Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
17.081998-16.10.1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Valid study to GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of study:
Buehler test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Butylglycolacetat, 2-butoxyethyl acetate
- Physical state: colourless liquid
- Analytical purity: 99,1 mass-%
- Lot/batch No.: Beh. 11

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Dunkin Hartley, Pirbright White Hsd/Poc:DH [SPF]
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Versuchstierzucht, Gartenstr. 27, 33176 Borchen, Germany
- Weight at study initiation: <500 g
- Housing: conventional, max. 5 animals/macrolon cage Type IV
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: min. 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12


IN-LIFE DATES: From: To:

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
For induction phase and challenge treatment the undiluted substance was used. During challenge treatment corn oil was used as control additionally in the control group as well as in the test group.
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
For induction phase and challenge treatment the undiluted substance was used. During challenge treatment corn oil was used as control additionally in the control group as well as in the test group.
No. of animals per dose:
prelimanary group: 3 animals
Test group: 20 animals
Control group: 10 animals
Details on study design:
RANGE FINDING TESTS:
3 animals, 5, 25, 50 and 100% w/w test substance in corn oil, each.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hrs
- Test groups: butyldiglycol acetate
- Control group: corn oil
- Site: left flank
- Frequency of applications: 3 (days 0, 7, 14)
- Duration: 6 hrs/each
- Concentrations: undiluted

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 28
- Exposure period: 6 hrs
- Test groups: butyldiglycol acetate
- Control group: corn oil
- Site: right flank
- Concentrations: vehicle (corn oil)
- Evaluation (hr after challenge): 30 and 54 hrs


OTHER: The animals in the test group and the control group were challanged with the test substance at the rear of the right flank. Additionally they were challenged with the vehicle at the front of the right flank.

In a separate study (HS-98/alpha-HCA-1) the sensitivity of the guinea pig strain was checked using the standard allergen alpha-hexylcinnamaldehyde .The Magnusson and Kligman maximization method was carried out for this test. A test group of 10 and a control group of 5 animals were used. 48 and 72 hrs after challenge treatment all skin reactions were recorded.
The standard allergen had no systemic effects and did not impair body weight gain in either the test animals or the control animals during the investigation.
The challenge treatment with the 100 % standard allergen did cause cutaneous reactions on the right flank of 5 animals in the test group 48 hrs after administration. 72 hrs later 4 animals still showed irritations on the treated skin. 5 test and all animals of the control group did not show any skin reactions after 48 and 72 hrs. Neither did the vehicle laden patch on the left flank lead to skin reactions in any animal of the test and control groups.

On the basis of these results (50% of the test animals showed evidence of delayed contact hypersensitivity), the guinea pig strain is judged to be sensitive und the test consitions described. In the maximisation method, a figure of 30 % or more is regarded as a positive test result.
Challenge controls:
no data
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
30
Group:
test group
Dose level:
undiluted test substance
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 30.0. Group: test group. Dose level: undiluted test substance. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
30
Group:
test group
Dose level:
vehicle
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 30.0. Group: test group. Dose level: vehicle. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
54
Group:
test group
Dose level:
undiluted test substance
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 54.0. Group: test group. Dose level: undiluted test substance. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
54
Group:
test group
Dose level:
vehicle
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 54.0. Group: test group. Dose level: vehicle. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
30
Group:
negative control
Dose level:
unduluted test substance
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 30.0. Group: negative control. Dose level: unduluted test substance. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
30
Group:
negative control
Dose level:
vehicle
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 30.0. Group: negative control. Dose level: vehicle. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
54
Group:
negative control
Dose level:
undiluted test substance
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 54.0. Group: negative control. Dose level: undiluted test substance. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
54
Group:
negative control
Dose level:
vehicle
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 54.0. Group: negative control. Dose level: vehicle. No with. + reactions: 0.0. Total no. in groups: 10.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Executive summary:

A GLP guideline Buehler sensitisation study was performed on guinea pigs using 2 -butoxyethyl acetate as the test substance. Induction was carried out using three 6 hour exposures over a period of two weeks, with a single challenge carried out after a further two weeks. No irritation was noted after the induction exposures and no sensitisation reaction was noted after the challenge exposure at either of the two observation times.

Synopsis

Negative for sensitisation