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Diss Factsheets

Administrative data

Description of key information

Skin sensitisation:


Structure analogue pigment red 122 (nano form): not sensitising (OECD 406)


Structure analogue pigment violet 19 (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 vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 2 NOV 2004 to 24 NOV 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline Study (OECD TG 429)
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
according to German Chemical Law and OECD Principles of GLP
Type of study:
mouse local lymph node assay (LLNA)
Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- strain: CBA/CaOlaHsd
- Source: Harlan Netherlands
- Age at study initiation: 8-12 weeks (beginning of acclimatization)
- Weight at study initiation: mean: 18.9 +/- 2.0 g
- Housing: individually, Makrolon Type I cages
- Diet: pelleted standard diet (Harlan Winkelmann, Borchen), ad libitum
- Water: tap water, ad libitum
- Acclimatization: yes (acclimatization period not given)


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-3
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12 hrs/12 hrs
Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
5, 10, 20 % (w/v)
No. of animals per dose:
4 females
Details on study design:
RANGE FINDING TESTS:
- non GLP
- Compound solubility: 10% (w/v) suspension in acetone:olive oil (4:1 v/v) was the highest technically applicable concentration; higher concentrations could also not be achieved with other vehicles
- Irritation: irritation effects could not be determined due to the intense red colour of the test item. No ear swelling was observed at these concentrations after a single application
- Lymph node proliferation response: no data


MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response:
1: exposure to at least one concentration of the test item resulted in an incorporation of 3H-methyl thymidine at least 3-fold or greater than that recorded in control mice as indicated by the stimulation index
2: data are compatible with a conventional dose response, although allowance must be made for either local toxicity or immunological suppression


TREATMENT PREPARATION AND ADMINISTRATION:
- individual preparation of weight volume dilutions using a magnetic stirrer as homogenizer
- test item preparations were made freshly before each dosing occasion
- the application volume of 25 µl was spread over the entire dorsal surface of each ear lobe once daily for three consecutive days
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Statistics:
- calculation of mean values and standard deviations for body weight
- statistical evaluation of the dose-response relationship
Positive control results:
Stimulation indices of 2.0, 3.0 and 4.9 were determined in a separate test with the positive control substance at concentrations of 5%, 10% and 25% (w/v), respectively, in acetone:olive oil. An EC3 value of 9.9% (w/v) was calculated.

Key result
Parameter:
SI
Value:
1.6
Test group / Remarks:
20%
Remarks on result:
other: 5%: 2.110%: 1.820%: 1.6
Key result
Parameter:
SI
Value:
1.8
Test group / Remarks:
10%
Remarks on result:
other: 5%: 2.110%: 1.820%: 1.6
Key result
Parameter:
SI
Value:
2.1
Test group / Remarks:
5%
Remarks on result:
other: 5%: 2.1 10%: 1.8 20%: 1.6
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: Background: 0; 4.7 (duplicate) Control: 2584.5 (2.582.2 without background) 5%: 5397.8 (5395.5 without background) 10%: 4542.4 (4540.1 without background) 20%: 4183.7 (4184.4 without background)

No deaths occurred during the study period.

The body weight of the animals, recorded prior to the 1stapplication and prior to necropsy,

was within the range commonly recorded for animals of this strain and age.

No symptoms of local toxicity at the ears of the animals and no systemic findings were observed during the study period. Due to the colour of the test item, a redness of the ears could not be analysed. However, no signs of ear swelling occurred.  

Calculation of the EC3 value was not performed, because no test concentration produced a SI of 3 or higher.

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Under the conditions of this LLNA-assay, the test substance was not sensitising.
Executive summary:

In the study the test item dissolved in acetone:olive oil, 4:1 (v/v) was assessed for its possible contact allergenic potential. For this purpose a local lymph node assay was performed in CBA mice (4 females per group) using test item concentrations of 5, 10 and 20% (w/v). The animals did not show any clinical signs during the course of the study and no cases of mortality were observed. In this study stimulation indices (S.I.) of 2.1, 1.8 and 1.6 were determined with the test item at concentrations of 5, 10 and 20% (w/v) in acetone:olive oil, 4:1 (v/v), respectively. A EC3 value could not be determined. The test item was not a skin sensitiser under the conditions tested. The positive control substance was sensitising (EC value 9.9%), thus confirming the validity of the tests system.

Therefore, the test item has not to be classified as skin sensitiser according to Regulation (EC) No 1272/2008.

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:
Stimulation indices of 2.0, 3.0 and 4.9 were determined in a separate test with the positive control substance at concentrations of 5%, 10% and 25% (w/v), respectively, in acetone:olive oil. An EC3 value of 9.9% (w/v) was calculated.

Key result
Parameter:
SI
Value:
1.6
Test group / Remarks:
20%
Remarks on result:
other: 5%: 2.1; 10%: 1.8; 20%: 1.6
Key result
Parameter:
SI
Value:
1.8
Test group / Remarks:
10%
Remarks on result:
other: 5%: 2.1; 10%: 1.8; 20%: 1.6
Key result
Parameter:
SI
Value:
2.1
Test group / Remarks:
5%
Remarks on result:
other: 5%: 2.1 10%: 1.8 20%: 1.6
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: Background: 0; 4.7 (duplicate) Control: 2584.5 (2.582.2 without background) 5%: 5397.8 (5395.5 without background) 10%: 4542.4 (4540.1 without background) 20%: 4183.7 (4184.4 without background)

No deaths occurred during the study period.

The body weight of the animals, recorded prior to the 1stapplication and prior to necropsy,

was within the range commonly recorded for animals of this strain and age.

No symptoms of local toxicity at the ears of the animals and no systemic findings were observed during the study period. Due to the colour of the test item, a redness of the ears could not be analysed. However, no signs of ear swelling occurred.  

Calculation of the EC3 value was not performed, because no test concentration produced a SI of 3 or higher.

Interpretation of results:
GHS criteria not met
Conclusions:
The toxicity potential of Pigment Red 202 is assessed based on analogue approaches. Under the conditions of this LLNA-assay, the test substance was not sensitising.
Executive summary:

In the study the test item dissolved in acetone:olive oil, 4:1 (v/v) was assessed for its possible contact allergenic potential. For this purpose a local lymph node assay was performed in CBA mice (4 females per group) using test item concentrations of 5, 10 and 20% (w/v). The animals did not show any clinical signs during the course of the study and no cases of mortality were observed. In this study stimulation indices (S.I.) of 2.1, 1.8 and 1.6 were determined with the test item at concentrations of 5, 10 and 20% (w/v) in acetone:olive oil, 4:1 (v/v), respectively. A EC3 value could not be determined. The test item was not a skin sensitiser under the conditions tested. The positive control substance was sensitising (EC value 9.9%), thus confirming the validity of the tests system.

Therefore, the test item has not to be classified as skin sensitiser according to Regulation (EC) No 1272/2008.

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 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.