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Registration Dossier
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EC number: 939-597-6 | CAS number: 68610-66-2
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Justification for type of information:
- Refer to the Category Approach Justification document provided in IUCLID6 Section 13.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- Urinalysis and neurobehaviour were not examined.
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Alcohols, C12-14, ethoxylated, sulfates, sodium salts
- EC Number:
- 500-234-8
- EC Name:
- Alcohols, C12-14, ethoxylated, sulfates, sodium salts
- Cas Number:
- 68891-38-3
- Molecular formula:
- not applicable, UVCB
- IUPAC Name:
- Alcohols, C12-14(even numbered), ethoxylated < 2.5 EO, sulfates, sodium salts
Constituent 1
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
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 25, 75, 225 mg/kg bw
Basis:
nominal in water
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- According to Guideline.
- Positive control:
- Not necessary
Examinations
- Observations and examinations performed and frequency:
- According to Guideline.
- Sacrifice and pathology:
- According to Guideline.
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):
- no effects observed
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- > 225 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No treatment-related effects observed.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- For the systemic toxicity after repeated oral application a NOAEL of greater than 225 mg/kg bw/day can be deduced.
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