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Diss Factsheets

Administrative data

Description of key information

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:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and OECD testing guideline 429 compliant study
Justification for type of information:
See Read across justification document in Chapter 13
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
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
- Age at study initiation: 8 - 12 weeks (beginning of acclimatization)
- Weight at study initiation: mean 18.3 g
- Housing: single caging
- Diet: ad libitum
- Water: ad libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + 3°C
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light):12/12

IN-LIFE DATES: From: 2004-08-27 To: 2004-11-16
Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
5, 10, and 15 % (w/v).
No. of animals per dose:
4
Details on study design:
To determine the highest non-irritant and technically applicable test item concentration, a non-GLP pretest was performed in two mice with concentrations of 2.5, 5, 10, and 15 % (w/v) (pretest excluded from Statement of Compliance). The data showed that the highest test item concentration, which could be technically used, was a 15 % suspension in acetone:olive oil, 4:1 (w/v). Also in other vehicles tested (DMSO, DMF), a higher concentration could not be suspended.
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Statistics:
not needed.
Positive control results:
performed in October 2004 (RCC-CCR Study No. 860600) EC3 = 9.9%
Parameter:
SI
Value:
0.9
Test group / Remarks:
5%
Remarks on result:
other: no indication of skin sensitisation based on the assay
Parameter:
SI
Value:
0.9
Test group / Remarks:
10%
Remarks on result:
other: no indication of skin sensitisation based on the assay
Parameter:
SI
Value:
1.3
Test group / Remarks:
15%
Remarks on result:
other: no indication of skin sensitisation based on the assay
Parameter:
other: disintegrations per minute (DPM)
Value:
3 352.4
Test group / Remarks:
5%
Remarks on result:
other: no indication of skin sensitisation based on the assay
Parameter:
other: disintegrations per minute (DPM)
Value:
3 507.5
Test group / Remarks:
10%
Remarks on result:
other: no indication of skin sensitisation based on the assay
Parameter:
other: disintegrations per minute (DPM)
Value:
4 999.2
Test group / Remarks:
15%
Remarks on result:
other: no indication of skin sensitisation based on the assay

No deaths occurred during the study period.

No symptoms of local toxicity at the ears of the animals and no systemic findings were observed during the study period. Reddening of the ears could not be determined since the ears were dyed red by the test item. However, no other signs of local irritation such as swelling of the ears could be observed.

The body weight of the animals, recorded prior to the 1st application and prior to necropsy, was within the range commonly recorded for animals of this strain and age.

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and OECD testing guideline 429 compliant study
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
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
- Age at study initiation: 8 - 12 weeks (beginning of acclimatization)
- Weight at study initiation: mean 18.3 g
- Housing: single caging
- Diet: ad libitum
- Water: ad libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + 3°C
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light):12/12

IN-LIFE DATES: From: 2004-08-27 To: 2004-11-16
Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
5, 10, and 15 % (w/v).
No. of animals per dose:
4
Details on study design:
To determine the highest non-irritant and technically applicable test item concentration, a non-GLP pretest was performed in two mice with concentrations of 2.5, 5, 10, and 15 % (w/v) (pretest excluded from Statement of Compliance). The data showed that the highest test item concentration, which could be technically used, was a 15 % suspension in acetone:olive oil, 4:1 (w/v). Also in other vehicles tested (DMSO, DMF), a higher concentration could not be suspended.
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Statistics:
not needed.
Positive control results:
performed in October 2004 (RCC-CCR Study No. 860600) EC3 = 9.9%
Parameter:
SI
Value:
0.9
Test group / Remarks:
5%
Remarks on result:
other: no indication of skin sensitisation based on the assay
Parameter:
SI
Value:
0.9
Test group / Remarks:
10%
Remarks on result:
other: no indication of skin sensitisation based on the assay
Parameter:
SI
Value:
1.3
Test group / Remarks:
15%
Remarks on result:
other: no indication of skin sensitisation based on the assay
Parameter:
other: disintegrations per minute (DPM)
Value:
3 352.4
Test group / Remarks:
5%
Remarks on result:
other: no indication of skin sensitisation based on the assay
Parameter:
other: disintegrations per minute (DPM)
Value:
3 507.5
Test group / Remarks:
10%
Remarks on result:
other: no indication of skin sensitisation based on the assay
Parameter:
other: disintegrations per minute (DPM)
Value:
4 999.2
Test group / Remarks:
15%
Remarks on result:
other: no indication of skin sensitisation based on the assay

No deaths occurred during the study period.

No symptoms of local toxicity at the ears of the animals and no systemic findings were observed during the study period. Reddening of the ears could not be determined since the ears were dyed red by the test item. However, no other signs of local irritation such as swelling of the ears could be observed.

The body weight of the animals, recorded prior to the 1st application and prior to necropsy, was within the range commonly recorded for animals of this strain and age.

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Adequate and reliable experimental data on skin sensistization is available for a close structural analoogue Pigment Red 214. 


Pigment Red 214 (CAS 40618-31-3, 863 g/mol)


 


Pigment Red 214 was tested in a Local Lymph Node assays according to GLP and OECD testing guideline 429 (RCC 2005). Concentrations of 5, 10, and 15 % (w/v) in acetone/olive oil (4:1) were applied. Higher concentrations were technically not feasible as shown in a pre-test. Simulation indices were 0.9, 0.9, and 1.3 proving absence of a skin senstising potential. No deaths occurred during the study period. No symptoms of local toxicity at the ears of the animals and no systemic findings were observed during the study period. Reddening of the ears could not be determined since the ears were dyed red by the test item. However, no other signs of local irritation such as swelling of the ears could be observed. The body weight of the animals, recorded prior to the 1st application and prior to necropsy, was within the range commonly recorded for animals of this strain and age.


 


 

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008


The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for skin sensitization under Regulation (EC) No. 1272/2008, as amended for the third time in Directive (EC 618/2012).