Registration Dossier
Registration Dossier
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EC number: 600-768-2 | CAS number: 106726-11-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 25 Nov 1998 to 14 Jan 2000
- Rationale for reliability incl. deficiencies:
- other: Non GLP screening study comparable to guideline study, but limited number of animals was used and no positive control performed. Housing conditions were missing in the report
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- 5 animals in the treatment group and 3 in the control group instead of at least 10 and 5 respectively. No positive control performed
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- neodymium(3+) 2-ethyl-2,5-dimethylhexanoic acid tris(2-ethyl-2,5-dimethylhexanoate)
- EC Number:
- 600-768-2
- Cas Number:
- 106726-11-8
- Molecular formula:
- C30H57NdO6
- IUPAC Name:
- neodymium(3+) 2-ethyl-2,5-dimethylhexanoic acid tris(2-ethyl-2,5-dimethylhexanoate)
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Neodymium versatate
- Physical state: Blue powder
- Storage condition of test material: Ambient conditions
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- not specified
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Nossan S.r.l., Italy
- Age at study initiation: no data
- Weight at study initiation:
control group :494 +/- 45 g ; treated group: 515 +/- 34 g
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
no data
IN-LIFE DATES: From: To: No data
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- corn oil
- Concentration / amount:
- Intradermal induction injections:
Freunds complete adjuvant (FCA) emulsion (both groups)
Test substance at a concentration of 0.5 % in corn oil (treated group) and corn oil vehicle alone (control group)
Test substance at the concentration of 0.5% in Freunds complete adjuvant (FCA) emulsion (treated group) or Freunds complete adjuvant (FCA) emulsion (control group)
Topical induction:
75% of the test substance in corn oil vehicle. The injection sites have been pre-treated with sodium lauryl sulphate to promote an irritant reaction
Challenge dosing:
10 % test substance in corn oil vehicle
Challengeopen allclose all
- Route:
- other: epicutaneous/ no indication on the type of coverage
- Vehicle:
- corn oil
- Concentration / amount:
- Intradermal induction injections:
Freunds complete adjuvant (FCA) emulsion (both groups)
Test substance at a concentration of 0.5 % in corn oil (treated group) and corn oil vehicle alone (control group)
Test substance at the concentration of 0.5% in Freunds complete adjuvant (FCA) emulsion (treated group) or Freunds complete adjuvant (FCA) emulsion (control group)
Topical induction:
75% of the test substance in corn oil vehicle. The injection sites have been pre-treated with sodium lauryl sulphate to promote an irritant reaction
Challenge dosing:
10 % test substance in corn oil vehicle
- No. of animals per dose:
- Test substance group: 5 animals
Vehicle control group: 3 animals - Details on study design:
- RANGE FINDING TESTS:
The concentrations of the test substanceto be tested in the main study were determined by preliminary screening tests in which no irritation was evident by intradermal injection at0.5 % in corn oil (the highest injectable concentration), and a slight irritation (score of 1) was observed after topical application at a concentration of 75%
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Intradermal injection single exposure. Cutaneous single application one week later.
- Exposure period: no data
- Test groups: test animals were intradermally injected with an emulsion of Freund's complete adjuvant and the test substance in both the selected vehicle and an emulsion of Freund's complete adjuvant. One week later this was boosted by topical application of the test substance over the injection sites which had been pre-treated with sodium lauryl sulphate to promote an irritant reaction
- Control group: control group animals were treated in the same manner but the selected vehicle was used in place of the test substance
- Site: no data
- Frequency of applications: Intradermal injections on day 1 followed by cutaneous application one week later
- Duration: no data
- Concentrations: On day 1, intradermal injections were performed in all animals as follows:
• Freund's complete adjuvant (FCA) emulsion (both groups),
• test item at the concentration of 0.5% in corn oil (treated group) or vehicle alone (control group),
• test item at the concentration of 0.5% in Freund's complete adjuvant (FCA) emulsion (treated group) or vehicle in Freund's complete adjuvant (FCA)
One week later, the animals of the treated group received a topical application of the test item at the concentration of 75% in corn oil (pre-treatment with sodium lauryl sulphate was necessary as the substance was not irritant). The animals of the control group received an application of the vehicle under the same experimental conditions.
B. CHALLENGE EXPOSURE
- No. of exposures: Two weeks after the second induction stage, all animals were challenged by topical application of both the vehicle and the test substance
- Day(s) of challenge: Day 22
- Exposure period: no data
- Test groups: the animals of the treated group were challenged by a topical application of the test item at the concentration of 10 % in corn oil
- Control group: control group animals were treated in the same manner but the selected vehicle was used in place of the test substance
- Site: no data
- Concentrations: 10 % in corn oil
- Evaluation (hr after challenge): 24 and 48 hours after removal of the challenge application - Positive control substance(s):
- no
Results and discussion
- Positive control results:
- No positive control performed
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Corn oil intradermal and epicutaneous
- No. with + reactions:
- 0
- Total no. in group:
- 3
- Clinical observations:
- no data
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: Corn oil intradermal and epicutaneous. No with. + reactions: 0.0. Total no. in groups: 3.0. Clinical observations: no data.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Corn oil intradermal and epicutaneous
- No. with + reactions:
- 0
- Total no. in group:
- 3
- Clinical observations:
- no data
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: Corn oil intradermal and epicutaneous. No with. + reactions: 0.0. Total no. in groups: 3.0. Clinical observations: no data.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1 % intradermal and 75 % epicutaneous
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no data
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1 % intradermal and 75 % epicutaneous. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no data.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1 % intradermal and 75 % epicutaneous
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no data
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.1 % intradermal and 75 % epicutaneous. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no data.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the experimental conditions of the test, the test substance Neodymium versatate did not induce delayed dermal sensitisation in guinea pigs.
- Executive summary:
The potential of the test item Neodymium Versatate to induce delayed dermal sensitisation was evaluated in guinea pigs according to the maximization method of Magnusson and Kligman.
Method
Eight guinea pigs were allocated to two groups: a control group of three animals and a treated group of five animals. On day 1, intradermal injections were performed in all animals as follows:
- Freund's complete adjuvant (FCA) emulsion (both groups),
- test item at the concentration of 0.5% in corn oil (treated group) or vehicle alone (control group),
- test item at the concentration of 0.5% in Freund's complete adjuvant (FCA) emulsion (treated group) or vehicle in Freund's complete adjuvant (FCA).
One week later the skin was treated topically with 75% of the test item in corn oil. On day 22, all animals of both groups were challenged by a cutaneous application of the test item at the concentration of 10% in corn oil. Skin reactions were evaluated approximately 24 and 48 hours after the challenge application removal.
No further details on the procedure were reported (no data on the dressing type and the duration of contact).
Results
The results of this study indicated that the test substance did not elicit a sensitisation response in the guinea pig, there being no evidence of reaction at challenge following a period of induction exposure to the substance.
Conclusion
Under the experimental conditions and according to the maximization method of Magnusson and Kligman, test substance Neodymium Versatate did not not induce delayed dermal sensitisation in guinea pigs.
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