Registration Dossier
Registration Dossier
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EC number: 204-612-0 | CAS number: 123-25-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
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: EMLS 201
- Expiration date of the lot/batch: June 1999
- Purity: >= 99%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Refrigerated, in the dark
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: None
FORM AS APPLIED IN THE TEST
- As supplied
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: J. Schitkovits, A-2620 Natschbach
- Weight at study initiation: 2.6 - 3.1 kg
- Housing: Individually caged in metal wire cages
- Diet: Altromin 2023, ad libitum
- Water: Municipal tap water, ad libitum
- Acclimation period: 11 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Avergae 20 deg C
- Humidity (%): Average 54%
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1999-04-27 To: 1999-04-30
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): Undiluted (100%)
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: Cellulose patches held in place by non-irritating tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Treated sites cleansed with wet Kleenex tissues
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
- 1, 24, 48 and 72 hours after patch removal
SCORING SYSTEM:
- Draize scale
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- No irritant response observed in any animal at any time point
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Diethyl succinate was found not to be a skin irritant on in-vivo testing
- Executive summary:
Skin irritaion has been assessed in-vivo following OECD/EU test methods. Diethyl succinate elicited no response following exposure and is regarded as being non-irritant to the skin.
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