Registration Dossier
Registration Dossier
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EC number: 204-800-2 | CAS number: 126-73-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Reference Type:
- publication
- Title:
- Acute Toxicologic Evaluation of Tri-n-butylphosphate
- Author:
- Bomhard E, Pauluhn J, Ruf J
- Year:
- 2 000
- Bibliographic source:
- Int J Toxicol 19, 338
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Tributyl phosphate
- EC Number:
- 204-800-2
- EC Name:
- Tributyl phosphate
- Cas Number:
- 126-73-8
- Molecular formula:
- C12H27O4P
- IUPAC Name:
- tributyl phosphate
- Details on test material:
- Purity: 99,80 %
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Interfauna UK ltd
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +- 2
- Humidity (%): 45 - 65
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: 1986
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: the liquid test item was applied pure
- Controls:
- other: Test animals served also as control
- Amount / concentration applied:
- 500 µl
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 d
- Number of animals:
- 4 female; 2 male rabbits
- Details on study design:
- test areas were washed with water after removing the patch
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: enduration
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: enduration
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of mild irritation
- Irritant / corrosive response data:
- please see table with further animals
Any other information on results incl. tables
Skin Irritation/corrosion (Exposure time 4h):
| Animal No: | Body weight (sex) | DRAIZE Grade after | Irritation Values | ||||||||||||||
| 1h | 1h | 24h | 24h | 48h | 48h | 72h | 72h | 7d | 7d | 14d | 14d | ||||||
| E12 | 3,5 kg (female) | 1 | 0 | 1 | 2 | 1 | 2 | 4 | 2 | 4 | 4 | 4 | 4 | 2,0 | 2,0 | ||
| E13 | 3,7 kg (female) | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1,0 | 0,0 | ||
| C19 | 3,6 kg (female) | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 1,0 | 0,0 | ||
| G88 | 3,1 kg (male) |
1 | 0 | 2 | 0 | 3 | 0 | 3 | 0 | 2 | 0 | 0 | 0 | 2,7 | 0,0 | ||
| G89 | 3,4 kg (male) | 1 | 0 | 2 | 1 | 2 | 1 | 3 | 1 | 1 | 0 | 0 | 0 | 2,3 | 1,0 | ||
| F94 | 3,8 kg (female) | 1 | 0 | 2 | 1 | 2 | 1 | 2 | 1 | 1 | 0 | 0 | 0 | 2,0 | 1,0 | ||
| E | Ö | E | Ö | E | Ö | E | Ö | E | Ö | E | Ö | E | Ö | ||||
E= Erythema
Ö= Edema
Media value for erythema: 1,8 (1=slight reddening; 2= good visible reddening)
Media value for edema: 0,7 (1= very slight swelling, nearly not to see)
1,0 up to 1,99 = slight primary irritating
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Executive summary:
The test substance was tested in a 4 h skin irritation/corrosion test in rabbits.
The test substance (500 µl) was administered via patch to the radded skin of one flank and remained there for 4 hours. The other flank served as control and was treated only with water.
The animals were observed for 14 days after experiment. In 2 of 6 animals the effects were not reversible within a period of 14 days. Mean value for erythema after DRAIZE-grade was: 1.8; mean value for edema: 0.7
The test substance was found to be irritating.
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