2,3,4,4'-tetrakis(6-diazo-5,6-dihydro-5-oxo-1-naphthylsulfonato)benzophenone

Endpoint summary

Description of key information

Based on the results of a GPMT, the test substance was considered not to have a skin sensitization potential.

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:

4th August to 4th September 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method B.6 (Skin Sensitisation)

Version / remarks:

1984

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Version / remarks:

1981

Deviations:

no

GLP compliance:

yes

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

The study was conducted well before the LLNA became the recommended standard in vivo method for evaluating the skin sensititsation potential.

Species:

guinea pig

Strain:

other: Pirbright-White guinea pig

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF breeding colony
- Weight at study initiation: 234-306 g
- Housing: MAkrolon type 4 cage, groups of 5
- Diet: ad libitum Altromin 3112
- Water: ad libitum tap water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 3
- Humidity (%): 55 +/- 20
- Photoperiod (hrs dark / hrs light): 12/12

Route:

intradermal

Vehicle:

paraffin oil

Concentration / amount:

1 %

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:

petrolatum

Concentration / amount:

0.5 g test substance, 25 % in petrolatum

Day(s)/duration:

Day 8

Adequacy of induction:

other: non-irritant substance

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Concentration / amount:

0.5 g test substance, 25 % in petrolatum

Day(s)/duration:

Day 22

No. of animals per dose:

Treatment group: 10, Control group: 5, Escort group: 5

Details on study design:

RANGE FINDING TESTS:
The primary non-irritant concentration was determined in a dermal-occlusive test with test substance concentrations of 1, 5 and 25 % in petrolatum. No signs of irritation occurred at the different concentrations.
To determine the tolerance of intradermal injections, each of the following preparations was administered twice by intradermal injection to 3 guinea pigs: 0.2, 1 and 5 % in semi-liquid paraffine. The injections with 1 and 5 % preparations caused very sight to moderate erythema and edema. The injections with the 0.2 % preparation caused very slight to moderate erythema and edema. Based on this test, a 1 % preparation was selected for the intradermal injections in the main test.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and dermal)
- Exposure period: Day 1 intradermal induction, Day 8 dermal application
- Site: injections: dorsal, dermal applications: same area
- Duration: dermal application: 24 hours under occlusion
- Concentrations: intradermal: 1 %, dermal: 25%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 22
- Exposure period: 24 hours
- Site: left flank
- Concentrations: 25 %
- Evaluation (hr after challenge): 24 and 38 hours after removal of dressing

Challenge controls:

25 % test substance in petrolatum

Positive control substance(s):

no

Group:

positive control

Remarks on result:

not measured/tested

Group:

negative control

Remarks on result:

not measured/tested

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

25 % in petrolatum

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

no indication of skin sensitisation

Key result

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

25 % test substance

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

Body weight gain of the animals was not impaired.

Remarks on result:

no indication of skin sensitisation

Interpretation of results:

GHS criteria not met

Conclusions:

Under the given experimental conditions, the test material induced no reactions. Therefore, the test item is considered not to cause skin sensitisation.

Executive summary:

The purpose of this GPMT assay was to identify the contact allergenic potential of the test item. The test was performed according to OECD Guideline No 406. Intradermal induction was performed using 1 % test item in semi-liquid paraffine. Dermal induction and challenge treatment were carried out with 25 % test substance in petrolatum. Based on the results of this study there is no evidence for a sensitizing property of the test item.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

The purpose of this GPMT assay was to identify the contact allergenic potential of the test item. The test was performed according to OECD Guideline No 406. Intradermal induction was performed using 1 % test item in semi-liquid paraffine. Dermal induction and challenge treatment were carried out with 25 % test substance in petrolatum. Based on the results of this study there is no evidence for a sensitizing property of the test item.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on skin sensitization, the test item is not considered to be classified according to Regulation (EC) No 1272/2008 (CLP), as amended for the seventeenth time in Regulation (EU) 2021/849.