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Toxicological information

Acute Toxicity: oral

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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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
Fluorescent Brightener 363
IUPAC Name:
Fluorescent Brightener 363

Test animals

Species:
rat
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Rats: Tif: RAIf (SPF) strain.
- Weight at study initiation: ranged from 160 to 180 grams.
- Fasting period before study: the rats were starved during one night before starting the treatment.
- Housing: animals were housed in groups of 5 in Macroloncages (type 3).
- Diet: rat food - NAFAG, Gossau SG -, ad libitum.
- Water: ad libitum.
- Acclimation period: the animals were adapted to our laboratories for a minimum of 4 days.

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1° C
- Relative humidity: 55 ± 5 %
- Photoperiod: 14 hours light cycle day.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Details on oral exposure:
Test item was suspended with polyethylene glycol (PEG 400). Before treatment the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.
Doses:
4640, 6000 and 7750 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: physical condition and rate of deaths were monitored throughout the whole observation period.
- Necropsy of survivors performed: yes; surviving animals were submitted for necropsy whenever they died, survivors at the end of the observation period.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 7 700 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed at 4640 and 6000 mg/kg bw, while 3 females out of 5 died at the dose of 7750 mg/kg bw.
Clinical signs:
other: Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, curved position and ruffled fur. The surviving animals recovered within 8 to 12 days.
Gross pathology:
No substance related gross organ changes were seen.

Any other information on results incl. tables

Dose mg/kg Concentration % of formulation No animals Died within
1 hr 24 hrs 48 hrs 7 days 14 days
M F M F M F M F M F M F
4640 30 5 5 0 0 0 0 0 0 0 0 0 0
6000 30 5 5 0 0 0 0 0 0 0 0 0 0
7750 30 5 5 0 0 0 3 0 3 0 3 0 3

Applicant's summary and conclusion

Interpretation of results:
other: not classified, according to the CLP Regulation (EC) No 1272/2008
Conclusions:
LD50 (rat M/F): 7700 mg/kg
Executive summary:

Acute oral toxicity of the test substance was evaluated in a study conducted according to a methodology equivalent to OECD Guideline 401. Three groups each consisting of 5 males and 5 females were administered the test substance through oral route at the doses of 4640, 6000 and 7750 mg/kg bw. Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, curved position and ruffled fur. The surviving animals had recovered within 8 to 12 days. No mortality was observed at 4640 and 6000 mg/kg bw, while 3 females out of 5 died at the dose of 7750 mg/kg bw. Surviving animals were killed and autopsied after an observation period of 14 days. No substance related gross organ changes were seen. Hence, based on the findings of the study, it can be concluded that the acute oral LD50 in rats of both sexes observed over a period of 14 days is approximately 7700 mg/kg bw.

Conclusion

LD50 (rat M/F): 7700 mg/kg