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Toxicological information

Acute Toxicity: oral

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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study conducted according to internationally accepted testing guidelines. The test was performed on a similar substance within the category of Stilbene Fluorescent Whitening Agents, the analogous dihydroxyethyl derivative disulphonated sodium salt. Justification for Read Across is reported in the endpoint summary and in the Category Justification Report attached to the Section 13 of this dossier.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
limited data
GLP compliance:
not specified
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Stain: Albino rat, strain not specified.
- Age at study initiation: young

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
3 x sex x dose
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, histopathology

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality observed
Clinical signs:
Dyspnoea, exophthalmoses, ruffled fur, and curved body position were seen, being common symptoms in acute toxicity testing. The animals recovered within 11 days
Gross pathology:
At autopsy, no deviations from normal morphology were found.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information according to the CLP regulation Criteria used for interpretation of results: EU
Conclusions:
LD50 > 5000 mg/kg bw.
Executive summary:

Method

The exploratory (approximate) acute oral LD50 for test substance was investigated by administering a single dose of 5000 mg/kg bw by gavage to the young adult albino rats.

Results

LD50 > 5000 mg/kg bw.