Reaction mass of 2,2'-(vinylenedi-p-phenylene)bis[5-methylbenzoxazole] and 2,2'-(vinylenedi-p- phenylene)bisbenzoxazole and 2-[4-[2-[4-(benzoxazol-2- yl)phenyl]vinyl]phenyl]-5-methylbenzoxazole

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February from 02 to 15, 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted 24th February 1987

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fluorescent Brightener 219

IUPAC Name:

Fluorescent Brightener 219

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF-Zucht.
- Age at study initiation: 7 weeks males and 6 weeks females.
- Weight at study initiation: males mean 180 g (173 - 189 g); females mean 167 g (161 - 170 g).
- Fasting period before study: the feed was suspended 16 hours before the treatment and was resumed 3-4 hours after the treatment.
- Housing: fully-air-conditioned rooms, in Makrolon cages (type 4) on limewood granules; groups of 5 animals.
- Diet: standard diet Altromin 1324, ad libitum.
- Water. tap water, ad libitum.
- Acclimation period: at least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 50 ± 20 %
- Photoperiod: 12 hours daily.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: strength mash (potato starch in deionized water)

Details on oral exposure:

VEHICLE
- Preparation: test item was suspended in a 2 % strength mash (potato starch in deionized water) using a mortar and pestle and homogeneously distributed using a magnetic stirrer.
- Concentration: 20 % (w/w)
- Application volume: 10 ml/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weight of the animals was determined weekly.
- Necropsy of survivors performed: yes; at the end of the observation period, the test animals were killed by carbon dioxide, dissected and examined for macroscopically visible changes.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No death occurred.

Clinical signs:

No symptoms occurred during the entire observation period.

Body weight:

No impairment of body weight development was recorded.

Gross pathology:

The animals at the end of the post-observation period were free of macroscopically visible changes.

Applicant's summary and conclusion

Interpretation of results:

other: not classified, according to the CLP Regulation ((EC 1272/2008)

Conclusions:

LD50 (male and female) > 2000 mg/kg bw

Executive summary:

The acute oral toxicity potential of test item was investigated according to the procedures outlined into the OECD guideline 401 and according to the EU Method B.1. 5 males and 5 females rats were treated at a dosage level of 2000 mg/kg bw. The test item was suspended in a 2 % strength mash (potato starch in deionized water) using a mortar and pestle and homogeneously distributed using a magnetic stirrer; the substance was administered as a single dose by gavage. After administration of the compound, the animals were observed for 14 days; at the end of the observation period, surviving animals were killed and an autopsy performed.

No death occurred and no symptoms were observed during the entire observation period. No impairment of body weight development was recorded. The animals at the end of the post-observation period were free of macroscopically visible changes.

Conclusion

LD50 (male and female) > 2000 mg/kg bw