Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981-10-22 to 1981-11-04
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Procedures st forth in the Federal Insecticide, Funigcide, and Rodenticide Act (FIRFA)
Version / remarks:
Federal Insecticide, Fungicide, and Rodecticide Act, Part 163, Title 40; Code of the Federal Regulations 40 CRF 163.81.
GLP compliance:
yes
Remarks:
Good Laboratory Practices Regulations, Part 58, Title 21. Code of the Federal Regulations 40 CRF 163.81*2.
Test type:
other: Limit test
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate
EC Number:
222-020-0
EC Name:
Tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate
Cas Number:
3319-31-1
Molecular formula:
C33H54O6
IUPAC Name:
tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate
Details on test material:
Tris(2-ethoxyhexyl)trimellitate (CAS 3319-31-1): 98.95 %
2-Ethylhexanol: 0.5 %
Miescellaneous Esters: 1.00 %

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
Young adult male and female New Zealand albino white rabbits were supplied by Becker, Centralia, Kansas. Upon receipt of the animals, each was identified by means of a numbered ear tag. All animals were housed in temperature and humidity controlled rooms. Prior to treatment, all animals were acclimated to laboratory conditions for a minimum of 7 days.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Five male and five female rabbits weighing 2.3 to 3.2 kg were used to determine the acute dermal toxicity of test-compound.. Twenty-four hours prior to treatment the hair on the back of each rabbit was clipped so as to expose approximately 10% of the body surface area. Before dosing, epidermal abrasions were made longitudinally over the exposure area. The abrasions were sufficiently deep to penetrate the stratum corneum but not so deep as to cause bleeding. A dosage of 2.0 ml/kg was applied to the exposure area of three male and three female rabbits. The other two male and two female rabbits served as control animals. A 2- x 2-in. gauze pad was placed on the exposure area to prevent seepage of the compound from the area. Each rabbit was then wrapped with a rubber dam. After 24 hours of exposure, the rubber dam and gauze pad were removed, and the exposure area was wiped to remove any remaining test material. The rabbits were observed for a total of 14 days; no toxic signs were noted. A gross necropsy was performed on all animals at the end of the 14-day observation period; no gross pathology was observed. The acute dermal LD50 was> 2.0 ml/kg. Results are summarized in Table 1. Individual animal body weights are listed in Table 2.
Duration of exposure:
24 hours
Doses:
2.0 mL/kg
No. of animals per sex per dose:
3 male and 3 female rabbits with test dose
2 male and 2 female rabbits for control
Control animals:
yes, concurrent no treatment
Details on study design:
The rabbits were observed for a total of 14 days; no toxic signs were noted. A gross necropsy was performed on all animals at the end of the 14-day observation period. Body weight was measured on day 1, 7 and 14 of observation period.
Statistics:
not specified (single dosage used)

Results and discussion

Preliminary study:
no data
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 mL/kg bw
Based on:
test mat.
Remarks on result:
other: No confidence limits calculable as no mortality
Mortality:
none
Clinical signs:
other: No toxic signs were noted. A gross necropsy was performed on all animals at the end of the 14-day observation period; no gross pathology was observed.
Gross pathology:
A gross necropsy was performed on all animals at the end of the 14-day observation period; no gross pathology was observed.

Any other information on results incl. tables

Table 1 Acute Dermal Toxicity of the sample

 Dose (mL/kg)  No. of Animals (all abraded)

 Mortality

No. Dead / No. Dosed

 0  2 M, 2 F  0 / 4
 2.0  3 M, 3 F  0 / 6

Table 2 Individual Animal Body weights

 Animal No.  Sex  Dose (ml/kg)  Body Weights (kg)      
       Day 1  Day 7  Day 14
 RB50  Male  0.0  3.2  3.4  3.6
 RB35  Male  0.0  3.2  3.4  3.6
 RB56  Female  0.0  2.7  3.0  3.1
 RB26  Female  0.0  2.9  3.1  3.3
                
 RB93  Male  2.0  2.3  2.3  2.5
 RB77  Male  2.0  2.4  2.4 2.5
 RB75  Male  2.0  2.3  2.2  2.4
 RB78  Female  2.0  2.3  2.5  2.7
 RB84  Female  2.0  2.4  2.6  2.7
 RB80  Female  2.0  2.4  2.5  2.6

Applicant's summary and conclusion

Interpretation of results:
other: EU GHS (CLP) criteria not met
Conclusions:
Under the conditions of this test the sample has an acute dermal LD50 in rabbits of >2.0 ml/kg.
Executive summary:

The acute dermal toxicity test was conducted as a limit test according to Federal Insecticide, Fungicide, and Rodecticide Act, Part 163, Title 40; Code of the Federal Regulations 40 CRF 163.81 and in compliance with GLP criteria.

A dosage of 2.0 mL/kg of the test item (unchanged) was applied to the exposure area (approximately 10% of the body surface area) of 3 male and female rabbits. The other two male and two female rabbits served as control animals. A 2x2-inch gauze pad was placed on the exposure area to prevent seepage of the compound from the area. Each rabbit was then wrapped with a rubber dam. After 24 hour of exposure, the rubber dam and gauze pad was removed and the exposure area was wiped to remove any remaining test material. The rabbits were observed for a total of 14 days; no toxic signs were noted.

The results indicate that the test item has an acute dermal LD50 in rabbits of > 2.0 ml/kg.