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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:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EPA OTS 798.4470 (Acute Dermal Irritation)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Lot # TPPX-Z18-04080A (Borg-Warner)

Test animals

Species:
guinea pig
Strain:
not specified

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: 10% w/v in Mineral Spirits
Controls:
no
Amount / concentration applied:
The test substance was in a suspension (10 % w/v) in Mineral Spirits.
Duration of treatment / exposure:
24 hr application to skin, followed by 24 hr rest. Repeated for 10 applications.
Observation period:
24 and 48 hrs after challenge, which followed 2 week rest period after cycle of 10 applications (20 days)
Number of animals:
10 male
Details on study design:
Exposure to skin for 24 hrs, followed by 24 hr rest period, repeated for 10 applications. A two-week rest period followed the tenth skin application after which the skin was challenged and observed for 24 and 48 hours.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24 h
Score:
1
Max. score:
1
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
48 h
Score:
0.4
Max. score:
1
Reversibility:
other: erthyma disappeared in more than half of the animals within 24 hrs, no information about longer follow-up period
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48 h
Score:
0
Max. score:
0
Remarks on result:
other: No signs of edema in any of the animals.
Irritant / corrosive response data:
Full individual animal data are provided in the attached table.

Applicant's summary and conclusion

Interpretation of results:
Category 3 (mild irritant) based on GHS criteria
Conclusions:
The results of this study show only slight irritation (mean PDII of 1 at 24 hrs and a mean PDII of 0.4 at 48 hrs) after 10 repeated 24 hr applications to the skin and a subsequent challenge after a 2 week rest period.
Executive summary:

The results indicate that TPP is slightly irritating to the skin and not a skin sensitizer.