Blue MOP 6314

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 28 March 2000 to 13 April 2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

other: Body responsible for the test

Title:

Unnamed

Year:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Doses:

2000 mg/kg b.w

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

Male: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0

Clinical signs:

Signs of toxicity related to dose levels:
Aucune mortalité au cours de l'étude.


Piloérection, prostration et diarhée à J1 et J2, coloration
de la peau des animaux, ainsi que des selles noires et une
coloration pourpre des urines.

Pas de modification du poids.

Gross pathology:

Effects on organs:
Aucune anomalie à l'examen macroscopique des animaux.

Applicant's summary and conclusion

Interpretation of results:

other: not classified

Remarks:

according to the CLP classification (1272/2008)

Conclusions:

The oral LD50 value of test item in Wistar rats was established to exceed 2000 mg/kg body weight.

Executive summary:

Assessment of acute oral toxicity in the rat (Acute Toxic Class Method).

The study was carried out based on the guidelines described in: EC Commission Directive

96/54/EC, Part B.1 tris "Acute Toxicity-Oral, Acute Toxic Class Method" and OECD No.423,

"Acute Oral Toxicity - Acute Toxic Class Method".

The substance was administered by oral gavage to three Wistar rats of each sex at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (day 15).

No mortality occurred.

Piloerection, hunched posture and/or diarrhoea was noted among females on day 1, and lethargy and/or diarrhoea was noted among males on day 1 or 2.

Black discolouration and/or staining of various body parts, black faeces and/or purple urine was noted in all animals during the study period.

The body weight gain shown by the animals over the study period was considered to normal.

No abnormalities were found at macroscopic postmortem examination of the animals. The oral LD50 value of test item in Wistar rats was established to exceed 2000 mg/kg body weight.

Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC), BLUE MOP 6314 does not have to be classified and has no obligatory labelling requirement for oral toxicity.