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

Endpoint summary

Description of key information

Pigment Red 242 (nano form): not sensitising (LLNA)

Structure analogue Pigment Red 144 (nano form and not specified form): not sensitising (LLNA)

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Reference 1

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

Reference 2

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and OECD guideline compliant study

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, NL - 5960 AD Horst
- Age at study initiation: 8 - 12 weeks (beginning of acclimatization)
- Weight at study initiation: mean 18.5g
- Housing: single
- 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: 2004-11-03 To: 2004-11-09

Vehicle:

acetone/olive oil (4:1 v/v)

Concentration:

7.5, 15 and 30%

No. of animals per dose:

4

Details on study design:

RANGE FINDING TESTS:
- Compound solubility: The data showed that the highest test item concentration, which can be used was a 30 % suspension in acetone:olive oil, 4:1 (viv). In DMF or DMSO only up to 20 % could be suspended
- Irritation: In a non-GLP conform pre-test in !wo mice, test item concentrations of 5, 10, 20, and 30 % (w/v) were tested on one ear each. No irritation effects were observed at these concentrations after a single application. (Due to the intense red colour of the test item local irritation reactions such as ear redness could not be detected" No swelling of the ears was observed.)
- Lymph node proliferation response: not measured in the range-finder

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: 3H-methyl thymidine incorporation
- Criteria used to consider a positive response: 3fold increase in Stimulation index compared to vehicle control

TREATMENT PREPARATION AND ADMINISTRATION: Substance was suspended in vehicle on the day of treatment.

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

Statistics:

Included for body weight and SI

Positive control results:

performed in April 2004, a-Hexylcinnamaldehyde in Acetone/olive oil. EC3 = 6.3%

Parameter:

SI

Value:

ca. 0.5

Test group / Remarks:

Concentration 30%

Parameter:

SI

Value:

ca. 0.7

Test group / Remarks:

Concentration 15%

Parameter:

SI

Value:

ca. 0.8

Test group / Remarks:

Concentration 7.5%

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: DPM per lymph node: Control: 521 7.5% = 424 15% = 348 30% = 259

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)

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

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).