Registration Dossier

Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
chronic toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
analogue approach for alkylethersulfates contained in registered substance - see attached read across justification.

Data source

Reference
Reference Type:
publication
Title:
Environmental and human safety of major surfactants.
Author:
Arthur D. Little, Inc.
Year:
1991
Bibliographic source:
Volume 1. Anionic surfactants. Part 2. Alcohol ethoxy sulfates. Final report to: The Soap and Detergent Association

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 452 (Chronic Toxicity Studies)
GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Reference substance name:
Poly(oxy-1,2-ethanediyl),a-sulfo-w-(dodecyloxy)-, sodium salt
IUPAC Name:
Poly(oxy-1,2-ethanediyl),a-sulfo-w-(dodecyloxy)-, sodium salt
Constituent 2
Reference substance name:
98112-64-2
EC Number:
619-320-2
Cas Number:
98112-64-2
IUPAC Name:
98112-64-2
Test material form:
not specified
Details on test material:
- Poly(oxy-1,2-ethanediyl), a-sulfo-w-(dodecyloxy)-, sodium salt
- Ethoxylation degree: 3EO
- Purity: No data

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female

Administration / exposure

Route of administration:
other: Drinking water study & Feeding study
Vehicle:
unchanged (no vehicle)
Analytical verification of doses or concentrations:
not specified

Examinations

Observations and examinations performed and frequency:
survival, growth, food consumption, body weights, clinical laboratory findings, hamatology and urinalyses.

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Food efficiency:
not examined
Water consumption and compound intake (if drinking water study):
effects observed, treatment-related
Description (incidence and severity):
A slight, but consistently higher water consumption by all rats receiving the test compound in their drinking water and a significant
difference in the empty cecum to body weight ratio of females was oberved.
Ophthalmological findings:
not examined
Haematological findings:
no effects observed
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
no effects observed
Behaviour (functional findings):
not specified
Immunological findings:
not examined
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
not specified
Neuropathological findings:
not examined
Histopathological findings: non-neoplastic:
no effects observed
Histopathological findings: neoplastic:
no effects observed

Effect levels

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Key result
Dose descriptor:
NOAEL
Effect level:
> 250 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: Feeding study
Dose descriptor:
NOAEL
Effect level:
> 75 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: Drinking water study

Target system / organ toxicity

Critical effects observed:
no

Applicant's summary and conclusion

Executive summary:

Poly(oxy-1,2-ethanediyl),a-sulfo-w-(dodecyloxy)-, sodium salt was tested in a chronic toxicity feeding and drinking water study comparable to a OECD 452 guideline study on rats. A NOAEL of 250 mg/kg bw/day (nominal, feeding) was reported.