Reaction mass ofDisodium [1-{[2-(hydroxy-kO)-3,5-dinitrophenyl]diazenyl-kN1}naphthalen-2-olato(2-)-kO][3-(hydroxy-kO)-4-{[2-(hydroxy-kO)naphthalen-1-yl]diazenyl-kN1}-7-nitronaphthalene-1-sulfonato(3-)]chromate(2-) andDisodium [1-{[2-(hydroxy-kO)-3,5-dinitrophenyl]diazenyl-kN2}naphthalen-2-olato(2-)-kO][3-(hydroxy-kO)-4-{[2-(hydroxy-kO)naphthalen-1-yl]diazenyl-kN1}-7-nitronaphthalene-1-sulfonato(3-)]chromate(2-)

Endpoint summary

Description of key information

The skin sensitisation potential of the test item was evaluated in two different studies conducted with Guinea pigs and humans, respectively. In a key study, the skin sensitisation potential of the test item was evaluated according toOECD Guideline 406.The test was performed on 10 male and 10 female guinea pigs in the test group and 5 males and 5 females in the control group. The concentrations for the main study were chosen on the basis of a screening study. Guine pigs were given intradermal injections (into the neck region) on the first week; followed by closed patch exposure over the injection sites one week later and challenge exposure in week 5. Concentrations used were: 5 % for intradermal induction, 50 % for epicutaneous induction and 30% for epicutaneous challenge. 24h and 48h after removing the dressings, the challenge reactions were graded according to the Draize scoring scale. Under the experimental conditions, 5 and 10 % of the animals of the test group showed skin reactions 24 and 48 hours respectively. Based on the EU CLP criteria, the test item can be classified as a "non-sensitiser" to the skin. In a supporting study (Section 7.10.4), the sensitising potential of the test item with respect to humans was evaluated in a repeated insult patch test. In this study, the test item was found to have no irritation or sensitisation potential under the conditions tested.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Study start date: 09 March 1993; Experiment start date - 15 March 1993; Experiment end date - 16 April 1993; Study completion date - 27 April 1993.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: Annex V, Part B of Council Directive 67/548/EEC (Commission Directive 92/69/EEC of July 31, 1992

Deviations:

no

GLP compliance:

yes

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

Data from a reliable in vivo test conducted before the enforcement of Commission Regulation (EU) 640/2012 of 06 July 2012 amending, for the purpose of its adaptation to technical progress, Regulation (EC) No. 440/2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) are available.

Specific details on test material used for the study:

DETAILS ON TEST MATERIAL
- Code No.of test material: FAT 20037/C
- Batch No.: 9300001
- Additional specification: IRGALAN SCHWARZ BGL ROH TROCKEN
- Contents/Purity: ca. 80 %
- Physical properties: solid; black powder
- Storage conditions: room temperature
- Expiry date: February, 1998

Species:

guinea pig

Strain:

other: Pirbright White Strain (Tif: DHP)

Sex:

male/female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: CIBA-GEIGY Limited, Animal Production, 4332 Stein / Switzerland
- Weight at study initiation: 330 to 390 g
- Housing: individually in Macrolon cages (Type 3), assigned to the different groups by means of random numbers generated by the random number generator, identified by individual ear tags,
- Diet: ad libitum, standard guinea pig pellets - NAFAG No. 845, Gossau SG
- Water: ad libitum
- Acclimation period: 11 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 30 to 70 %
- Photoperiod: 12 hours light cycle day

IN-LIFE DATES: From: 15 March, 1993; To: 16 April, 1993

Route:

intradermal and epicutaneous

Vehicle:

physiological saline

Concentration / amount:

5 %

Day(s)/duration:

Day 1

Adequacy of induction:

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

Route:

epicutaneous, occlusive

Vehicle:

other: Vaseline

Concentration / amount:

50 %

Day(s)/duration:

Day 8

Adequacy of induction:

highest technically applicable concentration used

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

physiological saline

Concentration / amount:

30 %

Day(s)/duration:

Day 28

Adequacy of challenge:

highest non-irritant concentration

No. of animals per dose:

Test group: 10 male and 10 female guinea pigs
Control group: 5 males and 5 females guinea pigs.

