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Registration Dossier
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EC number: 943-016-1 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994-12-02 - 1995-03-24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Scientifically valid GLP study on the registered substance itself according to US EPA guideline 81-5.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reaction Products of Diphosphorus Pentaoxide with n-Alcohols, C8-10 (even), salted with Amines, C12-14, Tert-alkyl
- EC Number:
- 943-016-1
- Molecular formula:
- Too complex
- IUPAC Name:
- Reaction Products of Diphosphorus Pentaoxide with n-Alcohols, C8-10 (even), salted with Amines, C12-14, Tert-alkyl
- Test material form:
- other: liquid
- Details on test material:
- - Substance type: pure substance
- Storage condition of test material: 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: Myrtle's Rabbitry, Thompson Station, TN, USA
- Age at study initiation: adult
- Weight at study initiation: approx. 2.0 - 3.5 kg
- Housing: The animals were housed individually in suspended stainless steel cages. All housing and care were based on the standards recommended by the Guide for the Care and Use of Laboratory Animals
- Diet (e.g. ad libitum): Purina Certified Rabbit Chow #5322 was provided ad libitum to the animals throughout the study.
- Water (e.g. ad libitum): Municipal tap water treated by reverse osmosis was available to the animals ad libitum throughout the study.
- Acclimation period: Min. 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 63-70°F (17.2-21.1°C)
- Humidity (%): 30-52%
- Air changes (per hr): 10-12 / h
- Photoperiod (hrs dark / hrs light): 12h / 12h
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 days
- Number of animals:
- 4 males, 2 females
- Details on study design:
- TEST SITE
- Area of exposure:small area of approx. 1 inch x 1 inch
- % coverage: 100%
- Type of wrap if used: The test article was administered under a 1" x 1" square 4 ply gauze patch. The gauze patch was held in contact with the skin at the cut edges with a non-irritating tape. Removal and ingestion of the test article was prevented by placing an elastic wrap over the trunk and test area (semi-occlusive binding). The elastic wrap was then further secured with adhesive tape around the trunk at the cranial and caudal ends.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test article was removed using gauze moistened with Mineral Oil followed by wiping with dry gauze
- Time after start of exposure: 4 h
SCORING SYSTEM
Evaluation of the results will be done according to EEC Criteria, FHSA Criteria, EPA Criteria, DOT criteria, see "Any other information on materials and methods incl. tables" for details and dermal grading system.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Remarks:
- EEC criteria for Erythema
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 2.83
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Irritant - See "Other information on results incl. tables" for details
- Irritation parameter:
- primary dermal irritation index (PDII)
- Remarks:
- EEC Criteria for Erythema
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Irritant - See "Other information on results incl. tables" for details
- Irritation parameter:
- primary dermal irritation index (PDII)
- Remarks:
- EEC Criteria for Edema
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 3.5
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Irritant - See "Other information on results incl. tables" for details
- Irritation parameter:
- primary dermal irritation index (PDII)
- Remarks:
- EEC Criteria for Edema
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 3.16
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Irritant - See "Other information on results incl. tables" for details
- Irritation parameter:
- primary dermal irritation index (PDII)
- Remarks:
- FHSA criteria
- Basis:
- mean
- Score:
- 6.25
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Irritant - See "Other information on results incl. tables" for details
- Irritation parameter:
- primary dermal irritation index (PDII)
- Remarks:
- EPA criteria
- Basis:
- mean
- Score:
- 5.29
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Severe irritant - See "Other information on results incl. tables" for details
- Irritation parameter:
- other: DOT criteria
- Basis:
- mean
- Reversibility:
- other: not applicable
- Remarks on result:
- other: not corrosive
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- Exposure to the test article produced very slight to well-defined erythema on 6/6 test sites and very slight edema on 5/6 test sites at the 1 hour scoring interval which progressed to focal/pinpoint to mild blanching on 3/6 test sites by the 48 hour scoring. The dermal irritation generally diminished during the remainder of the test period and resolved completely in all animals by study day 14. Additional dermal findings noted during the period included desquamation which was noted on 6/6 test sites.
