Registration Dossier
Registration Dossier
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EC number: 203-419-9 | CAS number: 106-65-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- July 1990 - February 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
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:
- Dimethyl succinate
- EC Number:
- 203-419-9
- EC Name:
- Dimethyl succinate
- Cas Number:
- 106-65-0
- Molecular formula:
- C6H10O4
- IUPAC Name:
- dimethyl succinate
- Details on test material:
- - Name of test material (as cited in study report): Bernsteinsauredimethylester
- Analytical purity: 99.7%
- Purity test date: 1991-01-21
- Lot/batch No.: OP.15 vom 07.05.90
- Stability under test conditions: Stable
- Storage condition of test material: 4 deg C, protected from light
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Kastengrund
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 3.0 - 4.2 kg
- Housing: Metal cages
- Diet (e.g. ad libitum): Altromin 2123 rabbit diet, ad-libitum
- Water (e.g. ad libitum): Deionised water, ad-libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23 deg C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark
IN-LIFE DATES: From: 1990-07-24 To: 1990-07-27
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 100% (undiluted) - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5x2.5 cm square
- % coverage: 100% over stated area
- Type of wrap if used: Fabric wound plaster held in place by semi-occlusive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual material removed with lukewarm tap water
- Time after start of exposure: 4 hours
SCORING SYSTEM: According to Draize et.al as described in OECD test guideline
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritant / corrosive response data:
- None observed
- Other effects:
- None observed
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not irritating to the skin
- Executive summary:
Potential irritation / corrosion following a single application to the intact skin of rabbits has been investigated. Methods followed those described by OECD Test Guideline No. 404 and EC Directive 84/449/EEC, B.4. A 0.5 mL aliquot of the substance was applied to a site of approximately 2.5 cm x 2.5 cm area of intact skin on each of 3 rabbits and covered by semi-occlusive dressing. The duration of the exposure was 4 hours. The treated skin was examined: 0.5-1, 24, 48 and 72 hours after exposure for evidence of reaction to treatment.
No effects of treatment were observed.
The substance is not irritating to the skin
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