Potassium 4-acetoacetylaminobenzenesulphonate

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:

experimental study

Adequacy of study:

key study

Study period:

October - December 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-compliant guideline study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.6 (Skin Sensitisation)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of study:

guinea pig maximisation test

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Harlan Nossan S.r.I., Correzzana (M!), Italy
- Age at study initiation: 4-5 weeks
- Weight at study initiation: 300-350 g
- Housing: housed in groups of up to 5 animals in stainless steel cages
- Diet (e.g. ad libitum): commercially available laboratory diet (Altromin MSK, A. Rieper S.p.A., Bolzano, Italy)
- Water (e.g. ad libitum): tap water
- Acclimation period: 11 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 45-65%
- Photoperiod (hrs dark / hrs light): fluorescent light to give an artificial cycle of 12 hours light / 12 hours dark

Route:

intradermal and epicutaneous

Vehicle:

water

Concentration / amount:

- intradermal induction: 10% in water
- epidermal induction: 75% in water
- challenge: 20% in water

Route:

epicutaneous, semiocclusive

Vehicle:

water

Concentration / amount:

- intradermal induction: 10% in water
- epidermal induction: 75% in water
- challenge: 20% in water

No. of animals per dose:

- 10 ainmals in test group
- 5 animals in control group

Positive control substance(s):

yes

Remarks:

Mercaptobenzothiazole

Positive control results:

CONTROL SUBSTANCE:
- Mercaptobenzothiazole

RESULTS:
100% positive response in test group and 0% response in control group at challenge

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

20% in water

No. with + reactions:

0

Total no. in group:

9

Clinical observations:

one animal died during the study

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 20% in water. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: one animal died during the study.

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

20% in water

No. with + reactions:

0

Total no. in group:

9

Clinical observations:

one animal died during the study

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 20% in water. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: one animal died during the study.

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

20% in water

No. with + reactions:

0

Total no. in group:

5

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 20% in water. No with. + reactions: 0.0. Total no. in groups: 5.0.

Reading:

2nd reading

Hours after challenge:

48

Group:

negative control

Dose level:

20% in water

No. with + reactions:

0

Total no. in group:

5

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 20% in water. No with. + reactions: 0.0. Total no. in groups: 5.0.

CLINICAL SIGNS:

No clincial signs noted.

MORTALITY:

One animal died during the study.

NECROPSY:

The abdominal cavity ontained a brown fluid material; thoracic cavity contained a red fluid material.

BODY WEIGHTS:

Changes in body weight of surviving animals during the period of the study were generally similar in animals from both test and control groups.

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item does not elicit a sensitisation response in the guinea pig.

Executive summary:

The purpose of the study was to assess the ability of the test substance to cause delayed dermal sensitisation by use of a guinea pig model (Magnusson & Kligman test), following OECD testing method no. 406. 15 animals were used (10 test animals and five control animals). Water was used as vehcile. Applied test item concentrations were 10% for intradermal and 75% for epidermal induction, whereas a 20% solution was used for epidermal exposure in the challenge phase. One animal died during the test. The results obtained in this study indicate that the test substance does not elicit a sensitisation response in the guinea pig, there being no reaction observed at challenge that could not be clearly attributed to irritation.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Source: GLP-report

Migrated from Short description of key information:
The potential of the test substance to induce and elicit delayed dermal sensitisation was assessed by a guinea pig model using the maximisation test of Magnusson and Kligman. These results indicate that the test item does not elicit a sensitisation response in the guinea pig, there being no reaction observed at challenge that could not be clearly attributed to irritation.

Justification for selection of skin sensitisation endpoint:
GLP Klimisch 1 study

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the data available the substance is not classified according to Regulation 1272/2008/EEC (CLP) and according to Directive 67/548/EEC (DSD).