Potassium 4-acetoacetylaminobenzenesulphonate

Skin sensitisation

Administrative data

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

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

no

Test guideline 2

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

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Substance name LZ699.00
- Storage: Keep container tightly closed. Store in dry, cool and well-ventilated place. Do not store in heat or direct sunlight.
- Aggregate state/appearance: solid
- Colour: white to yellowish
- Odour: Odourless

In vivo test system

Test animals

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

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal and epicutaneous

Vehicle:

water

Induction 2

Concentration / amount:

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

Challenge

Challenge 1

Route:

epicutaneous, semiocclusive

Vehicle:

water

Challenge 2

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

Results and discussion

Positive control results:

CONTROL SUBSTANCE:
- Mercaptobenzothiazole

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

In vivo (non-LLNA)

Results

Results 1

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.

Results 2

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.

Results 3

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.

Results 4

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.

Any other information on results incl. tables

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.

Applicant's summary and conclusion

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.