Registration Dossier
Registration Dossier
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EC number: 701-435-5 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- PEG-4 Diheptanoate
- Molecular formula:
- UVCB
- IUPAC Name:
- PEG-4 Diheptanoate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Batch P-574B9
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Fab Labs, New City, New York
- Housing: Stainless stell wire bottomed cage
- Diet (e.g. ad libitum): Purina Rabbit Pellets ad libitum
- Water (e.g. ad libitum): ad linitum
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 hour light/dark
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Concentration (if solution): 0.5 % - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 24 and 72 hours
- Number of animals:
- 1
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm
- Type of wrap if used: the entire trunk of the animal was wrapped with a rubberized elastic cloth to retard evaporation and as an aid in maintening test patch position.
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 24 and 72 hours
SCORING SYSTEM:
- Method of calculation: FHSLA 16 CFR 1500.41
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:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- PEG-4 Diheptanoate is considered to be a non primary skin irritant according to the reference.
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