Registration Dossier

Diss Factsheets

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

Constituent 1
Reference substance name:
Alkenes, C6-11 (branched), hydroformylation products, distn. residues, heavy cracked fraction
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.