Registration Dossier
Registration Dossier
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EC number: 410-290-4 | CAS number: 80693-00-1 ADK STAB PEP-36
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 8 February 1988 to 20 July 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study in accordance with internationally recognised guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4470 (Acute Dermal Irritation)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3,9-bis(2,6-di-tert-butyl-4-methylphenoxy)-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane
- EC Number:
- 410-290-4
- EC Name:
- 3,9-bis(2,6-di-tert-butyl-4-methylphenoxy)-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane
- Cas Number:
- 80693-00-1
- Molecular formula:
- Hill formula: C35H54O6P2 CAS formula: C35H54O6P2
- IUPAC Name:
- 3,9-bis(2,6-di-tert-butyl-4-methylphenoxy)-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): PEP-36
- Physical state: White powder
- Purity: 100%
- Date of receipt: 18 February 1988
- Storage condition of test material: At room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: young adult
- Weight at study initiation: not reported
- Housing: screen-bottomed cages
- Diet: 120 g per day certified high fibre rabbit diet
- Water: ad libitum
- Acclimation period: 6 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): temperature controlled conditions but value/range not reported
- Humidity (%):humidity controlled conditions but value/range not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 hour light/12 hour dark
IN-LIFE DATES: From: 8 March To: 11 March 1988
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 500 mg moistened with 0.5 ml of tap water
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: dorsal area approximately 6 cm2
- % coverage: not reported
- Type of wrap if used: non-absorbent binder secured with porous tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the test sites were wiped with gauze and tap water to remove any test material residue.
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize technique
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- There was no erythema, edema or any other dermal effects noted at any time during this study.
- Other effects:
- No mortality occurred during the study.
Any other information on results incl. tables
Animal |
Sex |
Observation interval |
|||
30-60 min |
24 h |
48 h |
72 h |
||
Erythema |
|||||
1 |
M |
0 |
0 |
0 |
0 |
2 |
M |
0 |
0 |
0 |
0 |
3 |
M |
0 |
0 |
0 |
0 |
4 |
F |
0 |
0 |
0 |
0 |
5 |
F |
0 |
0 |
0 |
0 |
6 |
F |
0 |
0 |
0 |
0 |
Edema |
|||||
1 |
M |
0 |
0 |
0 |
0 |
2 |
M |
0 |
0 |
0 |
0 |
3 |
M |
0 |
0 |
0 |
0 |
4 |
F |
0 |
0 |
0 |
0 |
5 |
F |
0 |
0 |
0 |
0 |
6 |
F |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- No mortality, erythema, edema or any other dermal effects noted at any time during the study. Based on the results of the study, PEP-36 is not a dermal irritant.
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