Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 28 June 1988 to 3 August 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): XRD-498

- Physical state: white powder
- Analytical purity: 99.6%

- Lot/batch No.: AGR-240043

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hazleton Dutchland, Inc., Denver PA

- Weight at study initiation: 2.7 to 3.1 kg
- Housing: individually
- Diet (e.g. ad libitum): Purina Certified Rabbit Chow #5322, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period:2 weeks

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped free of fur
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):A 0.5 g aliquot of test material applied under a 2.5 cm2 gauze patch


Duration of treatment / exposure:
4 hours
Observation period:
30 minutes, 24 hours, 48 hours, 72 hours
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: back of rabbits
- % coverage: 2.5 cm2
- Type of wrap if used: A 0.5 aliquot of test material was applied to the back under a 2.5 cm2 gauze patch and held in place with non-irritating tape. The gauze patch was covered with a flannel bandage taped to the rabbit. The rabbits were returned to individual cages following application of the test material.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with a damp disposable towel to remove any residual test substance.
- Time after start of exposure: 4 hours


SCORING SYSTEM: 0 to 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: all 6 animals
Time point:
other: 30 min, 24 h, 48 h, 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal:
Time point:
other: 30 min, 24h, 48h, 72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
see table in "remarks on results"
scores of 0 indicate no erythema or no edema

Any other information on results incl. tables

Individual Rabbit Skin Irritation Grades
Observation time following patch removal Animal Number Erythema Edema
within 30 minutes 88A2920 0 0
88A2921 0 0
88A2922 0 0
88A2923 0 0
88A2924 0 0
88A2925 0 0
24 hours 88A2920 0 0
88A2921 0 0
88A2922 0 0
88A2923 0 0
88A2924 0 0
88A2925 0 0
48 hours 88A2920 0 0
88A2921 0 0
88A2922 0 0
88A2923 0 0
88A2924 0 0
88A2925 0 0
72 hours 88A2920 0 0
88A2921 0 0
88A2922 0 0
88A2923 0 0
88A2924 0 0
88A2925 0 0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: US EPA pesticides
Conclusions:
There were no signs of dermal irritation in any of the rabbits at any time post-treatment.
Executive summary:

Aliquots of 0.5 g of XRD-498 were applied for four hours to the intact skin on the back of six New Zealand White rabbits. No signs of dermal irritation were observed at any time post-treatment. XRD-498 was not irritating to the skin of rabbits.