Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted similar to OECD Guideline under GLP conditions. Study report does not specifically identify test guideline followed, however, evaluation of the full study supports that the study is conducted similar to OECD test guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (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):
OD-856 Organomolybdenum mixture


Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:
Approved supplier

- Age at study initiation:
Young adult

- Weight at study initiation:
2.40 +/- 0.14 KG

- Housing:
All housing and care conformed to the standards established in "Guide for the care and Use of Laboratory Animals" DHEW Publications No. (NIH) 85-23.

- Diet (e.g. ad libitum):
Certified rabbit feed ad libitum

- Water (e.g. ad libitum):
Tap water ad libitum

- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
Room temperature

- Photoperiod (hrs dark / hrs light):
12 Hour light dark cycle maintained.

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
4.5, 28, 52 and 76 hours post-exposure
4, 7, 10 and 14 days post exposure
Number of animals:
6
Details on study design:
On the day prior to dosing, the back of each rabbit was clipped free of fur with electric clippers. During this procedure, care was taken to avoide accidental abrasion to the skin. On the day of dosing. a volume of 0.5 ml of the test article was applied to each of 2 test sites. Following application, each test site was occluded with a one-inch square gauze patch held in place with Blenderm(r) tape.

Four hours post-dose, the patches were removed. The exposure sites were gently wiped with clean gauze to remove as much non-absorbed test article as possible. One half hour after unwrapping, the exposure sites were examined and scored separately for both erythema and edema on a graded sc all of 0 to 4 in accordance with the Skin Reaction Code. The exposure sites were again examined and scored at 28, 52 and 76 hours post-dose. Any signs of irritation were noted and observations were made on day 4, 7, 10 and 14 or until all sites returned to normal. Any extraordinary finding. dermal or toxicological, were noted.

In evaluation the average irritation, scores for individual intact exposure sites were recorded separately for each of the scoring time intervals. Based on the 28, 52 and 76 hour observations, a total for erythema and eschar formation was added to a total for edema, then divided by 6 to yield individual animal score. The mean of the six scores was calculated and this score represents the mean primary score.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 76 hours post dosing
Score:
0.73
Max. score:
8
Reversibility:
fully reversible within: 7 days
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
other: 76 hours post dosing
Score:
1
Max. score:
8
Irritation parameter:
overall irritation score
Basis:
animal #2
Time point:
other: 72 hours post dosing
Score:
1.2
Max. score:
8
Irritation parameter:
overall irritation score
Basis:
animal #3
Time point:
other: 72 hours post dosing
Score:
0.83
Max. score:
8
Irritation parameter:
overall irritation score
Basis:
animal #4
Time point:
other: 72 hours post dosing
Score:
0.67
Max. score:
8
Irritation parameter:
overall irritation score
Basis:
animal #5
Time point:
other: 72 hours post dosing
Score:
0.33
Max. score:
8
Irritation parameter:
overall irritation score
Basis:
animal #6
Time point:
other: 72 hours post dosing
Score:
0.33
Max. score:
8
Irritant / corrosive response data:
Slight erythema and eschar formation was the primary effect observed in animals up until 76 hours post dosing. Slight edema formation was observed in two animals post dosing up to 28 hours post dosing.
Other effects:
One animal died on day 8 and another on day 14. Prior to death of the above two animals, anorexia and diarrhea were observed. No lesions or abnormalities were noted in these animals at gross necropsy.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: Modification of J. Soc. Cosmet. Chem. Vol 13, No 6. 1962, p. 281 - 289
Conclusions:
Molyvan 855 is slightly irritating under the conditions of this study.