per minute (DPM)
Value:
2 795.81
Test group / Remarks:
5%
Remarks on result:
other: no indication of skin sensitisation based on in vivo test
Parameter:
other: disintegrations per minute (DPM)
Value:
3 267.7
Test group / Remarks:
10%
Remarks on result:
other: no indication of skin sensitisation based on in vivo test

Due to the intense orange colour of the test item local irritation reactions such as ear redness could not be examined.

The EC3 value could not be calculated, since all SI were < 3.

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study the test item was not senitising in the LLNA test
Executive summary:

In the study the test item suspended in methyl ethyl ketone was assessed for its possible contact allergenic potential. For this purpose a local lymph node assay was performed according to guideline OECD 429, using test item concentrations of 2.5, 5 and 10%. No systemic findings were observed during the study period. Due to the intense orange colour of the test item local irritation reactions such as ear redness could not be examined. In this study Stimulation Indices (S.I.) of 1.12, 1.14 and 1.33 were determined with the test item at concentrations of 2.5, 5 and 10% (w/v) in methyl ethyl ketone, respectively. The test item was not a skin sensitiser in this assay.

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 15 Jun 2005 to 21 Jun 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD 429), GLP compliant
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)
Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Netherlands, Horst, The Netherlands
- Age at study initiation: 8-12 weeks
- Weight prior to treatment: 19.6 +/- 1.3 g (mean +/- SD)
- Housing: individually in Macrolon cages
- Diet (ad libitum): pelleted standard diet (Harlan Winkelmann, Borchen, Germany)
- Water (ad libitum): tap water
- Acclimation period: yes, but duration not stated

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-80
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:
dimethyl sulphoxide
Concentration:
0, 6.25, 12.5 and 25% in vehicle (w/v)
No. of animals per dose:
5
Details on study design:
RANGE FINDING TESTS:
- Compound solubility: maximum applicable test concentration: 25%
- Irritation: 3.25 to 25% in DMSO

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response:
A test item is regarded as a sensitiser in the LLNA if the following criteria are fulfilled:
- First, that exposure to at least one concentration of the test item resulted in an
incorporation of 3HTdR at least 3-fold or greater than that recorded in control mice, as
indicated by the stimulation index.
- Second, that the data are compatible with a conventional dose response, although
allowance must be made (especially at high topical concentrations) for either local
toxicity or immunological suppression.

TREATMENT PREPARATION AND ADMINISTRATION:
Application volume 25 µl, applied on the dorsal surface of each ear lobe, spread over the entire dorals surface, once daily for three consecutive days

Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Statistics:
ANOVA (Dunnett-Test)
Positive control results:
EC3: 8.9%
Parameter:
SI
Value:
1.3
Test group / Remarks:
6.25%
Remarks on result:
other: no indication of skin sensitisation based on the assay
Parameter:
SI
Value:
1.7
Test group / Remarks:
12.5%
Remarks on result:
other: no indication of skin sensitisation based on the assay
Parameter:
SI
Value:
2.4
Test group / Remarks:
25%
Remarks on result:
other: no indication of skin sensitisation based on the assay
Parameter:
other: disintegrations per minute (DPM)
Value:
1 015.7
Test group / Remarks:
6.25%
Remarks on result:
other: no indication of skin sensitisation based on the assay
Parameter:
other: disintegrations per minute (DPM)
Value:
1 252.7
Test group / Remarks:
12.5%
Remarks on result:
other: no indication of skin sensitisation based on the assay
Parameter:
other: disintegrations per minute (DPM)
Value:
1 797.1
Test group / Remarks:
25%
Remarks on result:
other: no indication of skin sensitisation based on the assay

Due to the intense red colour of the test item local irritation reactions such as ear redness could not be examined.

The EC3 value could not be calculated, since all SI were < 3.

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study the test item was not senitising in the LLNA test
Executive summary:

In the study the test item suspended in DMSO was assessed for its possible contact allergenic potential. For this purpose a local lymph node assay was performed according to guideline OECD 429, using test item concentrations of 6.25, 12.5 and 25% (w/v). No systemic findings were observed during the study period. Due to the intense red colour of the test item local irritation reactions such as ear redness could not be examined. In this study Stimulation Indices (S.I.) of 1.3, 1.7 and 2.4 were determined with the test item at concentrations of 6.25, 12.5 and 25% in DMSO, respectively. The test item was not a skin sensitiser in this assay.

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
[Please provide information for all of the points below. Indicate if further information is included as attachment to the same record, or elsewhere in the dataset (insert links in 'Cross-reference' table)]

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Please refer to attached read across justification document (Chapter 13).

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Please refer to attached read across document (Chapter 13).

