Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1971
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study performed similar to OECD guideline 404, not under GLP, but acceptable basic data.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2-ethylhexyl diphenyl phosphate

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
No data

Test system

Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
No data
Duration of treatment / exposure:
No data
Observation period:
No data
Number of animals:
3
Details on study design:
No data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 hr
Score:
0
Reversibility:
other: not applicable
Remarks on result:
other: scoring method not provided
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 hr
Score:
1.3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: scoring method not provided
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48 hr
Score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: scoring method not available
Remarks:
results per animals not available
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 hr
Score:
2.3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: scoring method not provided
Remarks:
results per animals not available
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 5 days
Score:
0.6
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: scoring method not provided
Remarks:
results per animals not available
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 7 days
Score:
0
Reversibility:
other: not applicable
Remarks on result:
other: scoring method not provided
Remarks:
results per animals not available
Irritant / corrosive response data:
Slightly irritating to rabbit skin

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The reaction of the test material, 2-ethylhexyl diphenyl phosphate, on the skin was reported as slightly irritating. Given the report that only slight irritation was observed for both skin and eye, it is considered that the irritant potential of 2-ethylhexyl diphenyl phosphate may be low and, therefore, in addition, it is considered unlikely that 2-ethylhexyl diphenyl phosphate possesses any corrosive properties.
Executive summary:

In this GLP non-compliant study of skin irritation, three rabbits (strain and sex not reported) were given dermal applications of the test material 2-ethylhexyl diphenyl phosphate. The reaction was reported as slightly irritating. Given the report that only slight irritation was observed for both skin and eye, it is considered that the irritant potential of 2-ethylhexyl diphenyl phosphate may be low and, therefore, in addition, it is considered unlikely that 2-ethylhexyl diphenyl phosphate possesses any corrosive properties.