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Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
November from 06th to 20th, 1979
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: unsuitable for the assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Principles of method if other than guideline:
10 female rats were dosed with 5000 mg/kg body weight, once, by gavage. After the observation period of 14 days, the surviving animals were killed by O2 gas, dissected and examined macroscopically.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Fluorescent Brightener 371
IUPAC Name:
Fluorescent Brightener 371

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 172 - 186 g (mean 182 g).
- Fasting period before study: the animals were deprived of food for 16 hours before and 2 hours after treatment.
- Housing: the animals were kept in groups in plastic cages on wood shavings.
- Diet: Altromin 1324 (Altromin GmbH), ad libitum.
- Water: ad libitum.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
A 25 % emulsion in water (25 g / ad 100 ml) was prepared.
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
Ten rats
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the animals were weighed weekly.
- Necropsy of survivors performed: yes; the surviving animals were killed by O2 gas at the end of the follow-up period, dissected and examined macroscopically.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
No animal died at the dose given.
Clinical signs:
other: About 60 minutes after the treatment, all animals showed squat position and hair retention. Forty minutes later, passivity, miosis, dilated eyelids, and increased lacrimation were observed. 24 hours post application, all animals were free from clinical sy
Gross pathology:
The section of animals killed after the end of the experiment was macroscopically without any special features.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
LD50 (females) > 5000 mg/kg bw
Executive summary:

The substance was assessed for oral acute toxicity potential, using female rats. For the treatment, a 25 % emulsion in water (25 g/100 ml) was prepared and administered in the dosage of 5000 mg/kg body weight, once by gavage. After the observation period of 14 days, the surviving animals were killed by O2 gas, dissected and examined macroscopically.

No deaths occurred; about 60 minutes after the treatment, all animals showed squat position and hair retention. Forty minutes later, passivity, miosis, dilated eyelids, and increased lacrimation were observed. 24 hours post application, all animals were free from clinical symptoms. Body weight and body weight gain were normal. The section of animals killed after the end of the experiment was macroscopically without any special features.

Conclusion

LD50 (females) > 5000 mg/kg bw