Alkenes, C6-11 (branched), hydroformylation products, distn. residues, heavy cracked fraction

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

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, C6-11 (branched), hydroformylation products, distn. residues, heavy cracked fraction

EC Number:

701-314-7

Molecular formula:

CnH2n+2O2. n=24-33

IUPAC Name:

Alkenes, C6-11 (branched), hydroformylation products, distn. residues, heavy cracked fraction

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 the registered substance is greater than 5000 mg/kg.

Executive summary:

The acute oral toxicity of the registered substance 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 the registered substance is greater than 5000 mg/kg.