1,2-Benzenedicarboxylic acid, di-C11-14-branched alkyl esters, C13-rich

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well-documented study report which meets basic scientific principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

not specified

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1,2-Benzenedicarboxylic acid, di-C11-14-branched alkyl esters, C13-rich

EC Number:

271-089-3

EC Name:

1,2-Benzenedicarboxylic acid, di-C11-14-branched alkyl esters, C13-rich

Cas Number:

68515-47-9

Molecular formula:

C34H58O4

IUPAC Name:

1,2-Benzenedicarboxylic acid, di-C11-14-branched alkyl esters, C13-rich diisotridecyl Phthalate

Details on test material:

- Name of test material (as cited in study report): MDR-81-20
- Physical state: clear liquid
- Other: specific gravity 0.954

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dutchland Laboratories, Inc.
- Age at study initiation: young adults
- Weight at study initiation: males (2.8 - 3.4 kg) female (3.2 - 3.9 kg)
- Fasting period before study:
- Housing: individually
- Diet (e.g. ad libitum): Purina rabbit chow ad libitum,
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 45 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22
- Humidity (%): monitored daily
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal and ventral surface and sides from scapular to pelvic area
- % coverage: at least 20%
- Type of wrap if used: occluded; 8-ply gauze wrapped in an impervious plastic sleeve sealed with masking tape

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50, 200, 794, 3160 mg/kg body weight
- Concentration (if solution): used as supplied
- Constant volume or concentration used: no

Duration of exposure:

24 hours.

Doses:

50, 200, 794 and 3160 mg/kg body weight

No. of animals per sex per dose:

2 males and 2 females per dose group

Control animals:

no

Details on study design:

- Duration of observation period following administration: 1, 2, and 4 hours after dosing and daily thereafter for 14 d.
- Frequency of observations and weighing: x2 daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, dermal response

Statistics:

None

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 3 160 mg/kg bw

Mortality:

All animals survived the study; mortality rate 0 %.

Clinical signs:

other: Animals in the 50 and 200 mg/kg dose levels generally exhibited barely perceptible erythema at 24 hours and day 3 post exposure. Most animals in the 794 mg/kg dose level exhibited very slight or well-defined erythema at 24 hours and day 3 post exposure.

Gross pathology:

Postmortem observations at termination of the study revealed findings similar to those seen in control animals killed by carbon dioxide inhalation or were considered unrelated to administration of the test material.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

All animals survived.

Executive summary:

In this study, rabbits were exposed to DTDP at doses of 50, 200, 794 and 3160 mg/kg body weight for 24 hours via occluded dermal contact and evaluated in the methods of Draize. Dermal assessment occurred at 1, 2, and 4 hours and once daily thereafter for 14 days post exposure un-wrapping. Every animal survived the exposure. Dermal responses were generally slight with the intensity and duration of the response occurring in a dose-related pattern. Animals in the 50 and 200 mg/kg dose groups generally exhibited barely perceptible erythema in response to exposure. Most animals in the 794 mg/kg dose group exhibited very slight or well-defined erythema at 24 hours, but were free of any dermal irritation by day 3 post exposure un-wrapping. All animals in the 3160 mg/kg dose group exhibited erythema ranging in severity from very slight to severe at 24 hours and on 3 days post exposure un-wrapping. All signs of dermal irritation were absent by day 14. It is concluded that the LD50 is greater than 3160 mg/kg.