3. ANALOGUE APPROACH JUSTIFICATION
Please refer to attached read across justification document (Chapter 13).

4. DATA MATRIX
Please refer to attached read across justification document (Chapter 13).
Reason / purpose for cross-reference:
read-across source
Positive control results:
EC3: 22.2%
Parameter:
SI
Value:
1.12
Test group / Remarks:
2.5%
Remarks on result:
other: no indication of skin sensitisation based on in vivo test
Parameter:
SI
Value:
1.14
Test group / Remarks:
5%
Remarks on result:
other: no indication of skin sensitisation based on in vivo test
Parameter:
SI
Value:
1.33
Test group / Remarks:
10%
Remarks on result:
other: no indication of skin sensitisation based on in vivo test
Parameter:
other: disintegrations per minute (DPM)
Value:
2 750.32
Test group / Remarks:
2.5%
Remarks on result:
other: no indication of skin sensitisation based on in vivo test
Parameter:
other: disintegrations per minute (DPM)
Value:
2 795.81
Test group / Remarks:
5%
Remarks on result:
other: no indication of skin sensitisation based on in vivo test
Parameter:
other: disintegrations per minute (DPM)
Value:
3 267.7
Test group / Remarks:
10%
Remarks on result:
other: no indication of skin sensitisation based on in vivo test

Due to the intense orange colour of the test item local irritation reactions such as ear redness could not be examined.

The EC3 value could not be calculated, since all SI were < 3.

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study the test item was not senitising in the LLNA test
Executive summary:

In the study the test item suspended in methyl ethyl ketone was assessed for its possible contact allergenic potential. For this purpose a local lymph node assay was performed according to guideline OECD 429, using test item concentrations of 2.5, 5 and 10%. No systemic findings were observed during the study period. Due to the intense orange colour of the test item local irritation reactions such as ear redness could not be examined. In this study Stimulation Indices (S.I.) of 1.12, 1.14 and 1.33 were determined with the test item at concentrations of 2.5, 5 and 10% (w/v) in methyl ethyl ketone, respectively. The test item was not a skin sensitiser in this assay.

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
[Please provide information for all of the points below. Indicate if further information is included as attachment to the same record, or elsewhere in the dataset (insert links in 'Cross-reference' table)]

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Please refer to attached read across justification document (Chapter 13).

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Please refer to attached read across document (Chapter 13).

3. ANALOGUE APPROACH JUSTIFICATION
Please refer to attached read across justification document (Chapter 13).

4. DATA MATRIX
Please refer to attached read across justification document (Chapter 13).
Reason / purpose for cross-reference:
read-across source
Positive control results:
EC3: 8.9%
Parameter:
SI
Value:
1.3
Test group / Remarks:
6.25%
Remarks on result:
other: no indication of skin sensitisation based on the assay
Parameter:
SI
Value:
1.7
Test group / Remarks:
12.5%
Remarks on result:
other: no indication of skin sensitisation based on the assay
Parameter:
SI
Value:
2.4
Test group / Remarks:
25%
Remarks on result:
other: no indication of skin sensitisation based on the assay
Parameter:
other: disintegrations per minute (DPM)
Value:
1 015.7
Test group / Remarks:
6.25%
Remarks on result:
other: no indication of skin sensitisation based on the assay
Parameter:
other: disintegrations per minute (DPM)
Value:
1 252.7
Test group / Remarks:
12.5%
Remarks on result:
other: no indication of skin sensitisation based on the assay
Parameter:
other: disintegrations per minute (DPM)
Value:
1 797.1
Test group / Remarks:
25%
Remarks on result:
other: no indication of skin sensitisation based on the assay

Due to the intense red colour of the test item local irritation reactions such as ear redness could not be examined.

The EC3 value could not be calculated, since all SI were < 3.

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study the test item was not senitising in the LLNA test
Executive summary:

In the study the test item suspended in DMSO was assessed for its possible contact allergenic potential. For this purpose a local lymph node assay was performed according to guideline OECD 429, using test item concentrations of 6.25, 12.5 and 25% (w/v). No systemic findings were observed during the study period. Due to the intense red colour of the test item local irritation reactions such as ear redness could not be examined. In this study Stimulation Indices (S.I.) of 1.3, 1.7 and 2.4 were determined with the test item at concentrations of 6.25, 12.5 and 25% in DMSO, respectively. The test item was not a skin sensitiser in this assay.

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

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

No classification

Testing for sensitizing properties of the registration substance and sturcure analogues was performed according to the method of MAGNUSSON & KLIGMAN and LLNA.The challenge treatment caused no skin reaction.Based on the results of this study the test item showed no evidence for sensitizing properties.