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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
Reference
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

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

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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
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

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

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.

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.