Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Deviations:
yes
Remarks:
lack on details of test substance within the study report. Missing details were however received by the sponsor.
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
no

Test material

Constituent 1
Reference substance name:
Sulfuric acid, mono-C12-14-alkyl esters, sodium salts
EC Number:
287-809-4
EC Name:
Sulfuric acid, mono-C12-14-alkyl esters, sodium salts
Cas Number:
85586-07-8
Molecular formula:
C12-14H25-29SO4Na
IUPAC Name:
Sulfuric acid, C12-14-alkyl (even numbered) esters, sodium salts

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
According to guideline.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
500 and 2000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females per dose
Control animals:
no

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 500 - < 2 000 mg/kg bw
Based on:
test mat.
Mortality:
All male and one female animal treated at 2000 mg/kg bw died in the course of the first day of the study.
Clinical signs:
At 2000 mg/kg bw: All animals showed hunched back, decrease in motor activity, ataxia and pallor. In addition the males also presented piloerection, and the females hypotonia.
At 500 mg/kg bw: No clinical signs
Body weight:
At 2000 mg/kg bw: Slight loss of of bodyweight in the course of the first day
At 500 mg/kg bw: No effects
Gross pathology:
One male of the 2000 mg/kg bw dose group showed hemoperitoneum, gastric and small intestine mucous membranes very congested, and the inside of this organs with bloody looking liquid.
One female of the 2000 mg/kg bw dose group showed dilation of the whole of the small and cecum intestines, without apparent lesions.

Applicant's summary and conclusion

Interpretation of results:
other: Acute tox. oral 4, H302. Classification according to Regulation (EC) No 1272/2008 (CLP/EU GHS)