4-poly(propyl), benzene sulfonic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

14 August 2007 to 20 September 2007

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

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

Sponsor's identification: AS305BD
Description: dark brown, viscous liquid
Lot number: TS07002
Analytical purity: 100%
Storage conditions: room temperature in the dark

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 and Kingston, NY
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 158-183 g prior to dosing
- Housing: suspended stainless steel cages
- Diet (e.g. ad libitum): PMI Certified Rodent Chow #5002 ad libitum (except during fasting)
- Water: municipal tap water ad libitum
- Acclimation period: minimum of five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-21 degrees C
- Humidity (%): 40-77 %
- Air changes (per hr): 10-15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hr light/12 hr dark

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

The test article was administered as 30 mg/mL and 200 mg/mL mixtures w/v in corn oil and dispensed on the day of dosing. The mixtures were stirred continuously during dosing.

Doses:

Single oral administration of the test article at the dose levels of 300 and 2000 mg/kg. Individual doses were calculated on basis of animal's fasted body weight.

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical observations - twice on day 0 and daily thereafter; bodyweights - prior to fasting (day -1), prior to dosing (day 0), days 7 and 14.
- Necropsy of survivors performed: yes (body cavities were opened and examined; no tissues were retained).

Statistics:

Based on the results of each dose level, the LD50 was estimated as follows:

- <50% mortality - LD50 was estimated as greater than the administered dose
- =50% mortality - LD50 was estimated as equal to the administered dose
- >50% mortality - LD50 was estimated as less than the administered dose

Results and discussion

Preliminary study:

Not applicable

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

None

Clinical signs:

The following clinical observations were noted at the 300 mg/kg dose - decreased activity, few feces, diarrhea, urine staining, sailvation and congested breathing.

The following clinical observations were noted at the 2000 mg/kg dose - decreased activity, few feces, soft stools, mucoid stools, no feces, fecal staining, urine staining, dark material around facial area, breathing abnormalities, unkempt appearance, rough coat, and cool to touch

Body weight:

All animals gained body weight during the test period.

Gross pathology:

No gross internal findings were observed at necropsy on study day 14

Other findings:

None.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

Under the conditions of this test, the acute oral LDso of AS305BD was estimated to be greater than 2000 mg/kg in the female rat.

Executive summary:

In line with OCED Guideline 423, the oral toxicity of AS305BD was evaluated in rats. A limit test was performed in which three female rats received a single oral administration of 300 mg/kg bodyweight. As no mortality was recorded, three further animals received the same dose. A second limit test was subsequently performed in which three female rats received a single oral administration of 2000 mg/kg bodyweight. As no mortality was recorded, three further animals received the same dose.

No mortality occurred during the study although clinical observations were made in animals at both doses. All animals gained bodyweight during the study. No gross internal findings were observed at necroscopy.

Under the conditions of the test, the acute oral LD50 of AS305BD was estimated to be > 2000 mg/kg in the female rat.