Registration Dossier
Registration Dossier
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EC number: 204-685-9 | CAS number: 124-17-4
Skin sensitisation
Administrative data
- 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.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Adequate in vivo (Buhler study) already available.
Test material
- Reference substance name:
- 2-(2-butoxyethoxy)ethyl acetate
- EC Number:
- 204-685-9
- EC Name:
- 2-(2-butoxyethoxy)ethyl acetate
- Cas Number:
- 124-17-4
- Molecular formula:
- C10H20O4
- IUPAC Name:
- 2-(2-butoxyethoxy)ethyl acetate
- Details on test material:
- - Name of test material (as cited in study report): Butyldiglycolacetat, 2-(2-butoxyethoxy)ethyl acetate
- Physical state: colourless liquid
- Analytical purity: 98,4 mass%
- Lot/batch No.: Beh. 6
Constituent 1
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. - Challenge controls:
- no data
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 30
- Group:
- test chemical
- 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 chemical
- 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 chemical
- 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 chemical
- 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 -(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
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