Registration Dossier

Administrative data

Description of key information

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:
17.08.1998 to 15.10.1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Valid guideline study to GLP.
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of study:
Buehler test
Justification for non-LLNA method:
Adequate in vivo (Buhler study) already available.
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:
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.
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.
Challenge controls:
no data
Positive control substance(s):
no
Positive control substance(s):
not specified
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.
Interpretation of results:
not sensitising
Remarks:
Migrated information
Executive summary:

A GLP guideline Buehler sensitisation study was performed on guinea pigs using 2 -(2-butoxyethoxy)ethyl 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

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

A GLP guideline Buehler sensitisation study was performed on guinea pigs using 2 -(2-butoxyethoxy)ethyl 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. This study indicates that the substance is not a skin sensitiser.

It should be noted that there is a single case history of a worker exposed to 2 -(2 -butoxyethoxy)ethyl acetate for many years becoming sensitised, but this single reported case, which in any case showed some evidence of recovery, cannot be used to negate the above conclusion of a lack of sensitising potential.


Migrated from Short description of key information:
Not sensitising

Respiratory sensitisation

Endpoint conclusion
Additional information:
Migrated from Short description of key information:
No data available

Justification for classification or non-classification

The data available indicates that 2 -(2 -butoxyethoxy)ethanol does not meet the criteria for classification as a skin sensitiser.