Ester reaction products of 1,4-Benzenedicarboxylic acid with C11-14 iso-alcohols, C13-rich

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14 days

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Acceptable, well-documented study report equivalent or similar to OECD guideline 401

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OTS 798.1100 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

416-740-6

EC Name:

-

Molecular formula:

Can vary from C30H53O4 (di-C11 rxn product) to C36H65O4 (di-C14 rxn product)

IUPAC Name:

Ester reaction products of 1,4-Benzenedicarboxylic acid with C11-14 iso-alcohols, C13-rich

Details on test material:

Test article is a colorless homogeneous liquid. This material as stated in the Product Physical And
Chemical Data sheet is a terephthalate ester (di-tridecyl terephthalate).

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

Five male and five female young adult New Zealand White rabbits were used in this study. The body weights at dosing ranged from 2.8-3.2 Kg for the males and from 2.7-3.2 Kg for the females. The terminal weights ranged from 3.1-3.4 Kg for the males and 2.9-3.4 Kg for the females. The animals were identified by individual ear tags and cage cards. The temperature of the study room was maintained at 69-72° F with a relative humidity of 37-66%.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

The back of each animal was shaved the day before administration of the test substance. The dose was applied evenly with a 10 cc syringe to the back of each animal followed by a layer of 8-ply gauze to cover the test site. The gauze was covered by a rubber dam and the anterior and posterior edges of the dam securely taped. A plastic Elizabethan collar was placed on each animal to prevent oral ingestion of the test substance and mechanical irritation of the test site. Following an approximately 24 hour exposure period, the collars, dam, and gauze were removed and the residual test substance wiped from the site.

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

All animals survived treatment.

Clinical signs:

other: The following clinical observations that may have been caused by treatment were noted in one or more animals: soft stool, decreased fecal output, decreased food consumption, and nasal discharge.

Gross pathology:

No gross pathological changes were noted at necropsy.

Any other information on results incl. tables

No abnormal clinical observations or gross pathology were noted on the animals that lost weight.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 for 1,4-Benzenedicarboxylic Acid, Di-C11 -14 -Isoalkyl Ester, C13-Rich following acute dermal application was greater than 2000 mg/kg for male and female New Zealand white rabbits. These findings do not warrant classification of MRD-94-953 as an acute oral toxicant under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.

Executive summary:

1,4-Benzenedicarboxylic Acid, Di-C11 -14 -Isoalkyl Ester, C13 -Rich was administered via occlusive dermal application for 24 hours to New Zealand white rabbits (5 males and 5 females/dose) at 2000 mg/kg to assess the acute dermal toxicity. Animals were observed daily for 14 days post dosing. No overt signs of toxicity were apparent. No mortality was observed. All animals which survived to study termination were free of abnormalities at postmortem examination. A single female rabbit lost 0.1 kg body weight between days 7 and 14. The LD50 for 1,4-Benzenedicarboxylic Acid, Di-C11 -14 -Isoalkyl Ester, C13-Rich greater than 2000 mg/kg. These findings do not warrant classification of 1,4-Benzenedicarboxylic Acid, Di-C11 -14 -Isoalkyl Ester, C13-Rich as an acute dermal toxicant under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.