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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
2004

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
semi-solid (amorphous): gel
Remarks:
migrated information: paste
Details on test material:
Substance supplied by Rhodia as Miranol JC-HA acute oral toxicity study with no adverse effect at a dose of 2000 mg/kg in female rats (based on 83% purity in water). Results are expressed as nominal dose as 83% material

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
Single dose of 2000 mg/l as 83% pure material
No. of animals per sex per dose:
6 Females
Dosage volume 20 ml/kg
Control animals:
no
Details on study design:
Clinical observations for 14 days post-treatment, followed by gross necropsy.
No tissue samples were retained
Body weights checked on Day 1, 8 and 15
Statistics:
Not necessary

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
discriminating dose
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths were reported
Clinical signs:
Other than post-dose hypoactivity and piloerection in all animals in all animals typical of distress of dosing procedures, no adverse effects noted
Body weight:
Slight reduction in body-weight gain in 4/6 animals compared to historical data
Gross pathology:
No adverse effects

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No adverse effect level > 2000 mg/kg
The substance is considered to be non-hazardous according to classification criteria.
Executive summary:

Substance supplied by Rhodia as Miranol JC-HA acute oral toxicity study with no adverse effect at a dose of 2000 mg/kg in female rats (based on 83% purity in water). The data was derived by a good quality GLP limit test in 2004

 

The lower molecular weight would suggest that has the potential to be more biologically active than the coco-amine derivative and together with the weight of evidence from similar substances, is considered to be a valid substance for read-across for acute toxicity