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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No GLP defined.
Cross-reference
Reason / purpose:
reference to same study

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1986
Reference Type:
publication
Title:
Acute Toxicologic Evaluation of Tri-n-butylphosphate
Author:
Bomhard E, Pauluhn J, Ruf J
Year:
2000
Bibliographic source:
Int J Toxicol 19, 338

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity: 99,80 %

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
abraded
Vehicle:
water
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

Results and discussion

In vivo

Resultsopen allclose all
Remarks on result:
other: slightly irritating
Irritation parameter:
other: DRAIZE-Grade
Basis:
mean
Remarks:
6 rabbits
Time point:
other: 14 d
Remarks on result:
other: Mean value for erythema: 1.8; mean value for edema: 0.7

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)  0  1  2  4  4 2,0      2,0
E13 3,7 kg (female)  1  1 1  0  0 0   1,0        0,0
C19 3,6 kg (female)  1 1  0  1  0  1 1   1,0        0,0
G88

3,1 kg (male) 

1  0  2  0 3  0  3  0  2 0 2,7           0,0
 G89 3,4 kg (male)  1  0  2  1 1  3  1  1  0   2,3       1,0
F94  3,8 kg (female)   1  0  2 1  2  1  1 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:
slightly irritating
Remarks:
Migrated information
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. Mean value for erythema after DRAIZE-grade was: 1.8; mean value for edema: 0.7

The test substance was found to be slightly irritating.