PIGMENT RED 5021B

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1991-07-02 until 1991-07-16

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD guideline, GLP compliance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Details on test material:

- Purity: > 90%
- Physical properties: solid, red
- Storage conditions: room temperature

Test animals

Species:

rat

Strain:

other: Tif: RAI f

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CIBA-GEIGY Limited, Animal Production, 4332 Stein / Switzerland
- Age at study initiation: 6 to 8 weeks
- Weight at study initiation: 177 to 202 g
- Housing: the animals were housed in Macrolon cages type 4, with standardized soft wood bedding
- Diet: rat diet (NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland), ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 + 2 °C
- Humidity: 55 + 10 %
- Air changes: approximately 15 air changes per hour
- Photoperiod: a 12 hour/day light cycle

IN-LIFE DATES: 1991-06-28 to 1991-07-16

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80

Details on oral exposure:

VEHICLE:
- Amount of vehicle (if gavage): 10 ml/kg bw

Doses:

Single dose of 2000 mg/kg bw

No. of animals per sex per dose:

5 rats

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality: daily; a.m. and p.m. on working days, a.m. on weekend days
Signs and symptoms: daily for 14 days
Body weight: immediately before administration and on days 7 and 14
- Necropsy of survivors performed: yes, the animals were submitted to a gross necropsy at the end of the observation period.

Statistics:

From the body weights, the group means and their standard deviations were calculated.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured

Clinical signs:

other: Piloerection, hunched posture and dyspnea were seen, being common symptoms in acute tests. The animals recovered within 5 days.

Gross pathology:

At autopsy, no deviations from normal morphology were found.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU