Registration Dossier
Registration Dossier
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EC number: 907-578-1 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study is carried out in accordance to OECD guideline 429, EU method B.42 and is GLP compliant. Therefore, it is given reliability rating of 1 (reliable without restrictions).
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study is carried out in accordance to OECD guideline 429, EU method B.42 and is GLP compliant. Therefore, it is given reliability rating of 1 (reliable without restrictions).
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'. - Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- other: Local Lymph Node Assay
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: Approximately 10 weeks old
- Weight at study initiation: Body weight variation was within +/- 20% of the sex mean.
- Housing: Makrolon cages containing sterilised sawdust
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24
- Humidity (%): 40-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 2, 15 and 30 % test item w/w
- No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS: 15 and 30 % test item w/w using 2 animals per concentration
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 days
- Test groups: 5 animals exposed to each concentration
- Control group: 5 animals exposed to the vehicle
- Site: dorsal surface of both ears
- Frequency of applications: Days 1, 2, 3
- Duration: 6 days
- Concentrations: 2, 15 and 30 % test item w/w
SCORE:
Erythema and eschar formation:
No erythema ..............................................................................……………….....................……………………….. 0
Very slight erythema (barely perceptible) ..............................................................……………………………… 1
Well-defined erythema ...................................................................……………………....................……………… 2
Moderate to severe erythema (beet redness) to slight eschar formation (injuries in depth) .........……… 3
Severe erythema (beet redness) to eschar formation preventing grading of erythema .................……… 4 - Positive control substance(s):
- not specified
- Parameter:
- other: Migrated information from in vivo LLNA study
- Remarks on result:
- other: Reading: other: All readings. Group: test group. Dose level: 2, 15% and 30%. No with. + reactions: 0.0. Total no. in groups: 15.0. Clinical observations: None.
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- dose level: 2 % test item w/w
- Parameter:
- SI
- Value:
- 0.9
- Test group / Remarks:
- dose level: 15 % test item w/w
- Parameter:
- SI
- Value:
- 0.6
- Test group / Remarks:
- dose level: 30 % test item w/w
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Conclusions:
- Dilithium adipate would not be regarded as a skin sensitizer.
- Executive summary:
This study is carried out in accordance to OECD guideline 429, EU method B.42 and is GLP compliant. Therefore, it is given reliability rating of 1 (reliable without restrictions). Dilithium adipate would not be regarded as a skin sensitizer.
No irritation and no signs of systemic toxicity were observed in any of the animals.
No mortality occurred and no clinical signs of systemic toxicity were observed in the animals of the main study. Body weights and body weight gain of experimental animals remained in the same range as controls over the study period.
All auricular lymph nodes of the animals of the experimental and control groups were considered normal in size.
No macroscopic abnormalities of the surrounding area were noted for any of the animals.
Mean DPM/animal values for the experimental groups treated with test item concentrations 2, 15 and 30% were 899, 780 and 584 DPM, respectively. The mean DPM/animal value for the vehicle control group was 911 DPM. The SI values calculated for the item concentrations 2, 15 and 30% were 1.0, 0.9 and 0.6, respectively.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- other: Local Lymph Node Assay
Test material
- Reference substance name:
- Dilithium adipate
- EC Number:
- 242-449-7
- EC Name:
- Dilithium adipate
- Cas Number:
- 18621-94-8
- Molecular formula:
- C6H8O4.2Li
- IUPAC Name:
- dilithium adipate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material: dilithium adipate
- Molecular formula: C6H8O4.2Li
- Molecular weight: 158
- Physical state: white powder
- Analytical purity: 100%
- Lot/batch No.: A049/99
- Expiration date of the lot/batch: 6 March 2018
- Storage condition of test material: At room temperature protected from light
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: Approximately 10 weeks old
- Weight at study initiation: Body weight variation was within +/- 20% of the sex mean.
- Housing: Makrolon cages containing sterilised sawdust
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24
- Humidity (%): 40-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 2, 15 and 30 % test item w/w
- No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS: 15 and 30 % test item w/w using 2 animals per concentration
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 days
- Test groups: 5 animals exposed to each concentration
- Control group: 5 animals exposed to the vehicle
- Site: dorsal surface of both ears
- Frequency of applications: Days 1, 2, 3
- Duration: 6 days
- Concentrations: 2, 15 and 30 % test item w/w
SCORE:
Erythema and eschar formation:
No erythema ..............................................................................……………….....................……………………….. 0
Very slight erythema (barely perceptible) ..............................................................……………………………… 1
Well-defined erythema ...................................................................……………………....................……………… 2
Moderate to severe erythema (beet redness) to slight eschar formation (injuries in depth) .........……… 3
Severe erythema (beet redness) to eschar formation preventing grading of erythema .................……… 4 - Positive control substance(s):
- not specified
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- other: Migrated information from in vivo LLNA study
- Remarks on result:
- other: All readings. Group: test group. Dose level: 2, 15% and 30%. No with. + reactions: 0.0. Total no. in groups: 15.0. Clinical observations: None.
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- dose level: 2 % test item w/w
- Parameter:
- SI
- Value:
- 0.9
- Test group / Remarks:
- dose level: 15 % test item w/w
- Parameter:
- SI
- Value:
- 0.6
- Test group / Remarks:
- dose level: 30 % test item w/w
Any other information on results incl. tables
No irritation and no signs of systemic toxicity were observed in any of the animals.
No mortality occurred and no clinical signs of systemic toxicity were observed in the animals of the main study. Body weights and body weight gain of experimental animals remained in the same range as controls over the study period.
All auricular lymph nodes of the animals of the experimental and control groups were considered normal in size.
No macroscopic abnormalities of the surrounding area were noted for any of the animals.
Mean DPM/animal values for the experimental groups treated with test item concentrations 2, 15 and 30% were 899, 780 and 584 DPM, respectively. The mean DPM/animal value for the vehicle control group was 911 DPM. The SI values calculated for the item concentrations 2, 15 and 30% were 1.0, 0.9 and 0.6, respectively.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Conclusions:
- Dilithium adipate would not be regarded as a skin sensitizer.
- Executive summary:
This study is carried out in accordance to OECD guideline 429, EU method B.42 and is GLP compliant. Therefore, it is given reliability rating of 1 (reliable without restrictions). Dilithium adipate would not be regarded as a skin sensitizer.
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