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EC number: 204-800-2 | CAS number: 126-73-8
Endpoint summary
Administrative data
Description of key information
In 2 guideline studies tributyl phosphate was tested on rabbits for skin irritation/corrosion and eye irritation. The test substance was found to be irritating to skin and slightly irritating to eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- not specified
- 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 - 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
- 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
- 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.
Reference
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
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye 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:
- other: No GLP defined.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues 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 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The test animals served also as control ( the other eye was not treated)
- Amount / concentration applied:
- 100 µl
- Duration of treatment / exposure:
- single application; the eye lids were hold together for 1 second; the eye was rinsed with saline 24 h after treatment
- Observation period (in vivo):
- 21 d
- Number of animals or in vitro replicates:
- 3 female rabbits
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 3 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritant / corrosive response data:
- slightly irritating to the eyes
- Interpretation of results:
- GHS criteria not met
- Remarks:
- slightly irritating
- Executive summary:
The test substance was tested in a 24 h eye irritation test in rabbits.
The test substance (100 µl) was administered into one eye of 3 rabbits (the other eye remained untreated and served as control). The substance was washed out after 24 hours with NaCl.
The animals were observed for 21 days after experiment.
The test substance was found to be slightly irritating to eye.
Reference
Irritation in eye:
| Animal Nr., sex (body weight) | examined organ | Symptoms | DRAIZE-Grade after | Irritation Value | ||||||
| 1h* | 24h | 48h | 72h | 7d | 14d | 21d | ||||
| E14, female (3,1 kg) | opacity of cornea | 1 | 1 | 1 | 0 | 0 | 0 | - | 0,7 | |
| cornea area | 2 | 1 | 1 | 0 | 0 | 0 | - | |||
| iris | 1 | 0 | 0 | 0 | 0 | 0 | - | 0,0 | ||
| conjunctivae | R | 2 | 2 | 1 | 0 | 0 | 0 | - | 1,0 | |
| S | 2 | 1 | 0 | 0 | 0 | 0 | - | 0,3 | ||
| T | 2 | 0 | 0 | 0 | 0 | 0 | - | |||
| E15, female (3,5 kg) | opacity of cornea | 1 | 1 | 1 | 1 | 0 | 0 | - | 1,0 | |
| cornea area | 3 | 3 | 3 | 3 | 0 | 0 | - | |||
| iris | 1 | 0 | 0 | 0 | 0 | 0 | - | 0,0 | ||
| conjunctivae | R | 2 | 2 | 2 | 2 | 1 | 0 | - | 2,0 | |
| S | 3 | 2 | 1 | 1 | 1 | 0 | - | 1,3 | ||
| T | 2 | 1 | 0 | 0 | 0 | 0 | - | |||
| E17, female (3,1 kg) | opacity of cornea | 0 | 0 | 0 | 0 | 0 | 0 | - | 0,0 | |
| cornea area | 0 | 0 | 0 | 0 | 0 | 0 | - | |||
| iris | 0 | 0 | 0 | 0 | 0 | 0 | - | 0,0 | ||
| conjunctivae | R | 2 | 2 | 1 | 0 | 0 | 0 | - | 1,0 | |
| S | 2 | 0 | 0 | 0 | 0 | 0 | - | 0,0 | ||
| T | 1 | 0 | 0 | 0 | 0 | 0 | - | |||
*= only the values after 24h were taken in consideration!
R = reddening
S = swelling
- = not examined
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
The test substance was tested in a skin irritation/corrosion test in rabbits (OECD TG 404). The test substance (500 µl) was administered via patch to the shaved skin of one flank and remained there for 4 hours under semi-occlusive conditions. The other flank served as control and was treated only with water.
The animals were observed for 14 days after experiment. Mean value for erythema after DRAIZE-grade was: 1.8; mean value for edema: 0.7. In two of six treated animals the effects were not reversible within the observation time of 14 days. The test substance was thus found to be irritating to skin.
The test substance was tested in a 24 h eye irritation test in rabbits (OECD TG 405). The test substance (100 µl) was administered into one eye of 3 rabbits (the other eye remained untreated and served as control). The substance was washed out after 24 hours with NaCl. The animals were observed for 21 days after experiment.
The test substance was found to be slightly irritating to eyes.
Justification for classification or non-classification
Based on a skin irritation study on rabbits (OECD TG 404) with a mean value for erythema of 1.8, and a mean value for oedema of 0.7 the test item can be considered as slightly irritating to skin. However, since 2 of 6 animals showed irreversibility of effects the substance should be considered as eye irritant and classified accordingly with Skin Irrit 2 (H315).
On the basis of an eye irritation study on rabbits (OECD TG 405) showing slight irritating effects, a classification for eye irritation is not justified.
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