Registration Dossier
Registration Dossier
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EC number: 204-612-0 | CAS number: 123-25-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April - May 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Diethyl succinate
- EC Number:
- 204-612-0
- EC Name:
- Diethyl succinate
- Cas Number:
- 123-25-1
- Molecular formula:
- C8H14O4
- IUPAC Name:
- 1,4-diethyl butanedioate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: EPFS 201
- Expiration date of the lot/batch: 2005-06-30
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelman GmbH, Borchen, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: ca 8 weeks
- Weight at study initiation: 18 - 22 g
- Housing: Individually caged
- Diet (e.g. ad libitum): Commercial rodent diet (Altromin), ad libitum
- Water (e.g. ad libitum): Municipal supply, ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): average 22 deg C
- Humidity (%): average 46.7%
- Photoperiod (hrs dark / hrs light): 12 / 12
- IN-LIFE DATES: From: 2004-04-27 To: 2004-05-04
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 25, 50 and 100%
- No. of animals per dose:
- 5
- Details on study design:
- PRE-SCREEN TESTS:
- Irritation: no
- Systemic toxicity: no
- Ear thickness measurements: within normal range
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: allocated by random assigment
- Criteria used to consider a positive response: 3 fold or greater increase in stimulation index
TREATMENT PREPARATION AND ADMINISTRATION:
- as per OECD methodology - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- 25% HCA resulted in a SI of 5.8
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 0.7
- Test group / Remarks:
- Low dose (25%)
- Parameter:
- SI
- Value:
- 0.5
- Test group / Remarks:
- Mid dose (50%)
- Parameter:
- SI
- Value:
- 0.5
- Test group / Remarks:
- High dose (100%)
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The local lymph node assay (LLNA) indicates that the substance is not a skin sensitiser.
- Executive summary:
Potential dermal sensitisation has been investigated in-vivo using the local lymph node assay (LLNA). There was no indication from the resultant stimulation indices that the substance acts as a sensitiser.
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