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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data from secondary source

Data source

Reference
Reference Type:
secondary source
Title:
SIDES Dossier for Ethyl Acetate, CAS No. 141-78-6
Author:
OECD HPV Chemical Programme
Year:
2007
Bibliographic source:
SIDS Dossier, approved at SIAM 14 (26-28 March, 2002) revised May 2007

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
Skin sensitization study of Ethyl Acetate was performed in guinea pig by Guinea pig Magnusson-Kligman maximation test
GLP compliance:
not specified
Type of study:
other: Guinea pig Magnusson-Kligman maximation test
Justification for non-LLNA method:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report):ethyl acetate
- Molecular formula : C4H8O2
- Molecular weight : 88.11g/mol
- Substance type: Organic
- Physical state: Liquid
Specific details on test material used for the study:
- Name of test material (as cited in study report):ethyl acetate
- Molecular formula : C4H8O2
- Molecular weight : 88.11g/mol
- Substance type: Organic
- Physical state: Liquid

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: BOR: DHPW
Sex:
female
Details on test animals and environmental conditions:
Details on test animal
TEST ANIMALS
- Source: F. Winkelmann, Borchen.
- Age at study initiation: No data available
- Weight at study initiation:
Test group average wt . 328.5g,
Control group average wt . 308.2g.
- Housing: No data available
- Diet (e.g. ad libitum): No data available
- Water (e.g. ad libitum): No data available - Acclimation period: No data available

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%):No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available
IN-LIFE DATES: From: To: No data available

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: Maize germ oil
Concentration / amount:
10%
Route:
epicutaneous, open
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100%
Challenge
No.:
#1
Route:
epicutaneous, open
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100%
No. of animals per dose:
Total :30
Treated group:20
Control group:10
Details on study design:
Details on study design
RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:2
- Exposure period: No data available
- Test groups:20
- Control group:10
- Site: No data available
- Frequency of applications:
- Duration: No data available
- Concentrations: 01ml dose 1)20%
2) undiluted

B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge: No data available
- Exposure period: 48hr
- Test groups:20
- Control group:10
- Site: No data available
- Concentrations: undiluted
- Evaluation (hr after challenge): 24hr
Other : Test area prepared by clipping 6 hours before start of test

Challenge controls:
No data available
Positive control substance(s):
not specified

Study design: in vivo (LLNA)

Statistics:
No data available

Results and discussion

Positive control results:
No data available

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
Not skin sensitizing reaction was observed
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
other: Not Sensitizing
Conclusions:
The skin sensitization study of Ethyl Acetate (141-78-6) was performed by Guinea pig Magnusson-Kligman maximation test was considered to be not skin sensitizing in guinea pig.

Executive summary:

The skin sensitization study of Ethyl Acetate(141-78-6)was performed byGuinea pig Magnusson-Kligman maximation test in 20guinea pigs.. An additional 10 animals served as the control group.In induction phase,1stinduction given using 0.1ml dose of 10% concentration inmaize germ oil by intradermal route while in 2ndinduction done by using undiluted test material by topical application.Freund's Complete Adjuvant (FCA) used in induction phase

 

In challenge phase, undiluted test material was applied topically for 48hr. After 24, no indication of skin sensitization was observed.No effect on body weight were noted .In induction phase, after intracutaneous application clear reddening, swelling and necroses at the injection sites treated with FCA and deionised water (1:1) observed in Test and control animals while only Clear reddening and swelling at the injection sites treated with the 10% product in maize germ oil in Test group and the control with just maize germ oil only showed slight reddening and swelling at the injection sites but Clear reddening and swelling and slight necroses at the injection sites treated with 10% product in a mixture of FCA and maize germ oil, 1:1 in Test group and those treated with FCA and maize germ oil, 1:1 in control group . After patch test with a contact duration of 48h. Inflammation at all the injection sites treated with FCA. 24h after removal of the patch, crust formation at the injection sites observed butno indication of skin sensitization was observed.Hence it is considered that Ethyl Acetate(141-78-6) was not skin sensitizing in guinea pig by Guinea pig Magnusson-Kligman maximation test.