Details on study design:

RANGE FINDING TESTS: On each animal, two concentrations of FAT 20037/C were applied simultaneously on the left and right flank. A naive skin site served as control (not reported). 7 days before application of FAT 20037/C two pairs of intradermal injections of an adjuvant/saline mixture 1:1 (v/v; 0.1 mL per injection) were made simultaneously into the shaved neck of the guinea pigs.

MAIN STUDY
A. INDUCTION EXPOSURE (Intradermal)
- No. of exposures: 1
- Test groups: 1 (10 males and 10 females)
- Control group: 1 (5 males and 5 females)
- Site: the neck region
- Frequency of applications: once
- Concentrations: 5% for the test group

B. INDUCTION EXPOSURE (Epicutaneous)
- No. of exposures: 1
- Exposure period: 24 hours
- Test groups: 1 (10 males and 10 females)
- Control group: 1 (5 males and 5 females)
- Site: flank region
- Frequency of applications: once
- Concentrations: 50% for the test group

C. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1
- Exposure period: 24 hours
- Test groups: 1 (10 males and 10 females)
- Control group: 1 (5 males and 5 females)
- Site: flank region
- Concentrations: 30 % for the test group
- Evaluation: 24 and 48 hours after the challenge

Positive control substance(s):

yes

Remarks:

Potassium dichromate

Positive control results:

Reference values with Potassium dichromate (Test No. 920024)
Experimental starting date: November 11, 1992
Experimental completion date: December 11, 1992

The following concentrations of the reference compound and vehicles were used:
Intradermal induction
Concentration of compound: 0.2 %; Vehicle: physiological saline

Epidermal induction
Concentration of compound: 5 %; Vehicle: vaseline

Epidermal challenge
Concentration of compound: 1 %; Vehicle: vaseline

9 out of 10 animals from the test group had positive reactions 24 and 48 hours after the cahllenge exposure, proving the efficiency of the method.

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

5 % - intradermal, 50 % epicutaneous, 30 % epicutaneous challenge

No. with + reactions:

1

Total no. in group:

20

Remarks on result:

no indication of skin sensitisation

Key result

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

5 % - intradermal, 50 % epicutaneous, 30 % epicutaneous challenge

No. with + reactions:

2

Total no. in group:

20

Remarks on result:

no indication of skin sensitisation

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

no indication of skin sensitisation

Reading:

2nd reading

Hours after challenge:

48

Group:

negative control

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

no indication of skin sensitisation

Reading:

1st reading

Hours after challenge:

24

Group:

positive control

Dose level:

Intradermal induction: 0.2 %; Epidermal induction: 5 %; Epidermal challenge: 1 %.

No. with + reactions:

9

Total no. in group:

10

Remarks on result:

positive indication of skin sensitisation

Reading:

2nd reading

Hours after challenge:

48

Group:

positive control

Dose level:

Intradermal induction: 0.2 %; Epidermal induction: 5 %; Epidermal challenge: 1 %.

No. with + reactions:

9

Total no. in group:

10

Remarks on result:

positive indication of skin sensitisation

5 and 10 % of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings, respectively. However, according to the EU CLP criteria, FAT 20037/C did not show a skin - sensitising (contact allergenic) potential in albino guinea pigs.

Control Group		After 24 hours Positive		After 48 hours Positive
Vehicle control		0/10		0/10
Test article		0/10		0/10
Test Group		After 24 hours		After 48 hours
Vehicle control		0/20		0/20
Test article		1/20		2/20

Interpretation of results:

GHS criteria not met

Conclusions:

The test item was classified as a "non-sensitiser" to the skin.

Executive summary:

The skin sensitisation potential of the test item was evaluated in a study conducted according to OECD Guideline 406. The test was performed on 10 male and 10 female guinea pigs in the test group and 5 males and 5 females in the control group, The concentrations for the main study were chosen on the basis of a pre-study. Guine pigs were given intradermal injections (into the neck region) on the first week; followed by closed patch exposure over the injection sites one week later and challenge exposure in week 5. Concentrations used were: 5 % for intradermal induction, 50 % for epicutaneous induction and 30 % for epicutaneous challenge. Twenty four and forty eight hours after removing the dressings, the challenge reactions were graded according to the Draize scoring scale. Under the experimental conditions, 5 and 10 % of the animals of the test group showed skin reactions 24 and 48 hours respectively, after removing the dressings. Based on the EU CLP criteria, the test item can be classified as a "non-sensitiser" to the skin.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the available information, the substance does not warrant classification for sensitisation according to the CLP-criteria.