N,N'-(2,5-dichloro-1,4-phenylene)bis[4-[(2,5-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]

Endpoint summary

Description of key information

Non skin sensitizing (LLNA, GLP).

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline 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)

Specific details on test material used for the study:

- Substance type: red solid
- Physical state: solid
- Analytical purity: 99.91%
- Purity test date: 20 August 2004
- Lot/batch No.: W02002
- Expiration date of the lot/batch: August 20, 2009
- Stability under test conditions: stable
- Storage condition of test material: at room temperature in the dark
- Stability in solvent: > 24 hrs in DMSO at room temperature

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

Remarks on result:

other: 0.9, 0.9, and 1.3

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: 3855.2 (control) 3352.4 (5%) 3507.5 (10%) 4999.2 (15%)

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:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

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.