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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
Study period:
October 31, 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP study, no specific methodology followed although documented report available.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guidelineopen allclose all
Qualifier:
no guideline followed
Guideline:
other: For skin irritation, essentially the draize method is quoted.
Deviations:
yes
Remarks:
see below
Qualifier:
equivalent or similar to guideline
Guideline:
other: 49 CFR 173.240 (a)(1) for dermal corrosion
Deviations:
yes
Remarks:
see below
Principles of method if other than guideline:
Dermal Irritation.

A group of albino New Zealand rabbits were used in this study. The test method was essentially that of Draize et .al.
Briefly paraphrased, it consisted of application of 0.5 ml (0.5 g) of the test material to clipped areas of intact and abraded skin. The abrasions were longitudinal epidermal incisions sufficiently deep to penetrate the stratum corneum, but not to deep as to destroy the integrity of the derma.
Applications were made under occiusive patches (2" x 2" gauze, covered by adhesive tape). Following application of the test material the entire trunk of each animal was covered with an impermeable occlusive wrapping. The availability of the test site to the animal is restricted by use of Elizabethan collars. The wrapping and test material were removed 24 hours following application. The sites were individually examined and scored separately for erythema and edema at 24 and 72 hours. The mean scores for 24 and 72 hour grading were averaged to determine final irritation indices.

Dermal Corrosion

A group of six (6) albino New Zealand rabbits in a weight range of 1.8 - 2.4 kg, were used in this study. The est method was essentially that of Draize et.al. Briefly paraphrased, it consisted of application of 0.5 ml (0.5 g) of the test material to clipped areas of intact skin. Applications were made under occlusive patches (2" x 2 gauze, covered by adhesive tape). Following application of the test material the entire trunk of each animal was covered with an impermeable occlusive wrapping. The animals were then immobilized.
The wrapping and test material were removed 4 hours following application. The sites were individually examined and scored separately for erythema and edema at 4 and 48 hours. The mean scores for 4 and 48 hour gradings were averaged to determine final irritation indices.
Corrosiveness seen at four and/or 48 hours alone indicates a corrosive material. Tissue destruction (corrosiveness) does not include merely sloughing of the epidermis, or erythema, edema or fissuring.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Kronitex TCP (tricresyl phosphate)
IUPAC Name:
Kronitex TCP (tricresyl phosphate)
Details on test material:
- Name of test material (as cited in study report): Kreonitex TCP (tricresyl phosphate)
- Molecular formula (if other than submission substance): not applicable
- Molecular weight (if other than submission substance): not applicable
- Smiles notation (if other than submission substance): not applicable
- InChl (if other than submission substance): not applicable
- Structural formula attached as image file (if other than submission substance): see Fig. No
- Substance type: Not specified
- Physical state: Not specified
- Analytical purity: Not specified
- Impurities (identity and concentrations): Not specified
- Composition of test material, percentage of components: Not specified
- Isomers composition: Not specified
- Purity test date: Not specified
- Lot/batch No.: Not specified
- Expiration date of the lot/batch: Not specified
- Radiochemical purity (if radiolabelling): not applicable
- Specific activity (if radiolabelling): not applicable
- Locations of the label (if radiolabelling): not applicable
- Expiration date of radiochemical substance (if radiolabelling): not applicable
- Stability under test conditions: not specified
- Storage condition of test material: not specified
- Other:

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
All animals are fed and watered ad libitum; with Wayne animal feeds used exclusively. Animals are received from Summit View Farm, Belvidere, New
Jersey and are conditioned prior to use.

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped, intact and abraded for dermal irritation test, clipped and intact for corrosion test
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml (0.5 g)
Duration of treatment / exposure:
24 hours for irritation test, 4 hours for corrosion test.
Observation period:
72 hours for irritation test, 48 hours for corrosion test
Number of animals:
6 per test
Details on study design:
Primary Dermal Irritation: A group of albino New Zealand rabbits as indicated in the summary were used in this study. The tfst method was essentially that of Draize et .al. Briefly paraphrased, it consisted of application of 0.5 ml (0.5 g) of the test material to clipped areas of intact and abraded skin. The abrasions were longitudinal epidermal incisions sufficiently deep to penetrate the stratum corneum, but not so deep as to destroy the integrity of the derma. Applications were made under occlusive patches (2" x 2" gauze, covered by adhesive tape). Following application of the test material the entire trunk of each animal was covered with an impermeable occlusive wrapping. The availability of the test site to the animal is restricted by use of everted Elizabethan collars. The wrapping and test material were removed 24 hours following application. The sites were individually examined and scored separately for erythema and edema at 24 and 72 hours. The mean scores for 24 and 72 hour grading were averaged to determine final irritation indices.
Dermal Corrosion: A group of six (6) albino New Zealand rabbits in a weight range of 1.8 - 2.4 kg, were used in this study. The est method was essentially that of Draize et.al. Briefly paraphrased, it consisted of application of 0.5 ml (0.5 g) of the test material to clipped areas of intact skin. Applications were made under occlusive patches (2" x 2 gauze, covered by adhesive tape). Following application of the test material the entire trunk of each animal was covered with an impermeable occlusive wrapping. The animals were then immobilized. The wrapping and test material were removed 4 hours following application. The sites were individually examined and scored separately for erythema and edema at 4 and 48 hours. The mean scores for 4 and 48 hour gradings were averaged to determine final irritation indices. Corrosiveness seen at four and/or 48 hours alone indicates a corrosive material. Tissue destruction (corrosiveness) does not include merely sloughing of the epidermis, or erythema, edema or fissuring.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 72 hours
Score:
0.5
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: for irritation test
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 48 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: for corrosion test
Irritant / corrosive response data:
Irritation test: Only minor scores (1) were seen in the study; these were fully reversible after 24 hours.
Corrosion test: No corrosion effects were noted within the study.
Other effects:
None

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Kronitex TCP has the potential for slight dermal irritation. It is not a dermal corrosive.
Executive summary:

Kronitex TCP was tested for primary dermal irritation and corrosiveness. Results indicate that has a potential for slight dermal irritation. It is not a dermal corrosive. No risk phrase or classification is required.