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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
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.

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
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