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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Tris(2-ethylhexyl) phosphate
EC Number:
201-116-6
EC Name:
Tris(2-ethylhexyl) phosphate
Cas Number:
78-42-2
Molecular formula:
C24H51O4P
IUPAC Name:
tris(2-ethylhexyl) phosphate
Details on test material:
Chemical name: Trioctyl phosphate

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: rabbits were clipped free of fur from the dorsal flank area using veterinary clippers.
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
72 Female
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7d
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
72 Female
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7d
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
72 Female
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7d
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
78 Male
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7d
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
78 Male
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7d
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
78 Male
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7d
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
85 Female
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7d
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
85 Female
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7d
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
85 Female
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7d
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
72 Female
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
72 Female
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
72 Female
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
78 Male
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7d
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
78 Male
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7d
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
78 Male
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7d
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
85 Female
Time point:
48 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 7d
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
85 Female
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 7d
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
85 Female
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7d
Other effects:
no corrosive effects were observed.

Any other information on results incl. tables

Amgard TOF: Acute Dermal Irritation test in the Rabbit


Individual daily and individual mean scores for dermal irritation following 4 -hour exposure required for EEC Labeling Rehulations:


 























































































         Individual Scores- Rabbit Number and Sex (Bodyweight kg)
 Skin reaction Reading (Hours) 72 Female (2.57) 78 Male (2.64) 85 Female (2.83)
 Erythema/ Eschar Formation 24 2 2 2
  48 2 2 2
  72 2 2 2
 Total  6 6 6
 Mean Score  2.0+ 2.0+ 2.0+
 Oedema Formation 24 2 2 3
  48 2 2 3
  72 2 2 2
 Total  6 6 8
 Mean Score  2.0+ 2.0+ 2.7+

 


+ = positive criterion


Guest

Applicant's summary and conclusion

Executive summary:

The test substance was tested in three New Zealand White rabbits in a skin irritation/corrosion study according to OECD TG 404. A single 4 -hour, semi-occluded application of the test material to the intact skin of three rabits produced well-defined erythema, slight to moderate oedema, crust formation and desquamation. Crust formation or desquamation persisted at the treated skin sites fourteen days after treatment. The test material produced evidence of irritation with severity values below the thresholds defined by CLP for classification. The observed desquamation and crust formation up to the end of the 14 day observation period in the study by Guest (1993) were not consistently observed among the animals in the study and thus do not meet the qualitative criteria defined by CLP for classification. No corrosive effects were noted.