Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
8 February 2010 to 22 March 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study with a minor protocol deviation and compliant with GLP. The study integrity was not affected by the deviations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
deviations from the minimum level of relative humidity occurred
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
deviations from the minimum level of relative humidity occurred
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
deviations from the minimum level of relative humidity occurred
Qualifier:
according to
Guideline:
other: JMAFF, 12 Nousan, Notification No 8147, November 2000, including the most recent partial revisions
Deviations:
yes
Remarks:
deviations from the minimum level of relative humidity occurred
GLP compliance:
yes
Test type:
acute toxic class method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Substance 3, NLP 500-090-6

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
propylene glycol
Doses:
2000 mg/kg
No. of animals per sex per dose:
3 animals per dose group
Control animals:
no
Details on study design:
single dosage on Day 1.Observations until day 15.
Statistics:
No statistical analysis was performed (The method used is not intended to allow the calculation of a precise LD50 value).

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
discriminating dose
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: According the OECD guideline 423 the LD50 cut-off value is considered to larger than 5000 mg/kg bw
Mortality:
no mortality occurred
Clinical signs:
piloerection was noted in three animals on Day 1. In addition one animal showed hunched posture on Day 1 and 2.
Body weight:
The body weight gain shown by the animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain.
Gross pathology:
No abnormalities were found at macroscopic post mortem examination of the animals.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
The oral LD50 value of Modified Small Vinyl Ester in Wistar rats was established to exceed 2000 mg/kg bw.According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg bw.
Executive summary:

Modified Small Vinyl Ester was tested for acute oral toxicity using the acute toxic class method (OECD guideline 423) with a minor protocol deviation and compliant with GLP. The study integrity was not affected by the deviations.

The oral LD50 value of Modified Small Vinyl Ester in Wistar rats was established to exceed 2000 mg/kg bw.

According to the OECD test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg bw.