Sulfuric acid, mono-C12-14 (even numbered)-alkyl esters, compds. with ethanolamine

Acute Toxicity: oral

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:

other: see 'Remark'

Remarks:

GLP Guideline study According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Justification for type of information:

Refer to the Category Approach Justification document in point 13.

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

Test material information

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

Control animals:

no

Results and discussion

Effect levels

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:

other: 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

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:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU