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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
Study period:
2005
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study performed according to OECD guideline 420 and in compliance to GLP.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005
Reference Type:
other: Published secondary source
Title:
Unnamed
Year:
2006
Report Date:
2006

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test item : 2,2'-[[4-[(2-hydroxyethyl)amino]-3-nitrophenyl]imino]bisethanol
EC number : 251-410-3
Batch number : 31394
Content : 99.5%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5% suspension of carboxymethylcellulose in purified water
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
1(sighting), 4(main experiment)
Control animals:
no

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
95% CL:
ca. 0
Remarks on result:
other: confidence level cannot be established therefore expressed as circa 0
Mortality:
No mortality was recorded.
Clinical signs:
Hypoactivity, piloerection and dyspnea were observed in all females within 4 hours of treatment. Blue spots were noted on the tail and/or on the fur of all females from day 1 up to day 8.
Body weight:
The overall body weight gain of the animals was not affected by treatment with the test item.
Gross pathology:
At necropsy, no apparent abnormalities were observed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the experimental conditions, the maximal non-lethal dose of the test item was 2000 mg/kg by oral route in rats. In accordance with Directive 67/548 and Regulation (EC) No 1272/2008 the substance is not classified.
Executive summary:

The acute oral toxicity of the substance was assessed according to OECD guideline 420 (acute oral toxicity - fixed dose method) in compliance to GLP. Under the experimental conditions, the maximal non-lethal dose of the test item was 2000 mg/kg by oral route in rats. In accordance with Directive 67/548 and Regulation (EC) No 1272/2008 the substance is not classified.