Octanoic acid, mixed tetraesters with 2-ethylhexanoic acid, heptanoic acid and pentaerythritol

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Cross-reference

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

acute toxicity: oral

Type of 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:

guideline study

Remarks:

read-across

Justification for type of information:

Refer to the section 13 of IUCLID dataset for details on the read across justification. The acute oral toxicity study with the read across substance is considered sufficient to fulfil the information requirements as further explained in the provided endpoint summary.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Species:

rat

Strain:

Crj: CD(SD)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories Japan, Atsugi breeding center
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 191-214 g
- Fasting period before study: yes
- Housing: 1-3 animals/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 9-16 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23.5-24.2°C
- Humidity (%): 48-81%
- Air changes (per h): 8/h
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 6.40%w/v
- Amount of vehicle (if gavage): 0.5 mL/100 g weight
- Justification for choice of vehicle: Stability and uniformity of concentration

Doses:

300 and 2000 mg/kg bw

No. of animals per sex per dose:

6 animals per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 d
- Frequency of observations and weighing: everyday for observation and Days 0, 7, 14 for weighting
- Necropsy of survivors performed: yes

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No motarity

Clinical signs:

other: One animal at 300 mg/kg bw suffered from diarrhea after 1 h of dosing. But it recovered after 4 h of dosing. There were no abnormality in other animals.

Gross pathology:

There were not any abnormalities for gross pathology at necropsy.

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral median dose (LD50) of the substance in the female Crj:CD(SD) IGS rats was determined to be >2000 mg/kg bw.

Executive summary:

A study was conducted to determine the acute oral toxicity of the read-across substance CAS 7299 -99 -2 in Crj:CD(SD) IGS rats according to OECD Guideline 423. Groups of rats were orally administered the test substance at dose levels of 300 and 2000 mg/kg bw as a solution in corn oil. Clinical signs and bodyweight development were monitored during the study period of 14 d. All animals were subjected to gross necropsy. No mortality was observed in either test group. No clinical signs were observed and there were no treatment-related effects on the body weight. No abnormalities were observed at necropsy. Under the study conditions, the acute oral LD50 of the substance in Crj:CD(SD)IGS rats was determined to be >2000 mg/kg bw (MHLW, 2005).