Benzene, poly(propene) derivatives

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Name of test material (as cited in study report): AL305B
- Physical state: clear, colourless, slightly viscous liquid
- Lot/batch No.: TS07003
Physical description: clear, colourless liquid
Expiry date: 01 March 2008
Storage: room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Portage, MI
- Age at study initiation:
- Weight at study initiation:
- Fasting period before study:
- Housing: individually in suspended stainless steel cages
- Diet (e.g. ad libitum): PMI Certified Rodent Chow #5002 ad libitum
- Water (e.g. ad libitum): municipal tap water ad libitum
- Acclimation period: minimum of five days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 °C
- Humidity (%): 46-64%
- Air changes (per hr): 10-15 per hour
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

The test item was administered as a 200 mg/mL solution diluted in corn oil.

Doses:

2000 mg/kg (dose volume 10 mL/kg)

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

Clinical abnormalities observed for a minimum of two times on day 0 and daily thereafter. Body weights were obtained at days -1, 0 (prior to dosing), 7 and 14.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

None

Clinical signs:

None

Body weight:

One single female lost weight in second week. All other animals gained body weight.

Gross pathology:

No gross internal findings

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

Oral LD50 (rat:female) > 2000 mg/kg bw under the conditions of this test.

Executive summary:

The single-dose oral toxicity of AL3O5B was evaluated in Sprague DawIey rats. A limit test was performed in which three female rats received a single oral administration of the test material at a dose level of 2000 mg/kg body weight. Since no clinical signs were noted; three additional female rats received a single oral administration of the test article at a dose level of 2000 mg/kg. Following dosing, all rats were observed daily and weighed weekly. A gross necroscopy examination was performed on all test animals at the time of scheduled euthanasia (day 14).

No mortality and no clinical signs were noted during the study. One female had a slight loss in body weight during the second week. All other animals gained body weight during the test period. No gross internal findings were observed at necropsy on study day 14.

Under the conditions of this test, the acute oral LD50 of AL305B was estimated to be greater than 2000 mg/kg in the female rat.