Ethyl acetoacetate

Endpoint summary

Description of key information

The study was performed in 1981 according to OECD 406 using the footpad method. After intradermal induction with FCA (control group) and 1% test item in FCA, ten test animals and ten control animals were both challenged with 0.1% solution of EAA in the vehicle (solution of acetone, dioxane and GP-fat). No difference in the dermal responses were noted between the control animals and the test animals, based on the criteria cited in this study. The test substance was not considered to be a dermal sensitizer in guinea pigs.

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:

November 23 - December 3, 1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

this study was performed in 1981, prior to implementation of domestic and international good laboratory practice standards. The study was conducted using standard procedures used in the performing laboratory at that time. However, there are some gaps in the study design itself, as there was no re-challenge as in the standard maximization test. Therefore, the study was assessed as Klimisch 2 study.

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Version / remarks:

of 12 May 1981 (Footpad method)

Deviations:

no

GLP compliance:

no

Type of study:

Freund's complete adjuvant test

Justification for non-LLNA method:

this study was performed in 1981, prior to implementation of domestic and international good laboratory practice standards and before OECD guideline n0. 429 was available

Specific details on test material used for the study:

- Lot-no.: Lot C11
- Storage: no data

Species:

guinea pig

Strain:

not specified

Sex:

male/female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: not known
- Weight at study initiation: 328-522 grams
- Housing: single housing

Route:

intradermal

Vehicle:

other: 7:2:1 solution of acetone / dioxane / guinea pig fat

Concentration / amount:

Ten guinea pigs (Numbers 634-643) were injected in the footpad, with 0.05 mL of FCA (control group). Atthe same time, the remaining ten guinea pigs (Numbers 644-653) were injected in the same manner with 0.05 mL of a suspension of FCA containing 1% test substance (test group).

Day(s)/duration:

7 days

Adequacy of induction:

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

No.:

#1

Route:

epicutaneous, open

Vehicle:

other: 7:2:1 solution of acetone / dioxane / guinea pig fat

Concentration / amount:

The animals were then challenged with 0.3 mL of a 0.1% solution of the test substance (the concentration was based on results of the irritation screen) in the vehicle.

Day(s)/duration:

24 & 48 hours

Adequacy of challenge:

not specified

No. of animals per dose:

PRIMARY IRRITATION SCREENING:
- Five female guinea pigs

MAIN TEST:
- Induction & Challenge: Ten male guinea pigs each for control and test group

Details on study design:

This dermal sensitization study was conducted using the footpad method.

PRIMARY IRRITATION SCREENING
In a primary irritation screening, five female guinea pigs previously exposed to Freund's complete adjuvant (FCA), were administered topical doses of a 1% solution of the test substance in a vehicle of acetone, dioxane, and guinea pig fat (7:2:1). Signs of initation included slight to moderate erythema at the 24- and 48-hour examinations for all guinea pigs. Therefore, a decision was made to use a concentration of 0.1% of the test substance in the vehicle for the challenge application of the sensitization study.

INDUCTION
For the induction phase, twenty male guinea pigs weighing 328-387 grams were assigned to one of two groups. Ten guinea pigs were injected in the footpad with 0.05 mL of FCA (control group). At the same time, the remaining ten guinea pigs were injected in the same manner with 0.05 mL of a suspension of FCA containing 1% test substance (test group).

CHALLENGE
Seven days later, the hair was removed from the backs of the twenty guinea pigs with an electric clipper. The animals were then challenged with 0.3 mLof a 0.1% solution of the test substance (the concentration was based on results of the irritation screen) in the vehicle. The guinea pigs were depilated24 hours after the challenge dose and the reaction to the topical challenge was scored. The next day (48 hours after challenge) the reaction was scored again.

Challenge controls:

none

Positive control substance(s):

no

Positive control results:

no positive control tested

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

0.1%

No. with + reactions:

10

Total no. in group:

10

Clinical observations:

None

Remarks on result:

no indication of skin sensitisation

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

0.1%

No. with + reactions:

10

Total no. in group:

10

Clinical observations:

None

Remarks on result:

no indication of skin sensitisation

Key result

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

0.1%

No. with + reactions:

10

Total no. in group:

10

Clinical observations:

None

Remarks on result:

no indication of skin sensitisation

Key result

Reading:

2nd reading

Hours after challenge:

48

Group:

negative control

Dose level:

0.1%

No. with + reactions:

10

Total no. in group:

10

Clinical observations:

None

Remarks on result:

no indication of skin sensitisation

Key result

Group:

positive control

Remarks on result:

not measured/tested

Following the challenge application, slight dermal responses were noted for all ten animals assigned to the control group and for all ten animals assigned to the test group. Since there was no difference in the dermal responses between the control group of animals and the test group of animals, the test substance was not considered to be a dermal sensitizer in guinea pigs.

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

When animals were challenged with a concentration of 0.1% test substance in the vehicle, no difference in the dermal responses were noted between the control animals and the test animals, based on the criteria cited in this study. The test substance was not considered to be a dermal sensitizer in guinea pigs.

Executive summary:

The study was performed in 1981 as non-GLP according to OECD 406 using the footpad method. After intradermal induction with FCA (control group) and 1% test item in FCA, ten test animals and ten control animals were both challenged with 0.1% solution of EAA in the vehicle (solution of acetone, dioxane and GP-fat). No difference in the dermal responses were noted between the control animals and the test animals, based on the criteria cited in this study. The test substance was not considered to be a dermal sensitizer in guinea pigs. Based on results of this study, the test substance requires no label for sensitization by skin contact.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Justification for selection of skin sensitisation endpoint: non GLP-study following OECD-guideline; Klimisch 2

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information:

There is no indication for respiratory irritation/sensitization from handling and use.

Justification for classification or non-classification

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