Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

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:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
6 animals, 3 animals/group

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
A single oral gavage administration was followed by a 14-day observation period.
Doses:
2000 mg/kg bw was selected to be the starting dose
No. of animals per sex per dose:
6 animals, 3 animals/group
Control animals:
not specified

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality observed
Mortality:
ACIDE HYDROXY did not cause mortality at a dose level of 2000 mg/kg bw.
Clinical signs:
All animals were symptom-free during the observation period at a dose level of 2000 mg/kg bw.
Body weight:
There were no treatment related body weight changes. Body weights were within the range commonly recorded for this strain and age.
Gross pathology:
There was no evidence of the macroscopic changes at a dose level of 2000 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
Under the conditions of this study, the acute oral LD50 value of the test item ACIDE HYDROXY was found to be above 2000 mg/kg bw in female Crl:WI Wistar rats.
According the GHS criteria, classification of ACIDE HYDROXY can be ranked as "Category 5 or Unclassified" for acute oral exposure.
Executive summary:

The single-dose oral toxicity study with ACIDE HYDROXY was performed according to the acute toxic class method (OECD 423 and Commission Regulation (EC) No 440/2008 of 30 May 2008, B.1.tris) in Crl:WI Wistar female rats.

Two groups of three female Crl:WI rats were treated with the test itemat a dose level of 2000 mg/kg body weight (bw) (Group 1 and Group 2).

ACIDE HYDROXY did not cause mortality at a dose level of 2000 mg/kg bw.

Under the conditions of this study, the acute oral LD50 value of the test item ACIDE HYDROXY was found to be above 2000 mg/kg bw in female Crl:WI Wistar rats.

According the GHS criteria, classification of ACIDE HYDROXY can be ranked as "Category 5 or Unclassified" for acute oral exposure.