Registration Dossier
Registration Dossier
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EC number: 268-952-1 | CAS number: 68155-26-0
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- Read across approach adequate to support 7.6.1 according to "Guidance on information requirements and chemical safety assessment Chapter R.6: QSARs and grouping of chemicals" (ECHA 2008) and Read-Across Assessment
Framework (RAAF) (ECHA 2017)
Cross-reference
- Reason / purpose for cross-reference:
- other: WOE
Reference
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- Read across approach adequate to support 7.6.1 according to "Guidance on information requirements and chemical safety assessment Chapter R.6: QSARs and grouping of chemicals" (ECHA 2008) and Read-Across Assessment
Framework (RAAF) (ECHA 2017) - Reason / purpose for cross-reference:
- other: WOE
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- not specified
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Duration of treatment / exposure:
- 13 weeks
- Dose / conc.:
- 0 mg/kg diet
- Dose / conc.:
- 25 mg/kg diet
- Dose / conc.:
- 80 mg/kg diet
- Dose / conc.:
- 250 mg/kg diet
- No. of animals per sex per dose:
- groups of 20 female, 20 males
- Control animals:
- yes
- Body weight and weight changes:
- no effects observed
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- A transient increase in blood glucose concentration at 6 weeks was observed when the male animals were consuming 250 mglkg per day Lauramide DEA
- Details on results:
- no other effects observed in comparisoin with control .
- Dose descriptor:
- NOAEL
- Effect level:
- 250 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no effects
- Critical effects observed:
- not specified
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Reference substance 002
- Cas Number:
- 120-40-1
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: SPF
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Duration of treatment / exposure:
- 13 weeks
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg diet
- Dose / conc.:
- 0.1 mg/kg diet
- Dose / conc.:
- 0.5 mg/kg diet
- Dose / conc.:
- 1 mg/kg diet
- Dose / conc.:
- 2 mg/kg diet
- No. of animals per sex per dose:
- 15 female, 15 males
- Control animals:
- yes
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence):
- Two male rats in the 1 .O% dietary group developed bronchopneumonia and were killed on Days 23 and 58, respectively. No other deaths occurred in any group during the test period
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Growth was normal in the 0.1% group, slightly reduced in the 0.5% group, and moderately reduced in those animals consuming 1.0 or 2.0% Lauramide DEA.
- Description (incidence and severity):
- Growth retardation was associated with reduced food intake, at and above the 0.5% level
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Hematological values were normal except for lower hemoglobin, hematocrit, and red blood cell count values in the rats fed 1 .O and 2.0% Lauramide DEA. Serum glutamic oxaloacetate transaminase activities were increased in animals fed diets of 0.5, 1 .O, and 2.0% Lauramide DEA
- Details on results:
- no other effects observed
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 50 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- food consumption and compound intake
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
