3,3'-[(9,10-dihydro-9,10-dioxo-1,4-anthrylene)diimino]bis[N-cyclohexyl-2,4,6-trimethylbenzenesulphonamide]

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:

2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: current guideline; GLP

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:

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: 8-12 weeks
- Weight at study initiation:
- Housing: single; Makrolon Type I, with wire mesh top
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-3
- Humidity (%): 30 - 86
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

other: methyl ethyl ketone

Concentration:

6,25 -12,5 -25 % (w/v)

No. of animals per dose:

4

Positive control substance(s):

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

Positive control results:

positive (SI = 2,29 to 8,44)

Parameter:

SI

Remarks on result:

other: 0,8

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: < 465 per lymph node

Vehicle: methyl-ethyl-ketone

Test item concentration % (w/v)	Group	Measurement DPM	Calculation			Result
			DPM-BGa)	number of lymph nodes	DPM per lymph nodeb)	S.I.
---	BG I	0,0	---	---	---	---
---	BG II	9,0	---	---	---	---
---	CG 1	4661,5	4657,0	8	582,1
6,25	TG 2	3721,3	3716,8	8	464,6	0,8
12,5	TG 3	3290,7	3286,2	8	410,8	0,7
25	TG 4	3535,1	3530,6	8	441,3	0,8

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

CG = Control Group

TG = 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

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material did not induce sensitisation raction in mice in an LLNA assay.

Executive summary:

In the study the test item dissolved in methyl ethyl ketone 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. After the second application reddening of the ears could not be determined since the ear skin of the animals was dyed blue by the test item.

In this study Stimulation Indices (S.I.) of 0.8, 0.7, 0.8 were determined with the test item at concentrations of 6.25, 12.5, and 25 % (w/v) in methyl ethyl ketone, respectively.

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

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

No sensitising potential was detected in mice using a local lymph node assay employing three concentrations. The stimulation indices were all below 0.8.

Migrated from Short description of key information:
No sensitising potential was detected in mice using a local lymph node assay.

Justification for selection of skin sensitisation endpoint:
Only study available

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information:

No dermal sensitising potential was detected in mice using a local lymph node assay. For the dertermination of respiratory sensitisation no method is available.

Justification for classification or non-classification

The LLNA showed a clear negative result (not sensitising) therefore a classification is not warranted.