Disodium [N-[7-hydroxy-8-[(2-hydroxy-5-mesylphenyl)azo]-1-naphthyl]acetamidato(2-)][2-hydroxy-3-[(2-hydroxy-1-naphthyl)azo]-5-nitrobenzenesulphonato(3-)]chromate(2-)

Endpoint summary

Description of key information

non skin sensitiser.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1995

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Justification for read across is detailed in the report attached to the IUCLID section 13.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Qualifier:

according to guideline

Guideline:

EU Method B.6 (Skin Sensitisation)

Principles of method if other than guideline:

None

GLP compliance:

yes

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

None

Specific details on test material used for the study:

None

Species:

guinea pig

Strain:

Himalayan

Sex:

male/female

Details on test animals and environmental conditions:

NoneTEST ANIMALS- Source: BRL, Biological Research Laboratories Ltd. Wölferstrasse 4, 4414 Füllinsdorf / Switzerland- Females (if applicable) nulliparous and non-pregnant: 30 females /6 females, nulliparous and non-pregnant- Age at study initiation: 5 - 7 weeks- Weight at study initiation: Control and Test Group: 324 - 385 g Pretest: 331 - 399 g- Housing: Individually in Makrol on type-3 cages with autoclaved standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz).- Diet (e.g. ad libitum): Pelleted standard Kliba 342, Batch no. 68/95 guinea pig breeding/maintenance diet ("Kliba", Klingentalmühle AG, CH-4303 Kaiseraugst), ad libitum.- Water (e.g. ad libitum): Community tap water from Füllinsdorf, ad libitum. Once weekly additional supply of ascorbic acid (1 g/1) via the drinking water.- Acclimation period:One week for the control and test group under test conditions after health examination. No acclimatization for the animals of the pretest.Only animals without any visible signs of illness were used for the study- Indication of any skin lesions:ENVIRONMENTAL CONDITIONS- Temperature (°C): 21 - 22 °C- Humidity (%): 56-68%- Air changes (per hr): 10-15 air changes per hour- Photoperiod (hrs dark / hrs light): 12-hour light, 12-hour dark cycle

Route:

epicutaneous, occlusive

Vehicle:

other: Vaselinum album

Concentration / amount:

50% in vaselinum album

Day(s)/duration:

Test day 07

Adequacy of induction:

non-irritant substance, but skin pre-treated with 10% SDS

Route:

intradermal

Vehicle:

other: ethanol

Concentration / amount:

The test article diluted to 5% by emulsion in a 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.

Day(s)/duration:

Test day 01

Adequacy of induction:

highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

other: Vaselinum album

Concentration / amount:

25 % of the test article

Day(s)/duration:

Test day 22

Adequacy of challenge:

highest non-irritant concentration

No. of animals per dose:

10 animals per dose

Details on study design:

RANGE FINDING TESTS: The objective of this investigation was to identify a maximally tolerated concentration of the test article suitable for the induction phase of the main study. In addition, a suitable non-irritant concentration of the test article, by the topical route of administration, was identified for the challenge application. The procedure employed for these investigations was as follows:INTRADERMAL INJECTIONS:Intradermal injections (0.1 ml/site) were made into the clipped flank of two guinea-pigs at concentrations of 5, 3 and 1% of the test article in ethanol. The resulting dermal reactions were assessed 24 hours later. For intradermal induction application a 5 % test article dilution was selected.EPIDERMAL APPLICATIONS:Both flanks of each of 4 guinea pigs were clipped and shaved just prior to the application. Thereafter 4 patches* of filter paper ( 2 x 2 cm) were saturatedwith the test article at A = 50% (this concentration used was found to be the most qualified to assure an optimum technical application procedure), B = 25%,C = 15% and D = 10% of the test article in vaselinum album and applied to the clipped and shaved flanks. The patches were covered by a strip of aluminum foil and firmly secured by elastic plaster wrapped around the trunk and covered with impervious adhesive tape. This procedure ensured the intensive contact of the test article. The dressings were removed after an exposure period of 24 hours. 21 hours after removal of the dressing the application site was depilated with an approved depilatory cream (VEET Cream, Reckitt & Colman AG, CH-4123 Allschwil) to clean the application site from staining produced by the testarticle, so that possible erythema reactions were clearly visible at that time. The depilatory was placed on the patch sites and surrounding areas, and left onfor 3-5 minutes. It was then thoroughly washed off with a stream of warm, running water. The animals were then dried with a disposable towel, and returned to their cages. The reaction sites were assessed 24 and 48 hours after removal of the bandage for erythema and oedema on a numerical basis according to Draize described above.For the epidermal induction the test article at 50% and for challenge procedure the test article at 25% in vaselinum album was selected. MAIN STUDY A. INDUCTION EXPOSURE (intradermal)- No. of exposure: 01 - Exposure period: not applicable - Test groups: 3 injections administered 1) 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline. 2) The test article, diluted to 5% with ethanol. 3) The test article diluted to 5% by emulsion in a 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline. - Control group: 3 injections administered 1) 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline. 2) Ethanol 3) 1:1 (w/w) mixture of vaselinum album in a 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline. - Site: scapular region (approximately 6 x 8 cm) - Frequency of applications: OnceB. INDUCTION EXPOSURE (epidermal)- No. of exposure: 01 - Exposure period: 4 hours - Site: : scapular area (approximately 6 x 8 cm) - Frequency of applications: Once- Concentration: 50% in vaselinum album C. CHALLENGE EXPOSURE - No. of exposures: 01 - Day(s) of challenge: Test day 22 - Exposure period: 04 hours - Site: left and right flank of each guinea-pig - Concentrations: 25 % - Evaluation (hr after challenge): 24 and 48 hours after the removal of the dressing the application sites were assessed for erythema and oedema using the numerical scoring system according to Draize. OTHER:

Challenge controls:

None

Positive control substance(s):

yes

Remarks:

2- mercaptobenzothiazol

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

25 %

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

No clinical observation recorded

Key result

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

25 %

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

No clinical observation recorded

None

Interpretation of results:

other: Non classified

Remarks:

CLP Regulation 1272/2008 and its amendments

Conclusions:

Not a skin sensitiser.

Executive summary:

A guinea pig maximisation test was performed to determine the sensitization potential of FAT 20013 according to the OECD Guideline 406 and EU Method B.6 (Skin Sensitisation).

No positive reactions were observed in the animals either when treated with vaselinum album alone or when treated with the test article at 25 % in vaselinum album. The subtance is therefore, classified as a non-sensitiser in albino guinea pigs according to the grading of Magnusson and Kligman.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

An in vivo test on guinea pig maximisation was performed to determine the sensitization potential of the Similar substance 01 according to the OECD Guideline 406 and EU Method B.6 (Skin Sensitisation).

No positive reactions were observed in the animals either when treated with vaselinum album alone or when treated with the test article at 25 % in vaselinum album. The substance is therefore, classified as a non-sensitiser in albino guinea pigs according to the grading of Magnusson and Kligman.

Based on the read across principle(read-across from supporting substance -structural analogue or surrogate), the results can be considered assessment of the registered substance.

Justification for read across is detailed in the report attached to the IUCLID section 13.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the available data of the GPMT selected as key study, the registered substance does not warrant classification for skin sensitisation under the CLP (1272/2008) Regulation.