Disodium [6-[(2-anilino-1-naphthyl)azo]-2,4-dinitrophenolato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]naphthalene-1-sulphonato(3-)]chromate(2-)

Endpoint summary

Description of key information

Skin sensitiser based on results of GPMT.

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:

From July 27th to August 29th, 1994

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Justification for type of information:

Details on the read-across are available in section 13.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Version / remarks:

adopted July 17, 1992

Qualifier:

according to guideline

Guideline:

EU Method B.6 (Skin Sensitisation)

GLP compliance:

yes (incl. QA statement)

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

Experiment already available.

Species:

guinea pig

Strain:

Himalayan

Sex:

male

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: BRl, Biological Research laboratories ltd. Wölferstrasse 4, 4414 Füllinsdorf/Switzerland.
- Age at study initiation: 5 - 7 weeks.
- Weight at study initiation: 336 - 391 g.
- Housing: individually in Makrolon type-3 cages with autoclaved standard softwood bedding.
- Diet: ad libitum.
- Water: ad libitum.
- Acclimation period: 1 week.

ENVIRONMENTAL CONDITIONS
- Temperature: 21 - 24 °C
- Humidit:: 52 - 74 %
- Air changes: 10-15 per hr
- Photoperiod: 12 hrs dark / 12 hrs ligh

Route:

intradermal

Vehicle:

water

Concentration / amount:

5 %

Route:

epicutaneous, occlusive

Vehicle:

water

Concentration / amount:

25 %

Route:

epicutaneous, occlusive

Vehicle:

water

Concentration / amount:

25 %

Day(s)/duration:

1

No. of animals per dose:

Control: 5 animals
Treated: 10 animals

Details on study design:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1 intradermal, 1 epidermal.
- Exposure period: 8 days.
- Test groups: 10 animals
- Control group: 5 animals
- Site: scapular area.
- Frequency of applications: 2 at a weeks distance.

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 22
- Exposure period: 24 h
- Site: flank
- Concentrations: 25 %
- Evaluation: 24 and 48 hr after challenge.

Challenge controls:

Opposite flank

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

25 %

No. with + reactions:

0

Total no. in group:

5

Clinical observations:

no

Reading:

2nd reading

Hours after challenge:

48

Group:

negative control

Dose level:

25 %

No. with + reactions:

0

Total no. in group:

5

Clinical observations:

no

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

25 %

No. with + reactions:

10

Total no. in group:

10

Clinical observations:

no

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

25%

No. with + reactions:

10

Total no. in group:

10

Clinical observations:

no

Group:

positive control

Remarks on result:

other: no data available

Test Group Skin Response after challenge test article-treated, 25 % in distilled water

Animal	Sex	erythema (24 h)	edema (24 h)	erythema (48 h)	edema (48 h)
11	male	1	0	1	0
12	male	1	0	1	0
13	male	2	0	3	0
14	male	2	0	2	0
15	male	3	0	2	0
16	male	1	0	2	0
17	male	2	0	2	0
18	male	2	0	3	0
19	male	2	0	1	0
20	male	1	0	1	0

 

Interpretation of results:

other: Skin Sens 1B, according to the CLP Regulation (EC) No 1272/2008

Conclusions:

Test item caused skin reactions after challenge in all treated animals

Executive summary:

To assess the allergenic potential of test item in albino guinea pigs, the Maximization-Test of B. Magnusson and A.M. Kligman (1969) was used.

Five males were used as control group and 10 males were used as test group.

The highest non-irritating test article concentration used for challenge application was 25 % in bi-distilled water.

All treated animals of test group showed erythematous skin reactions 24 and 48 hours after epidermal challenge exposure and test material is judged skin sensitising.

Conclusion

Skin sensitizer; more than 30 % responding at an intradermal induction dose higher than 1 %.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

There are no information about the skin sensitisation potential of Acid Black 222, thus available information on the structural analogue Similar Substance 01 have been taken into consideration; the read across approach can be considered as appropriate and suitable to assess the property under investigation. Details are available in section 13.

Similar Substance 01 was tested for skin sensitisation potential in a Guinea Pigs the Maximization-Test, outlined by Magnusson and Kligman (1969). The highest non-irritating test article concentration used for challenge application was 25 % in bi-distilled water. All treated animals of the test group showed erythematous skin reactions 24 and 48 hours after epidermal challenge exposure and test substance was judged skin sensitising. More than 30 % animals showed reactions responding to an intradermal induction dose higher than 1 %.

Similar outcomes were obtained in a second GPMT performed on Similar Substance 01. Under the experimental conditions, 80 % and 90 % of animals of test group showed skin reactions 24 and 48 hours, respectively, responding to intradermal induction dose higher than 1 %.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

According to the CLP Regulation (EC) No 1272/2008, 3.4.2.2 skin sensitisation section, skin sensitizer means a substance that will lead to an allergic response following skin contact. Effects seen in either humans or animals will normally justify classification in a weight of evidence approach for skin sensitizers.

In the experiments performed on an analogue, more than 30 % of animals showed reactions responding to an intradermal induction dose higher than 1 %; thus, a classification as skin sensitizer, category 1B (i.e. Skin Sens. 1B, H317) of the CLP Regulation (EC) No 1272/2008, is applied to Acid Black 222.