Carmine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

The study will be available 30/08/2019

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Carmine

EC Number:

215-724-4

EC Name:

Carmine

Cas Number:

1390-65-4

Molecular formula:

C22H20O13

IUPAC Name:

Carmine

Test material form:

solid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

Species and strain Rat, Hsd: Sprague Dawley SD
Sex: Females (nulliparous and non-pregnant)
Age: 6 to 7 weeks old
Weight range at arrival: 155 to 160 grams
Acclimatisation period: At least 5 days
Veterinary health check: During acclimatisation period

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

Dosing method: The formulated test item was administered, by gavage, at a dose volume of 20 mL/kg using a plastic feeding tube attached to a graded syringe.

Doses:

2000mg/kg

No. of animals per sex per dose:

An initial sighting study was performed on a single female animal which was dosed at 2000mg/kg. No mortality occurred and the animal was observed for a period of 14 days. A main study was then performed on a group of 4 females, dosed at 2000mg/kg and observed for a period of 14 days.

Control animals:

no

Details on study design:

Frequency of treatment: Once only, on the day of dosing.
Fasting procedure: Food was removed fromthe cages overnight prior to dosing (Day -1) and was made available approximately 4 hours after dosing.
Dose calculation: On the day of dosing (Day 1), the amount of the formulated test item to be administered was calculated for each fasted animal according to body weight.
Dosing method: The formulated test item was administered, by gavage, at a dose volume of 20 mL/kg using a plastic feeding tube attached to a graded syringe

Results and discussion

Preliminary study:

An initial sighting study was performed on a single female animal which was dosed at 2000mg/kg. No mortality occurred and the animal was observed for a period of 14 days.

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Mortality and morbidity: Throughout the study all animals were checked twice daily.

Clinical signs:

other: Clinical signs Animals were observed for clinical signs as indicated below: – Day of dosing – · Session 1: on dosing – · Session 2: approximately 0.5 hour after dosing – · Session 3: approximately 2 hours after dosing – · Session 4: approximately 4 hours

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Classification: No category
Signal word: No signal word required
Hazard statement: No hazard statement required