Registration Dossier

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study was in accordance with OECD guideline and in compliance with GLP.

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
Principles of method if other than guideline:
Nothing to add in this field.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
TCPP

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
no data

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
yes
Amount / concentration applied:
no data
Duration of treatment / exposure:
Exposure period of 4 hours
Observation period:
14 days
Number of animals:
3
Details on study design:
no data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Score:
0
Max. score:
8
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Time point:
other: 1 hour
Score:
2
Max. score:
8
Remarks on result:
other: at the test site of two rabbits
Irritation parameter:
erythema score
Time point:
other: 24 hours
Score:
1
Max. score:
8
Remarks on result:
other: at the test site of two rabbits
Irritation parameter:
erythema score
Basis:
mean
Score:
0.3
Max. score:
8
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: two rabbits that show erythema effects
Irritant / corrosive response data:
no data
Other effects:
No other effect can be found in this study.

Any other information on results incl. tables

Nothing to add in this field.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
It can be concluted taht TCPP does not have a local irritant potential in the rabbit skin.
Executive summary:

Nothing should add in this field.