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
Study period:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted prior to establishment of international guidelines and good laboratory practices. It used a micornized from of the commercial product. Mirconization may impact (e.g. increase) the potential for toxicity.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974

Materials and methods

Principles of method if other than guideline:
Based on U.S. Federal Hazardous Substances Act for determination of "primary" skin irritation.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Preparation of test site:
other: all clipped; 3/6 abraded
Vehicle:
not specified
Controls:
no
Amount / concentration applied:
500 mg/rabbit
Duration of treatment / exposure:
24 hr
Observation period:
up to 72 hr
Number of animals:
3M/3F

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 hr
Score:
0.05
Max. score:
0.2
Reversibility:
no data
Irritant / corrosive response data:
At 24 hr post-dosing, no positive scores were reported for erythema or edema. One of the 6 rabbits had very slight erythema at an abraded site 72 post-dosing. All other sites/rabbits had no redness or swelling at 72 hours.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment