1,4-bis(mesitylamino)anthraquinone

Endpoint summary

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:

2007

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: well performed OECD guideline study without GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

GLP compliance:

no

Remarks:

The study was not performed under GLP but the experiments were conducted according to GLP standards in a certified laboratory and the quality of the results is considered equivalent to the results obtained from a GLP compliant study

Type of study:

mouse local lymph node assay (LLNA)

Species:

mouse

Strain:

other: CBA/CaOlaHsd

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Harlan Netherlands; B.V. Postbus 6174; NL - 5960 AD Horst / The Netherlands
- Age at study initiation: 7 - 12 weeks
- Weight at study initiation: 18.1 - 19.8 grams
- Housing: Single caging. Makrolon Type I, with wire mesh top (EHRET GmbH, D-79302 Emmendingen)
- Bedding: granulated soft wood bedding (Harlan Winkelmann GmbH, D-33178 Borchen)
- Diet: pelleted standard diet, (Harlan Winkelmann GmbH, D-33178 Borchen) (ad libitum):
- Water: tap water, (Gemeindewerke, D-64380 Rossdorf) (ad libitum):
- Acclimation period: Under test conditions after health examination.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +-3°C
- Humidity (%): 30 - 92
- Photoperiod: artificial light 6.00 a.m. - 6.00 p.m.

Vehicle:

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

Concentration:

0.0, 6.25, 12.5, 25.0 %

No. of animals per dose:

4

Positive control substance(s):

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

Positive control results:

EC3 = 6.7% (w/v) (in acetone:olive oil (4+1))

Parameter:

SI

Remarks on result:

other: S.I. 6.25 % (w/v): 2.16 12.5 % (w/v): 1.50 25.0 % (w/v): 1.23

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: DPM per lymph node Control: 565.1 6.25 % (w/v): 1218.6 12.5 % (w/v): 847.0 25.0 % (w/v): 696.6

Test item concentration % (w/v)	Group	Measurement DPM	Calculation			Result
			DPM-BGa)	number of lymph nodes	DPM per lymph nodeb)	S.I.
---	BG I	30.89	---	---	---	---
---	BG II	21.80	---	---	---	---
---	1	4547.15	4520.8	8	565.1
6.25	2	9775.26	9748.9	8	1218.6	2.16
12.5	3	6802.58	6776.2	8	847.0	1.50
25.0	4	5599.37	5573.0	8	696.6	1.23

Vehicle: acetone:olive oil (4+1)

BG = Background (1 ml 5% trichloroacetic acid) in duplicate

1 = Control Group

2-4 = Test Group

S.I. = Stimulation Index

a) = The mean value was taken from the figures BG I and BG II

b) = Since the lymph nodes of the animals of a dose group were pooled, DPM/node was determined by dividing the measured value by the number of lymph nodes pooled

The EC3 Value could not be calculated, since all SI´s are below 3.

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item was not a skin sensitiser in this assay.

Executive summary:

In the study the test item dissolved in acetone:olive oil (4+1) was assessed for its possible contact allergenic potential.

For this purpose a local lymph node assay was performed using test item concentrations of 6.25, 12.5, and 25 %.

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 2.16, 1.50, and 1.23 were determined with the test item at concentrations of 6.25, 12.5, and 25 % in acetone:olive oil (4+1), respectively.

The test item was not a skin sensitiser in this assay. The EC3 value could not be calculated, since all S.I. were below 3.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Migrated from Short description of key information:
In this LLNA Stimulation Indices (S.I.) of 2.16, 1.50, and 1.23 were determined with the test item at concentrations of 6.25, 12.5, and 25 % in acetone:olive oil (4+1), respectively.

Justification for selection of skin sensitisation endpoint:
no alternative study available

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

All S.I. values were below 3 the threshold value for classification.

Since these findings do not meet the criteria for classification with respect to skin sensitisation according to the rules laid down in Directive 67/548EEC and in Regulation (EC) No 1272/2008, classification is not warrantable.