Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the O.E.C.D. test guideline with GLP compliance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
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, TX and weighted on the dosing Day: Male: 244-264 gm; Female: 176-185 gm The animals were housed in suspended stainless steel with wire bottom cages 1 per cage. The animal room was maintained at actual Tempt/Relative Humidity of 20-22°C /34-91% with 12-hour light/dark cycle and 10-12 air changes/hour. PMI Feeds Inc.TM Formulab #5008 was available ad libitum and
Municipal water supply (Sugar Land, TX) analyzed by TCEQ Water Utilities Division; tap water, was also available ad libitum (automatic system)






Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The animals were 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. 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 2000 mg/kg of body weight.
No. of animals per sex per dose:
Five
Control animals:
no
Details on study design:
After 24 hour exposure period, the dermal 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 as 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 derinal irritation were made at approximately 60 minutes after removal of the dermal 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:
None
Body weight:
The animals gained weight normally.
Gross pathology:
There were no observable abnormalities.
Other findings:
There was no evidence of dermal irritation following the 24 hr exposure.

Applicant's summary and conclusion

Interpretation of results:
relatively harmless
Remarks:
Migrated information and not irritating. Criteria used for interpretation of results: OECD GHS
Conclusions:
The test substance has a an acute dermal LD50 of > 2000 mg/kg of body weight in the rat. Furthermore, the test substance was not irritating to the skin under the conditions of the study.
Executive summary:

The test substance, 1,2,3,6 -Tetrahydrophthalic anhydride, oligomeric reaction products with 2,2 -dimethylpropane-1,3 -diol, was evaluated in an O.E.C.D. 402 rat acute dermal toxicity study. The acute dermal LD50 was > 2000 mg/kg of body weight. Furthermore, the test substance was not irritating to the skin under the conditions of the study with a 24 hr exposure period. .