Registration Dossier
Registration Dossier
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EC number: 413-860-0 | CAS number: 1187-74-2 ACETONYLBERNSTEINSÄUREESTER; ASE
Toxicological information
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant study conducted to international test guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Diethyl 4-oxopentane-1,2-dicarboxylate
- EC Number:
- 413-860-0
- EC Name:
- Diethyl 4-oxopentane-1,2-dicarboxylate
- Cas Number:
- 1187-74-2
- Molecular formula:
- C11H18O5
- IUPAC Name:
- 1,4-diethyl 2-(2-oxopropyl)butanedioate
- Details on test material:
- - Name of test material (as cited in study report): acetonyl succinic acid diethyl ester
- Physical state: Liquid
- Analytical purity: 96.1%
- Lot/batch No.: A548702
- Expiration date of the lot/batch: 1992-05-25
- Stability under test conditions: Stable
- Storage condition of test material: Room temperature, protected from light
:
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Ibm: GOHI
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Biological Research Laboratories Ltd, Wolferstrasse 4, CH-4414, Fullinsdorf
- Age at study initiation: 8 weeks
- Weight at study initiation: 331 - 424 g
- Housing: Individually caged in "Makrolon Type 3" cages (27x42x15 cm) with softwood bedding
- Diet (e.g. ad libitum): Kliba 342 pelleted guinea pig breeding/maintenance diet
- Water (e.g. ad libitum): Municipal supply with weekly supplementation of vitamin C
- Acclimation period: One week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3°C
- Humidity (%): 40-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1991-09-30 To: 1991-10-31
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- petrolatum
- Concentration / amount:
- Induction - Intradermal injection: 5% in petrolatum and 5% in Freund's complete adjuvant (50:50)
Induction - Epicutaneous: 100%
Challenge - Epicutaneous: 100%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- Induction - Intradermal injection: 5% in petrolatum and 5% in Freund's complete adjuvant (50:50)
Induction - Epicutaneous: 100%
Challenge - Epicutaneous: 100%
- No. of animals per dose:
- Test - 20
Control - 10 - Details on study design:
- RANGE FINDING TESTS:
Intradermal injection: 0.1 mL of 1, 3 and 5% concentrations in petrolatum injected into individual sites on the clipped skin of 2 animals. Dermal reaction assessed 24 hours later
Epicutaneous: 2x2 cm patches of filter paper saturated with concentrations of 100, 75, 50 and 25% in petrolatum and applied to the clipped and shaved flanks of each of 4 animals. Dressings removed after 24 hours. Dermal reaction assessed 24 and 48 hours later.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (1 intradermal; 1 epicutaneous)
- Exposure period: 3 weeks (from intradermal injection to challenge)
- Test groups: Emulsified Freund's complete adjuvant; test substance; test substance in emulsified Freund's complete adjuvant
- Control group: Emulsified Freund's complete adjuvant; vehicle alone; emulsified Freund's complete adjuvant
- Site: Intradermal injection - scapular region; epicutaneoius - over injection sites
- Frequency of applications: Once only
- Duration: 48 hours (epicutaneous)
- Concentrations: Intradermal injection - 5%; epicutaneous - 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1
- Exposure period: 24 hours
- Test groups: Test substance and vehicle alone
- Control group: Test substance and vehicle alone
- Site: Left and right flanks
- Concentrations: 100% test substance
- Evaluation (hr after challenge): 24 and 48 hours
OTHER: - Positive control substance(s):
- yes
- Remarks:
- Formaldehyde
Results and discussion
- Positive control results:
- 80% sensitisation rate (8/10 animals)
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 9.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 9.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 9.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 9.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The substance does not cause sensitisation in contact with skin
- Executive summary:
The substance does not cause sensitisation in contact with skin
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