Disodium hydrogen bis[3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]naphthalene-1-sulphonato(3-)]chromate(3-)

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

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

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Current guideline, GLP, full report performed on the analogue substance

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

GLP compliance:

yes (incl. QA statement)

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

At the time of testing LLNA was not 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 9- Housing: single- Diet (e.g. ad libitum): ad lib.- Water (e.g. ad libitum): ad lib.- Acclimation period: 1 weekENVIRONMENTAL CONDITIONS- Temperature (°C): 21 - 24- Humidity (%): 52 - 74- Air changes (per hr): 10-15- Photoperiod (hrs dark / hrs light): 12/12

Route:

intradermal and epicutaneous

Vehicle:

water

Concentration / amount:

intradermal: 5 %epidermal induction: 25 %epidermal challenge: 25 %

Route:

epicutaneous, occlusive

Vehicle:

water

Concentration / amount:

intradermal: 5 %epidermal induction: 25 %epidermal challenge: 25 %

No. of animals per dose:

Control: 5Treated: 10

Details on study design:

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

Challenge controls:

Opposite flank

Positive control substance(s):

not specified

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

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 5.0. 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

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 5.0. 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

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 %. No with. + reactions: 10.0. Total no. in groups: 10.0. 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

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: no.

Reading:

other:

Group:

positive control

Remarks on result:

other: see remarks

Test Group Skin Response after challenge TEST ARTICLE-TREATED, 25% in distilled water

Animal	Sex	erythema	edema	erythema	edema
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:

sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The analogue substance was tested for skin sensitizing properties following OECD 406 (GMPT). Under the experimental conditions the substance is considered as strong skin sensitizer.

Executive summary:

To assess the allergenic potential of the analogue substance 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 the test group showed erythematous skin reactions 24 and 48 hours after epidermal challenge exposure and the test material is judged skin sensitising.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

Annex VII of the REACH Regulation includes a requirement for in chemico/in vitro tests as a first step for addressing skin sensitisation (section 8.3.1). Only in the case that the in chemico/in vitro methods are not applicable for the substance, or the results are not adequate for classification and risk assessment, can an in vivo skin sensitisation study (preferably Local Lymph Node Assay, EU B.42 / OECD TG 429) be performed (section 8.3.2).

The test item is an UVCB colored substance which are parameters that set the substance out of the applicability domains of the in-place validated in vitro testing (DPRA and h-Clat). Consequently, a trigger for an in vivo testing needs to be considered. However, certain steps need to take place before any testing (in vitro or in vivo) is conducted as described in the introductory paragraph to Annex VII, i.e. assessment of all available information, which among other suggest to consider data from structurally related substances (read-across approach).

One study (OECD 406 GPMT ) on the analogue substance indicates that the test material is a strong sensitizer by inducing skin hypersensitvity in 80 to 100 % of the treated animals.

Based on the read across justification, the test item can be considered as strong sensitizer.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

According to the CLP Regulation (EC n. 1272/2008) the following classifications apply:

skin sensitizer Cat 1A, with GPMT:

≥ 30 % is responsive to ≤ 0,1 % of the intradermal induction dose or

> 60 % is responsive to > 0,1 %- ≤ 1 % of the intradermal induction dose

 

skin sensitizer Cat 1B, with GPMT

≥ 30 % to < 60 % is responsive to > 0,1 % - ≤ 1 % of the intradermal induction dose or,

≥ 30 % is responsive to > 1 % of the intradermal induction dose

 

Based on the results of the skin sensitization test (GPMT) the substance is classified as strong skin sensitizer