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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1969
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted prior to GLP and test guidelines and the report contains sufficient data for interpretation of study results the test substance purity is unknown.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1969
Report date:
1969

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
To test for the primary irritation potential of tritolyl phosphite the test material was applied to the shaved intact shoulder skin of ten male albino guinea pigs. Irritation wasa recorded on day 1, day 2, and day 3 after exposure initiation.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Tris(methylphenyl) phosphite
EC Number:
247-119-6
EC Name:
Tris(methylphenyl) phosphite
Cas Number:
25586-42-9
Molecular formula:
C21H21O3P
IUPAC Name:
tris(methylphenyl) phosphite
Details on test material:
- Name of test material (as cited in study report): Tritolyl phosphite
- Impurities (identity and concentrations): traces of cresols and phosphorus trichloride

Test animals

Species:
guinea pig
Strain:
not specified
Details on test animals or test system and environmental conditions:
Data not available

Test system

Type of coverage:
not specified
Preparation of test site:
shaved
Vehicle:
not specified
Controls:
no
Amount / concentration applied:
0.05 ml of undiluted material; 25%, 10%, 5%, and 1% test material in DMP
Duration of treatment / exposure:
not given
Observation period:
3 days
Number of animals:
10
Details on study design:
TEST SITE
- Area of exposure: shaevd intact shoulder skin
- % coverage: 3-5 cm x 4-6 cm

SCORING SYSTEM: Neg = negative, + = mild, ++ = moderate, +++ = strong erthyema, ++++ = erythema with edema

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 10 out of 10 animals
Time point:
other: 24 hours after initiation
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 24 hours
Remarks on result:
other: undiluted test material on intact skin
Irritation parameter:
erythema score
Basis:
animal: 2 out of 10 animals
Time point:
other: 48 hours after initiation
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 24 hours
Remarks on result:
other: undiluted test material on intact skin
Irritation parameter:
erythema score
Basis:
animal: 8 out of 10 animals
Time point:
other: 48 hours after initiation
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 24 hours
Remarks on result:
other: undiluted test material on intact skin
Irritation parameter:
erythema score
Basis:
animal: 10 out of 10 animals
Time point:
other: 72 hours after initiation
Score:
4
Max. score:
4
Reversibility:
no data
Remarks on result:
other: undiluted test material on intact skin
Irritation parameter:
erythema score
Basis:
animal: 10 out of 10 animals
Time point:
other: 24 hours after initiation
Score:
0
Max. score:
4
Reversibility:
no data
Remarks on result:
other: 25% test material on intact skin
Irritation parameter:
erythema score
Basis:
animal: 10 out of 10 animals
Time point:
other: 48 hours after initiation
Score:
0
Max. score:
4
Reversibility:
no data
Remarks on result:
other: 25 % test material on intact skin
Irritation parameter:
erythema score
Basis:
animal: 10 out of 10 animals
Time point:
other: 24 hours after initiation
Score:
0
Max. score:
4
Reversibility:
no data
Remarks on result:
other: 10% test material on intact skin
Irritation parameter:
erythema score
Basis:
animal: 10 out of 10 animals
Time point:
other: 48 hours after initiation
Score:
0
Max. score:
4
Reversibility:
no data
Remarks on result:
other: 10% test material on intact skin
Irritation parameter:
erythema score
Basis:
animal: 5 out of 10 animals
Time point:
other: 24 hours after initiation
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: 5% test material on intact skin
Irritation parameter:
erythema score
Basis:
animal: 5 out of 10 animals
Time point:
other: 24 hours after initiation
Score:
0
Max. score:
4
Reversibility:
no data
Remarks on result:
other: 5% test material on intact skin
Irritation parameter:
erythema score
Basis:
animal: 10 out of 10 animals
Time point:
other: 48 hours after initiation
Score:
0
Max. score:
4
Reversibility:
no data
Remarks on result:
other: 5% test material on intact skin
Irritation parameter:
erythema score
Basis:
animal: 3 out of 10 animals
Time point:
other: 24 hours after initiation
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: 1% test material on intact skin
Irritation parameter:
erythema score
Basis:
animal: 7 out of 10 animals
Time point:
other: 24 hours after initiation
Score:
0
Max. score:
4
Reversibility:
no data
Remarks on result:
other: 1% test material on intact skin
Irritation parameter:
erythema score
Basis:
animal: 10 out of 10 animals
Time point:
other: 48 hours after initiation
Score:
0
Max. score:
4
Reversibility:
no data
Remarks on result:
other: 1% test material on intact skin

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

Undiluted tritolyl phosphite produced somewhat delayed, but strong, flaring, and prolonged primary irritation of guinea pig skin. On the basis of the above data, the increased sensitivity of the skin to further contact would appear to be on a primary irritancy rather than on an allergic basis.

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