Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Repeated dose toxicity: oral

Currently viewing:

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:
1986

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

Constituent 1
Reference substance name:
Reference substance 002
Cas Number:
120-40-1

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