Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: according to guideline and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Lot/Batch: 08097

The substance was tested by the test house using a trade name that is considered confidential business information. The name assigned to the substance has therefore been changed to Cargill BP-A.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Animals Used in the Study:
Number and Species: 3 New Zealand White rabbits (Oryctolagus cuniculus)
Sex: 1 male and 2 females (females were nonpregnant and nulliparous)
Weight/Age Range: 2.16 2.36 kilograms / at least 10 weeks old (adult) weighed to the nearest 10 g
Health Status: healthy, not previously used in other experimental procedures
Animal Purchase: Millbrook Breeding Labs, Amherst, MA
Animal Identification: ear marker
Acclimation: minimum 5 days, under same conditions as for the actual test
Animal Selection: selected from larger pool and examined to ensure lack of adverse clinical signs

Animal Care and Maintenance:
Animal Room Temperature: 68 ± 5 °F
Animal Room Relative Humidity: 30 70%
Air Exchanges per Hour: a minimum of 10 changes per hour
Lights: 12hour light/dark cycle, full spectrum fluorescent lights
Housing: individually housed
Cages: suspended stainless steel
Bedding: hardwood chips, P.W.I. Industries, StHyacinthe, Quebec, Canada (noncontact)
Animal Rations: TEK Hi-Fiber Rabbit Diet 2031, Harlan Teklad, Madison, WI, ad libitum
Water: tap water, ad libitum
There will be no known contaminants present in the feed, water, or bedding expected to interfere with the test data.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.4 mL
Duration of treatment / exposure:
Initial test: observation at 3 minutes, 1 hour, 4 hours
Confirmatory test: 4 hours
Observation period:
Erythema and edema scores are determined at 60 minutes, 24, 48, and 72 hours after patch removal. Further observations may be needed to establish reversibility.
Number of animals:
3 Animals

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 60 minutes/24 hours/48 hours/72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 60 minutes/24 hours/48 hours/72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritant / corrosive response data:
No irritation/corrosion

Any other information on results incl. tables

Body Weights: All of the animals exhibited weight gain during the study.

Clinical Observations: No overt signs of toxicity were evident in any of the animals during the course of the study.

Dermal Irritation: No signs of erythema or edema were observed in any of the three animals during the study.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance was evaluated for its potential to produce skin irritation and/or corrosion after a single topical application for four hours to the intact skin of New Zealand White rabbits. No signs of erythema or edema were noted at any observation period. Based upon the evaluation criteria of the protocol, the test substance is considered a non-irritant.