Tetrasodium 7-[[2-[(aminocarbonyl)amino]-4-[[4-chloro-6-[[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]phenyl]azo]naphthalene-1,3,6-trisulphonate

Endpoint summary

Description of key information

Non sensitising

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Remarks:

an in vitro or in chemico skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1992

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Principles of method if other than guideline:

Induced hypersensitive response of experimental animals to allergen challenge. Skin sensitization is immune skin reactions in guinea pigs is reflected blood flow, swelling.

GLP compliance:

not specified

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

A LLNA study has not been conducted because adequate data from guinea pig Maximisation test study are already available.

Species:

guinea pig

Sex:

female

Details on test animals and environmental conditions:

- Numbero of animals: 20
- Non pregnant
- Weight: 250-350 g
- Diet: KO 16 ad libitum
- Water: drinking water with ascorbic acid
- Cage: T5 (supplied by Velaz)

Route:

intradermal and epicutaneous

Vehicle:

other: vaseline

Concentration / amount:

Intradermal:
0,1 mL at 25 %;
0,1 mL at 5 % of dye
0,1 mL at 5% of dye and adjuvant (1:1)
Epicutaneous: 25 % of dye in vaseline

Route:

intradermal and epicutaneous

Vehicle:

other: vaseline

Concentration / amount:

Intradermal:
0.1 mL at 25 %
0.1 mL at 5 % of dye
0.1 mL at 5 % of dye and adjuvant (1:1)
Epicutaneous: 25 % of dye in vaseline

No. of animals per dose:

2

Details on study design:

- Route of application: injection and patch application
- Exposure period: 72 hours
- Post-exposure period of observation: 14 days

Positive control substance(s):

yes

Reading:

1st reading

Hours after challenge:

1

Group:

test chemical

Dose level:

0,1

No. with + reactions:

3

Total no. in group:

20

Clinical observations:

weak swelling; edema

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 1.0. Group: test group. Dose level: 0,1. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: weak swelling; edema.

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

0,1

No. with + reactions:

3

Total no. in group:

20

Clinical observations:

weak swelling; edema

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0,1. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: weak swelling; edema.

Reading:

1st reading

Hours after challenge:

48

Group:

test chemical

Dose level:

0,1

No. with + reactions:

3

Total no. in group:

20

Clinical observations:

weak swelling; edema

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0,1. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: weak swelling; edema.

Group:

negative control

Remarks on result:

no indication of skin sensitisation

Group:

positive control

Remarks on result:

other: not reported

Interpretation of results:

GHS criteria not met

Conclusions:

Non sensitising

Executive summary:

Method

To assess the allergenic potential the test substance has been tested in albino guinea pigs, according to the OECD guideline 406.

Results

Positive reaction was found on 3 animals of the total 20 (15 % corresponding to an intradermal induction dose of 5 %).

Conclusion

Non sensitising.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

To assess the allergenic potential the test substance has been tested in albino guinea pigs, according to the OECD guideline 406.

Positive reaction was found on 3 animals of the total 20 (15 % corresponding to an intradermal induction dose of 5 %).

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

SKIN SENSITIZATION

Category 1

According CLP Regulation N. 1272/2008, a substances shall be classified as skin sensitisers (Category 1) where data are not sufficient for sub- categorisation (1A and 1B) in accordance with the following criteria:

(a) if there is evidence in humans that the substance can lead to sensitisation by skin contact in a substantial number of persons; or

(b) if there are positive results from an appropriate animal test ( according to 3.4.2.2.4.1).

At this point, when an adjuvant type guinea pig test method for skin sensitisation is used, a response of at least 30 % of the animals is considered as positive. For a non-adjuvant guinea pig test method a response of at least 15 % of the animals is considered positive.

Sub-category 1A

Substances showing a high frequency of occurrence in humans and/or a high potency in animals can be presumed to have the potential to produce significant sensitisation in humans. Severity of reaction may also be considered.

Specific criteria:

Local lymph node assay-EC3 value ≤ 2 %

Guinea pig maximisation test-≥ 30 % responding at ≤ 0,1 % intradermal induction dose or ≥ 60 % responding at > 0,1 % to ≤ 1 % intradermal induction dose

Buehler assay - ≥ 15 % responding at ≤ 0,2 % topical induction dose or ≥ 60 % responding at > 0,2 % to ≤ 20 % topical induction dose

Sub-category 1B

Substances showing a low to moderate frequency of occurrence in humans and/or a low to moderate potency in animals can be presumed to have the potential to produce sensitisation in humans. Severity of reaction may also be considered.

Local lymph node assay - EC3 value > 2 %

Guinea pig maximisation test- ≥ 30 % to < 60 % responding at > 0,1 % to ≤ 1 % intradermal induction dose or ≥ 30 % responding at > 1 % intradermal induction dose

Buehler assay - ≥ 15 % to < 60 % responding at > 0,2 % to ≤ 20 % topical induction dose or ≥ 15 % responding at > 20 % topical induction dose.

The tested substance has not to be classified as skin sensitiser because the highest positive reaction value of the test is 15 % responding at 5 % intradermal induction dose.