Registration Dossier
Registration Dossier
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EC number: 905-983-8 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline study and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Benzyl 2-ethylhexyl adipate
- EC Number:
- 261-234-9
- EC Name:
- Benzyl 2-ethylhexyl adipate
- Cas Number:
- 58394-64-2
- Molecular formula:
- C21H32O4
- IUPAC Name:
- benzyl 2-ethylhexyl adipate
- Reference substance name:
- Bis(2-ethylhexyl) adipate
- EC Number:
- 203-090-1
- EC Name:
- Bis(2-ethylhexyl) adipate
- Cas Number:
- 103-23-1
- Molecular formula:
- C22H42O4
- IUPAC Name:
- bis(2-ethylhexyl) adipate
- Reference substance name:
- Dibenzyl adipate
- EC Number:
- 219-516-4
- EC Name:
- Dibenzyl adipate
- Cas Number:
- 2451-84-5
- Molecular formula:
- C20H22O4
- IUPAC Name:
- dibenzyl adipate
- Test material form:
- liquid
Constituent 1
Constituent 2
1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 3.1 - 3.3 kg
- Housing: individually
- Diet ad libitum
- Water ad libitum
- Acclimation period: at least 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Humidity (%): 50
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 /12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The opposite site of the back served as control.
- Amount / concentration applied:
- 500 µl
- Duration of treatment / exposure:
- 4 h
- Observation period:
- up to 14 days
- Details on study design:
- TEST SITE
- Area of exposure: 6 x 6 cm
- Type of wrap if used: semi-osslusive
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 4 h
SCORING SYSTEM:
according to Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score = 0 at any time points
- Remarks on result:
- not determinable
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score = 0 at any time point
- Remarks on result:
- not determinable
- Irritant / corrosive response data:
- 'Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate' can be regarded as not irritating to the skin.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
A study for irritant / corrosive potential on the rabbit's skin was conducted with 'Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate' in accordance witz the OECD Guideline for testing of chemicals No. 404. Based on the obtained results 'Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate' can be regarded as not irritating to the skin.
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