Any other information on results incl. tables
Table 9: Individual dermal irritation scores
Animal No. / Sex |
Scoring interval |
Erythema |
Edema |
Comments (see table 3&4 for key to codes) |
51721/F |
1h |
2 |
1 |
|
24h |
3 |
4 |
|
|
48h |
4 |
4 |
BLA-2 |
|
72h |
4 |
4 |
BLA-2 |
|
7d |
2 |
0 |
DES |
|
10d |
1 |
0 |
DES |
|
14d |
0 |
0 |
|
|
51748/F |
1h |
1 |
1 |
|
24h |
2 |
2 |
|
|
48h |
2 |
2 |
|
|
72h |
2 |
1 |
|
|
7d |
1 |
0 |
DES |
|
10d |
0 |
0 |
DES |
|
51771/M |
1h |
1 |
1 |
|
24h |
3 |
4 |
|
|
48h |
2 |
3 |
|
|
72h |
2 |
2 |
|
|
7d |
1 |
0 |
DES |
|
10d |
0 |
0 |
DES |
|
51772/M |
1h |
1 |
1 |
|
24h |
3 |
4 |
BLA-1 |
|
48h |
3 |
4 |
BLA-1 |
|
72h |
4 |
4 |
BLA-2 |
|
7d |
2 |
0 |
DES |
|
10d |
1 |
0 |
DES |
|
14d |
0 |
0 |
|
|
51775/M |
1h |
1 |
0 |
|
24h |
2 |
3 |
|
|
48h |
3 |
1 |
|
|
72h |
2 |
1 |
|
|
7d |
1 |
0 |
DES |
|
10d |
0 |
0 |
DES |
|
14d |
0 |
0 |
DES |
|
51749/M |
1h |
2 |
1 |
|
24h |
4 |
4 |
BLA-2 |
|
48h |
4 |
4 |
BLA-2 |
|
72h |
4 |
4 |
BLA-2 |
|
7d |
1 |
0 |
DES |
|
10d |
1 |
0 |
DES |
|
14d |
0 |
0 |
DES |
Table 10: Individual Secondary Dermal Observations (Positive Findings)
Group |
Animal No. / Sex |
Secondary Dermal Observations |
Intact |
51721/F |
Ancillary Irritation on the Trunk Outside the Test Site (IT): 24h, 48h, 72h, 7d, 10d |
Intact |
51748/F |
IT: 1h, 24h, 48h, 72h, 7d, 10d |
Intact |
51771/M |
IT: 1h, 24h, 48h, 72h |
Intact |
51771/M |
IT: 1h, 24h, 48h, 72h, 7d, 10d |
Intact |
51775/M |
IT: 1h, 24h, 48h, 72h |
Intact |
51749/M |
IT: 1h, 24h, 48h, 72h, 7d, 10d |
Table 11: Individual Body weights
Animal No. / Sex |
Body Weight (kg) |
|
Day 0 |
Terminal |
|
51721/F |
2.531 |
2.917 |
51748/F |
2.529 |
3.035 |
51771/M |
2.324 |
2.906 |
51771/M |
2.486 |
2.889 |
51775/M |
2.482 |
2.946 |
51749/M |
2.338 |
2.898 |
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The study is well-documented and was performed according to EPA OPP 81-5 (Acute Dermal Irritation), under GLP conditions. Hence, the information provided in the report can be considered reliable. In consequence, the results are suitable for the assessment of the acute dermal irritation potential of the test item. Under the conditions of this test, the test item was determined to be an irritant.
- Executive summary:
In a primary dermal irritation study (EPA OPP 81-5), young adult New Zealand White rabbits (2 females, 4 males) were dermally exposed to 0.5 ml of the undiluted test item for four hours to an area of approx. 1 inch². Animals then were observed for 14 days.
Exposure to the test article produced very slight to well-defined erythema on 6/6 test sites and very slight edema on 5/6 test sites at the 1 hour scoring interval which progressed to focal/pinpoint to mild blanching on 3/6 test sites by the 48 hour scoring. The dermal irritation generally diminished during the remainder of the test period and resolved completely in all animals by study day 14. Additional dermal findings noted during the period included desquamation which was noted on 6/6 test sites.
In this study, the undiluted test item is a dermal irritant.
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