Registration Dossier

Administrative data

Endpoint:
skin irritation / corrosion, other
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
OECD Guideline 430 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test Method (TER))
Qualifier:
according to
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
Sponsor's identification
Description
Batch number
Date received
Storage conditions
PCMX
cream coloured, crystalline solid
285/13847
27 September 2001
room temperature, in the dark
Specific details on test material used for the study:
The test. material was a white crystalline-like powder and was stored at room temperature throughout the study in a square, clear glass jar with a black plastic lid .

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Animals will be acclimated to the laboratory for at least one day before being used. Animals will be housed singly in suspension cages with wire mesh floors and will be fed PURINA LABORATORY RABBIT CHCM (or other comparable diet) and water ad libitum. The animals will be maintained on a 12-hour light/12-hour dark cycle.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
physiological saline
Controls:
not specified
Amount / concentration applied:
0.5g of test material with 0.3ml of physiological saline.
Duration of treatment / exposure:
Up to 72 hours.
Observation period:
72 hours
Number of animals:
6
Details on study design:
This standardized procedure was conducted according to the general conditions of the protocol and specifically as designated on the Project Instruction Sheet and Supplemental Instructions, as applicable. As such , it satisfies the criteria established by the Federal Insecticide , Fungicide, and Rodenticide Act ( 40 CFR ) , the Toxic Substances Control Act ( 40 CFR ) , and the OECD Guidelines.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Primary Skin Irritation in Rabbits Following a 4-Hour Dermal Application
Score for each Rabbit
Skin Observation Total Average Condition Time No.I No.2 No.3 No.4 No.S NO .b Score Score

Erythema Formation

Site A

-B c

-D A -B

Intact 1/2 - 1 hr 1 1 1 1 1 1 6 1.00
24 hr OH OH OH 0 OH OH 0 0.00
48 hr OH OH OH 0 OH OH 0 0.00
72 hr OH OH OH 0 OH OH 0 0.00
Edema Formation
Site A -B -c D
- A- -B
Intact 1/2 - 1 hr 0 0 0 0 0 0 0 0.00
24 hr 0 0 0 0 0 0 0 0.00
48 hr 0 0 0 0 0 0 0 0.00
72 hr 0 0 0 0 0 0 0 0.00
Primary Irritation Index (PII) 0.3


Any other information on results incl. tables

Primary Skin Irritation in Rabbits Following a 4-Hour Dermal Application

Score for each Rabbit

Skin       Observation                                          Total Average Condition              Time       No.I       No.2       No.3       No.4       No.S       NO .b       Score       Score

Erythema Formation

Site       A

-B       c

-D       A       -B

Intact       1/2 - 1 hr       1       1       1       1       1       1       6       1.00

      24 hr       OH       OH       OH       0       OH       OH       0       0.00

      48 hr       OH       OH       OH       0       OH       OH       0       0.00

      72 hr       OH       OH       OH       0       OH       OH       0       0.00

Edema  Formation

      Site       A       -B       -c       D

-       A-       -B              

Intact       1/2 - 1 hr       0       0       0       0       0       0       0       0.00

      24 hr       0       0       0       0       0       0       0       0.00

      48 hr       0       0       0       0       0       0       0       0.00

      72 hr       0       0       0       0       0       0       0       0.00

Primary Irritation Index (PII)       0.3

Applicant's summary and conclusion

Interpretation of results:
other: The test material is classified in Toxicity Category IV by dermal administration.
Conclusions:
The primary skin irritancy of was evaluated in compliance with the conditions specified in the regulation for the enforcement of the Federal Insecticide, Fungicide, and Rodenticide Act ( 40 CFR ) , the Toxic Substances Control Act ( 40 CFR ) , and the OECD Guidelines.

No irritation persisted 72 hours following application.

The Primary Irritation Index ( PII ) was found to be 0 .3 based on erythema and edema.
No changes in the coloration or texture of the skin were noted . No evidence of corrosion ( necrosis ) was found .
Executive summary:

As above