PIGMENT RED 5021B

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 test, GLP compliance

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal 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: 7 to 8 weeks
- Weight at study initiation: 212 to 249 g
- Housing: individually housed in Macrolon cages type 3, with standardized soft wood bedding
- Diet: rat diet (NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland), ab libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 + 2 °C
- Humidity: 5 5 + 10 %
- Air changes: approximately 15 air changes per hour
- Photoperiod: a 12 hour/day light cycle

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

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

Details on dermal exposure:

TEST SITE
- Pretreatment: Approximately 24 hours before treatment the test site was shaved with an electric clipper.
- Area of exposure: back of the rat
- % coverage: 10% of the body surface
- Type of wrap if used: the skin dispersed evenly with the test item suspension was covered with a gauze-lined semiocclusive dressing fastened around the trunk with an adhesive elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin was cleaned with lukewarm water.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied: 2000 mg/kg bw

VEHICLE
- Amount(s) applied (volume or weight with unit): 4 mL/kg bw

Duration of exposure:

24 hours

Doses:

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 application and on days 7 and 14
- Necropsy of survivors performed: yes

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 observed.

Clinical signs:

other: Piloerection and hunched posture were seen, being common symptoms in acute dermal tests . On day one up to day 3 after application, a possible erythema reaction could not be evaluated because of red-staining, substance-related. The animals recovered withi

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

Conclusions:

LD50 > 2000 mg/kg bw