Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Details not available
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Data has been provided by ECHA from a previous notification. The data has been reviewed by a suitable Competent Authority and adjudged to be suitable for registration.

Data source

Reference
Reference Type:
other: Provided by ECHA
Title:
Unnamed
Year:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzyltributylammonium 4-hydroxynaphthalene-1-sulfonate
EC Number:
402-240-5
EC Name:
Benzyltributylammonium 4-hydroxynaphthalene-1-sulfonate
Cas Number:
102561-46-6
Molecular formula:
C29H41NO4S
IUPAC Name:
benzyltributylazanium 4-hydroxynaphthalene-1-sulfonate
Test material form:
not specified
Details on test material:
Not specified

Test animals

Species:
rat
Strain:
other: Crl : COBS CD (SD) BR
Sex:
male/female
Details on test animals or test system and environmental conditions:
Details not available

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: 1% Aqueous methylcellulose
Details on oral exposure:
Details not available
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 males & 5 females
Control animals:
not specified
Details on study design:
Details not available
Statistics:
Not specified

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
not specified
Mortality:
Male: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0Female: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:There were no deaths. Signs of reaction to treatment observed in all rats within three hours of dosing were piloerection, increased salivation, abnormal body carriage (hunched posture), abnormal gait (waddling) and diarrhoea. Complete recovery was reached 2 days after treatment.
Body weight:
Slightly low bodyweight gains were recorded on Day 8 for two male rats.
Gross pathology:
Terminal autopsy findings were normal. Effects on organs: None seen.
Other findings:
Not specified

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
LD50 >5000 mg/kg bw
Executive summary:

The acute toxicity: oral was measured using the OECD 401 and EU B1 test methods. Details are not available, but the data has been reviewed by a suitable EU Competent Authority and provided by ECHA. LD50 >5000 mg/kg bw.