Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted similar to OECD Guideline under GLP conditions.

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Although the common name is slightly different (OD-856 versus OD-855), the test substance is the same. The distinction between the two common names is dependent upon the production/process method used.

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
10 young adult NZ white rabbits were obtained from Ace Animals, Inc for use in this study. All housing and care conformed to the standards established in the "Guide for the Care and Use of Laboratory Animals" DHEW Publication No. (NIH) 85-23. All animals were acclimated for a minimum of at lead 5 days. During this acclimation period, the rabbits were examined with respect to their general health to assure their suitability as test animals.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 hours
Doses:
2.0 g/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
On the day prior to dosing, the back of each rabbit was clipped free of fur with electric clippers. The test article was administered to intact skin under an occlusive binder at a level of 2.0 g/kg bw. The binder consisted of a layer of plastic wrap and stockinette sleeve all securely held in place with masking tape. Animals were evaluated at the end of the 15-day post application observation period.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 other: g/kg bw
Based on:
test mat.
Mortality:
No deaths occurred
Clinical signs:
Observation Males Females
Soft stools 3/5 0/5
Nasal discharge 1/5 0/5
Anorexia 1/5 0/5
Body weight:
Mean Body weight data (kg)
Initial Day 8 Day 15
Males 2.20 2.27 2.43
+ or-0.23 (5) +or-0.16(5) +or-0.22(5)

Females 2.32 2.40 2.48
+or-0.14(5) +or-0.20(5) +or -0.36(5)

Values are means +or- standard deviations for the number of observations in ( ).
Gross pathology:
No noteworthy findings.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this study, the acute lethal dermal dose (LD50) of Molyvan 855 was estimated to be greater than 2.0 g/kg of body weight in New Zealand White Rabbits.