Bis(2-ethylhexyl) terephthalate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

24-hour exposure followed by 14 day observation period

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study conducted prior to introduction of Good Laboratory Practices; data from a summary report; limited number of animals. Study was conducted by an internal Eastman Kodak Company method, developed prior to established guidelines. The results of this study are valid for classification insofar as the conditions of exposure are at least as stringent as modern guidelines.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

no guideline followed

Deviations:

not specified

Principles of method if other than guideline:

Method is an in vivo study using three guinea pigs. Following depilation of the abdomen of each animal, a single dose of the test substance is applied under an occlusive wrap for 24 hours. Animals are observed following removal of the cuff, and on Days 7 and 14. In addition to observations for mortality, dermal reactions and weight changes were also recorded.

GLP compliance:

no

Remarks:

Study conducted prior to GLPs

Test type:

other: internal Eastman Kodak method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Bis(2-ethylhexyl) terephthalate

EC Number:

229-176-9

EC Name:

Bis(2-ethylhexyl) terephthalate

Cas Number:

6422-86-2

Molecular formula:

C24H38O4

IUPAC Name:

1,4-bis(2-ethylhexyl) benzene-1,4-dicarboxylate

Constituent 2

Reference substance name:

Reference substance 001

Cas Number:

6422-86-2

Details on test material:

-Test substance (as cited in report): Bis (2-ethylhexyl) terephthalate

Test animals

Species:

guinea pig

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

Test animals:
-Weight at study initiation: 535 - 575 g

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Following depilation of each animal's abdomen, a single dose of 5.0, 10.0, or 20.0 mL/kg bw of the test substance was applied under an occlusive cuff and wrap. This is equivalent to 4920, 9840 or 19,680 mg/kg bw based on the density (0.984 g/cm3) of the undiluted test material. After a 24-hour exposure period, the cuffs and wrappings were removed.

Duration of exposure:

24 hours

Doses:

5.0, 10.0, and 20.0 mL/kg bw

No. of animals per sex per dose:

1 animal/dose (sex not specified)

Control animals:

no

Details on study design:

Three guinea pigs (sex, age, and initial weights not provided) were used. Following depilation of the guinea pig abdomens, a single dose of 5.0, 10.0, or 20.0 mL/kg bw of the test substance was applied under an occlusive wrap prepared from a pad of gauze held in place with an impervious cuff made of rubber dental dam material. The cuff was wrapped securely around the torso of the guinea pig and held in place with non-irritating tape. Animals were exposed for 24 hours, then the cuffs were removed. Animals were observed following removal of the cuff, and on Days 7 and 14. In addition to observations for mortality, dermal reactions were also noted. Guinea pigs were weighed prior to administration of the test substance and at termination of the 14-day observation period.

Statistics:

not performed

Results and discussion

Effect levels

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 20 mL/kg bw

Mortality:

None

Clinical signs:

other: No signs of test material absorption or systemic toxicity were noted during the study. Signs of irritation at the application site were limited to moderate to gross edema (24 hours) and slight desquamation (7 and 14 days).

Gross pathology:

not performed

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

Three guinea pigs were exposed to the test substance at dose levels of 5, 10, or 20 mL/kg bw for 24 hours under an occlusive cuff. The dermal LD50 in guinea pigs was > 20.0 mL/kg bw (equivalent to 19,680 mg/kg bw).

Based on an acute dermal LD50 value of greater than 20 mL/kg bw in guinea pigs, di (2-ethylhexyl) terephthalate is not classified as a toxicant for classification and labeling for acute lethality by the dermal route according to GHS.

Executive summary:

In an acute dermal toxicity study, 3 guinea pigs were exposed for 24 hours under occlusive contact to 5, 10 or 20 mL/kg bw of di (2-ethylhexyl) terephthalate. Under the conditions of this study, no deaths occurred and the dermal LD50 was considered to be > 20.0 mL/kg bw. No signs of skin absorption or systemic toxicity were evident during the study. At the application sites, signs of irritation caused by the solvent included moderate to gross edema at 24 hours, and slight desquamation at both 1 and 2 weeks after test substance administration. A body weight gain was noted in all animals over the 2-week observation period. Based on the results of this study, di (2-ethylhexyl) terephthalate presents a low toxicity hazard but may cause significant irritation.