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: The study was conducted according to the O.E.C.D. test guideline 402 with GLP compliance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
2011

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
As per IUCLID Sections 1.1. 1.2. and 4.1.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
The animals were acquired from Texas Animal Specialties; Humble, Texas the animals were housed in suspended stainless steel cages with wire bottom 1 per cage. The temperature was set to maintaine 22° + 3°C and the relative humidity was set at 3 0-70%. A 12-hour light/dark cycle was maintained and there were 10-12 air changes/hour in the animal room. The animals were allowed PMI Feeds Jnc.TM Formulab #5008; available ad libitum. Sugar Land, Texas municipal water supply analyzed by TCEQ Water Utilities Division; tap water, was available ad libitum (automatic system).

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The test substance was applied evenly to each exposure area in a thin, uniform layer. The area of application was covered with a 2 x 4 in. surgical gauze patch and secured with non-irritating adhesive tape. The trunk of each animal was then wrapped with a veterinary flexible cohesive bandage, secured in place with non-irritating adhesive tape to prevent possible ingestion of the test substance.
Duration of exposure:
24 hr
Doses:
Approximately 2020 mg/kg of body weight.
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Each animal was prepared on the day prior to treatment by clipping the dorsal surface of the trunk free of hair to expose not less than 10% of the total body surface area. Care was taken to avoid abrading the skin. Only those animals with exposure areas free of pre-existing skin irritation or defects were used for this study. All animals were treated with 2020 mg/kg (1.88 mL/kg) of undiluted test substance. An individual dose was calculated for each animal based on its Day 0 body weight just before exposure. After 24 hours, the wrappings were removed. The test sites were gently washed with room temperature tap water and a clean cloth to remove as much residual test substance s possible. Observations for mortality and clinical! behavioral signs of toxicity were made at least three times on the day of dosing (Day 0) and at least once daily thereafter for 14 days. Individual body weights were recorded just prior to dosing and on Days 7 and 14. Observations for evidence of dermal irritation were made at approximately 60 minutes after removal of wrappings, and on Days 4, 7, 11 and 14. On Day 14 after dosing, animals were euthanized by an overdose of CO2. All study animals were subjected to gross necropsy and all abnormalities were recorded.



Statistics:
None required

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
All animals appeared normal for the duration of the study. There were no signs of dermal irritation at any observation during the study.
Body weight:
Animals exhibited normal weekly weight gain during the study.
Gross pathology:
Gross necropsy conducted at termination of the study revealed no observable abnormalities.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The acute dermal LD50 of the test substance for the rat was > 2000 mg/kg of body weight. Therefore the test substance is considered to be nontoxic via the dermal route of exposure. Since no evidence of dermal irritation was observed, the test substance is not a dermal irritant.
Executive summary:

The test substance, 4,4'-Isopropylidenedicyclohexanol, oligomeric reaction products with 1 -chloro-2,3 -epoxypropane, was evaluated for acute dermal toxicity to the rat in an O.E.C.D. 402 test guideline GLP study. The acute dermal LD50 of the test substance for the rat was > 2000 mg/kg of body weight. Therefore the test substance is considered to be nontoxic via the dermal route of exposure. Since no evidence of dermal irritation was observed, the test substance is not a dermal irritant.