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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:
27 April 2006 - 22 May 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study has been performed according to OECD and/or EC guidelines and according to GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Reference substance name:
No. 338 Red
IUPAC Name:
No. 338 Red
Details on test material:
Description: red powder
Batch number: 50670

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Doses:
300 and 2000 mg/kg bw
No. of animals per sex per dose:
3 females were given 300 mg/kg bw, 6 females were given 2000 mg/kg bw
Control animals:
no

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
Female: 300 mg/kg bw; Number of animals: 3; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 6; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
Il n'y a eu aucun signe de toxicité systémique quel que soit
le groupe.
Gross pathology:
Effects on organs:
Tous les animaux ont montré des gains de poids corporel
prévus au cours de la période d'étude.


Aucune anomalie n'a été notée lors de l'autopsie quel que
soit le niveau de dosage.

Any other information on results incl. tables

No mortality was observed during the study period.

There were no signs of systemic or local toxicity.

Red-coloured staining of the faeces was noted in all animals during the study.

All animals showed expected gains in body weight over the study period.

No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 of the test material in the female rat was > 2000 mg/kg bw. The substance needs no classification for acute oral toxicity.

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