1-Propene, hydroformylation products, high-boiling

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

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:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Male and female Wistar rats were administered orally (by gavage) to 5000 mg/kg bw and 2000 mg/kg bw test substance to determine the oral toxicity.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Name of test material (as cited in study report): Oxooel 740 roh
- Substance type: product mixture
- Physical state: yellowish brown liquid
- Composition of test material, percentage of components: 2,2,4-trimethyIpentanediol-1,3-mono-i-butyrat / 2-ethylhexandiol-1,3 / 2,2-dimethylhexandiol-1,3-mono-i-butyrate: 33%, 2,2-dimethylhexanediol-1,3-di-i-butyrate / 2-ethyIhexanediol-1,3-mono-n-butyrate: 22%, 1-ethylpentenyl (2)-4-propyl-5,5 dimethyl-dioxane-1,3 / C8-diol-mono-i-butyrate: 14%, i-di-n-butylacetale / 2-ethylhexanol: 13%, 2,2-dimethylhexanediol-1,3: 8%, n-butanol: 3%, 2-ethylhexyl-n-butyrate: 1.5%, 2,4-di-propyl-5,5-dimethyl-dioxane-1,3: 1.5%, trimer-n-butyraldehyd: 1.0%, n-butyl-n-butyrate: 0.6%, 2,2,4-trimethylpentanediol-1,3: 0.3%, 2-ethyl-4-methylpentanediol-1,3-n-i-butyrate: 0.3%, 4-methyl-2-ethylpentanol: 0.2%, n-di-n-butylacetal: 0.2%, 2-ethylhexyl-i-butyrate: 0.2%, 4-methyl-2-ethylpentenal / 2-ethylhexanal: 0.1%, i-di-i-butylacetal: 0.1%, 2-i-propyl-4-propyl-5,5-dimethyl-dioxane-1,3: 0.02%, trimer-i-butyraldehyd: 0.01%, phosphor: 0.0013%, unknown substances: 3%, water: 0.1%

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GmbH
- Weight at study initiation: - mean(males): 181 g (5000 mg/kg), 182 g (2000 mg/kg); - mean(females): 169 g (5000 mg/kg), 182 g (2000 mg/kg)
- Fasting period before study: 16 h
- Housing: 5 animals/cage
- Diet: ad libitum (KLIBA)
- Water: tap water ad libitum
- Acclimation period: at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: olive oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 5000 mg/kg bw: 50% (w/v), 2000 mg/kg bw: 40% (w/v)
- Justification for choice of vehicle: substance is sensitive to hydrolysis


MAXIMUM DOSE VOLUME APPLIED: 5000 mg/kg bw: 10 mL/kg, 2000 mg/kg bw: 5 mL/kg

Doses:

2000 mg/kg bw, 5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days;
- Frequency of observations and weighing: recording of signs and symptoms: several times on the day of administration, at least once each workday; check for moribund and dead animals: twice each workday and once on holidays;
- Necropsy of survivors performed: yes;
- Other examinations performed: body weights;

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

- 2000 mg/kg: males: 0/5, females: 0/5; - 5000 mg/kg: males: 1/5, females: 0/5

Clinical signs:

- males: dyspnea (30 min - 1 day), apathy (30 min - 1 day), abnormal position (1 h - 4 h), staggering (30 min - 1 day), atonia (1 h - 4 h), paresis (30 min - 4 h), pain reflex absent (1 h - 4 h), corneal reflex absent (1 h - 4 h), narcotic-like state (1 h - 4 h), spastic gait (1 day), piloerection (1 day - 3 days), exsiccosis (1 day), poor general state (30 min - 1 day);
- females: dyspnea (30 min - 4 h), apathy (30 min - 4 h), staggering (30 min - 4 h), paresis (1 h - 4 h), piloerection (1 day), poor general state (30 min - 4 h)

Body weight:

- 5000 mg/kg: males: 197 g (day 3), 228 g (day 7), 264 g (day 13); females: 207 g (day 3), 219 g (day 7), 232 g (day 13); - 2000 mg/kg: males: 232 g (day 5), 241 g (day 7), 269 g (day 13); females: 216 g (day 5), 222 g (day 7). 227 g (day 13);

Gross pathology:

Male animal that died: general congestive hyperemia; sacrificed animals (males and females): no abnormalities detected

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

Oxooel 740 is practically non-toxic after oral administration.

Executive summary:

Groups of 5 Wistar rats per sex and dose were administered 5000 mg/kg bw and 2000 mg/kg bw of the test substance, respectively. Only 1 male animal in the 5000 mg/kg bw group died. Clinical signs could be detected until day 3 after administration. The pathological observations showed a general congestive hyperemia in the dead male animal and no abnormalities in the sacrificed animals

Conclusion:

Oxooel 740 is practically non-toxic after oral administration.