1,2-Benzenedicarboxylic acid, isononyl ester, manuf. of, by-products from

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Acceptable, well-documented study report equivalent or similar to OECD guideline (420): GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Alkenes, C7-9, hydroformylation products, distn. residues, heavy cracked fraction

EC Number:

308-482-7

EC Name:

Alkenes, C7-9, hydroformylation products, distn. residues, heavy cracked fraction

Cas Number:

98072-31-2

IUPAC Name:

98072-31-2

Details on test material:

- Name of test material (as cited in study report): MRD-85-608
- Physical state: yellow liquid
- Analytical purity: assumed 100%

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Breeding Laboratories, Stone Ridge, NY
- Age at study initiation: approximately 10 weeks
- Weight at study initiation: males (295-321 g), females (209-215 g)
- Fasting period before study: 12 hours
- Housing: 5 per cage
- Diet (e.g. ad libitum): Purina certified rodent chow, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 22 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-21
- Humidity (%): 40-70
- Air changes (per hr): n.a
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 5000 mg/kg

Doses:

5000 mg/kg (5.75 ml/kg based on a density of 0.87 g/ml)

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 1, 2, 4, and 6 hours after dosing and daily thereafter for 14 days.
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology

Statistics:

Means and standard deviations of the body weights.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Remarks on result:

other: No deaths observed

Mortality:

No deaths observed

Clinical signs:

other: Minimal adverse clinical events were observed. Unthrifty coat and ano-genital staining being the most frequently noted. Soft stool, oral discharge, thin hair coat and scab on tail were also noted at a low incidence. No observable abnormalities were see

Gross pathology:

7 of the 10 test animals had no effects. Lungs mottled red were observed in three animals.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral LD50 for CAS# 98072-31-2 is greater than 5000 mg/kg.

Executive summary:

The acute oral toxicity of CAS# 98072-31-2 was evaluated when administered to 5 male and 5 female rats by oral gavage at the limit dose of 5000 mg/kg.  Observations were made as to the nature, onset, severity, and duration of toxicological signs 1, 2, 4, and 6 hours after dosing and daily thereafter for 14 days.  Minimal adverse clinical signs were observed.  All animals survived to study termination.  The acute oral LD50 for CAS# 98072-31-2 is greater than 5000 mg/kg.