Registration Dossier
Registration Dossier
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EC number: 217-385-8 | CAS number: 1830-54-2
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:
- 2001
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Dimethyl 3-oxoglutarate
- EC Number:
- 217-385-8
- EC Name:
- Dimethyl 3-oxoglutarate
- Cas Number:
- 1830-54-2
- Molecular formula:
- C7H10O5
- IUPAC Name:
- dimethyl 3-oxoglutarate
- Details on test material:
- Name of test material (as cited in study report): LZ409
- Molecular formula (if other than submission substance):
- Molecular weight (if other than submission substance):
- Smiles notation (if other than submission substance):
- InChl (if other than submission substance):
- Structural formula attached as image file (if other than submission substance):
- Substance type: organic
- Physical state: light yellow liquid
- Analytical purity:
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Isomers composition:
- Purity test date:
- Lot/batch No.:
- Expiration date of the lot/batch:
- Radiochemical purity (if radiolabelling):
- Specific activity (if radiolabelling):
- Locations of the label (if radiolabelling):
- Expiration date of radiochemical substance (if radiolabelling):
- Stability under test conditions: stable
- Storage condition of test material: room temperature
- Other: stored in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: David Hall Limited, Darley Oaks, Newchurch, Burton-on-Trent, Straffordshire
- Age at study initiation: ca. one month old
- Weight at study initiation: 270-389 g
- Housing: aluminium cages with food hooper and a grid floor beneath which was an absorbent paper lined tray
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21
- Humidity (%): 36-67
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 h/12h
IN-LIFE DATES: From: To:
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- maize oil
- Concentration / amount:
- For induction - 5 concentration
75 % for intraderamal injection and 100 % for topical application
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- maize oil
- Concentration / amount:
- For induction - 5 concentration
75 % for intraderamal injection and 100 % for topical application
- No. of animals per dose:
- Dose Ranging
Dose Ranging for Induction - Intradermal injection: 2 animals
Dose ranging for Induction-Topical application: 2 animals
Dose ranging for Challenge- 2 animals
Main Study
Control Group: 5 animals
Test Group: 10 animals - Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 5
- Exposure period: 9 days
- Test groups: 10 animals
- Control group: 5 animals
- Site: 1st
- Frequency of applications: 1st day, 2nd day, 4th day Freud adjuvant and exposure, 7th day
- Duration: 9 days
- Concentrations: 75, 50, 25, 10 % of LZ409, for intradermal injections (0.1 ml)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 16th day
- Exposure period: 1 day
- Test groups: 10 animals
- Control group: 5 animals
- Site: 2nd
- Concentrations: 0.5ml, 100% LZ409
- Evaluation (hr after challenge): 24h, 48 h
OTHER: - Positive control substance(s):
- yes
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- concentrated
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- moderate/confluent or discrete/patchy erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: concentrated. No with. + reactions: 9.0. Total no. in groups: 10.0. Clinical observations: moderate/confluent or discrete/patchy erythema.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no sings
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: vehicle. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no sings.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- concentrated
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- moderate/confluent or discrete/patchy erythema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: concentrated. No with. + reactions: 9.0. Total no. in groups: 10.0. Clinical observations: moderate/confluent or discrete/patchy erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no signs
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: vehicle. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no signs.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the study the substance is considered to be a sensitiser in guinea pigs.
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