Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
06/09/1987 - 06/23/1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP run study following Guideline EPA OPP 81-2.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 81-2 (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:
clear, colorless liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
Young adult (~14 weeks of age) New Zealand White rabbits were procured from Hazleton Research Products, Inc, maintained individually in screen-bottom cages suspended over absorbant pan liners for urine and feces collection, in temperature and humidity controlled quarters (19 - 23 degrees C and 36-66 % RH), provided access to water ad libitum, and a measured amount of Purina High fiber Rabbit Chow. The annimals were held for an acclimation period of at least 7 days. Animal husbandry and housing at HLA complied with standards outlined in the "Guide for the Care and Use of Laboratory Animals." Test animals were uniquely identified by animal number and corresponding ear tag.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Approximately 24 hours before test material application, each rabbit's back was shaved with an electric clipper. The shaved area made up approximately 20% of the total body surface. The test material was applied to each animal's back at a dosage level of 2.0 g/kg. The area of application was covered with a 10 x 10 cm gauze patch secured with paper tape and overwrapped with Saran Wrap and Elastoplast tape. Twenty-four hours later the bandages were removed and the backs were washed with lukewarm tap water and wiped with disposable paper towels. Collars were applied to restrain the test animals during the twenty-four hour exposure period.
Duration of exposure:
24 hours
Doses:
2.0 g/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Following exposure, the animals were observed for clinical signs and mortality at 1, 2.5 and 4 hours after test material administration. Thirty minutes after removal of the test material the initial dermal irritation reading was made. Subsequent readings of dermal irritation were made on study days 3, 7, 10, and 14. The animals were observed daily for clinical signs and twice daily (morning and afternoon) for mortality. The animals were weighed just prior to test material application, at 7 days, and at study termination.
Statistics:
Other than averaging body weights, no other statistical method was performed.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 000 mg/kg bw
Mortality:
No mortality was seen throughout the duration of the study.
Clinical signs:
Only one animal showed a clinical effect of holding its head to the left from day 7 through day 14 of observations.
Body weight:
Average Body Weights (g)
Initial Day 7 Terminal
Male 2329 2485 2525
Female 2452 2686 2707
Gross pathology:
No visible lesions were found when the animals were examined postmortem.
Other findings:
Dermal irritation consisted of slight to moderate erythema, edma, and desquamation, and slight atonia, coriaceousness and fissuring.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
The test material Isodecyl Benzoate was evaluated for its dermal toxicity potential in male and female rabbits. The estimated dermal LD50 is greater than 2.0 g/kg of body weight.
Executive summary:
Isodecyl Benzoate was evaluated for dermal toxicity potential in 5 male and 5 female young adult New Zealand White rabbits according to the EPA OPP 81-2 Acute Dermal Toxicity protocol. Approximately 24 hours before test material application, each rabbit's back was shaved with an electric clipper. The shaved area  made up approximately 20% of the total body surface. The test material was applied to each animal's back at a dosage level of 2.0 g/kg. The area of application was covered with a 10 x 10 cm gauze patch secured with paper tape and overwrapped with Saran Wrap and Elastoplast tape. Twenty-four hours later the bandages were removed and the backs were washed with lukewarm tap water and wiped with disposable paper towels. Collars were applied to restrain the test animals during the twenty-four hour exposure period. Following exposure, the animals were observed for clinical signs and mortality at 1, 2.5 and 4 hours after test material administration. Thirty minutes after removal of the test material the initial dermal irritation reading was made. Subsequent readings of dermal irritation were made on study days 3, 7, 10, and 14. The animals were observed daily for clinical signs and twice daily (morning and afternoon) for mortality. The animals were weighed just prior to test material application, at 7 days, and at study termination. Clinically, dermal irritation consisted of slight to moderate erythema, edma, and desquamation, and slight atonia, coriaceousness, and fissuring. No mortality was seen throughout the duration of the study. Only one animal showed a clinical effect of holding its head to the left from day 7 through day 14 of observations. Average Body Weights were for males 2329, 2485, and 2525 grams (, Day 7, and Day 14, respectively) and for females were 2452, 2686, and 2707 grams (Day of dose administration, Day 7, and Day 14, respectively). Gross pathology revealed no visible lesions when the animals were terminated.  The estimated dermal LD50 for Isodecyl Benzoate in male and female rabbits is greater than 2.0 g/kg of body weight.