Pigment Yellow 214

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 17 AUG 1999 to 07 SEP 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

22 MAR 1996

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

30 SEP 1996

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

solid: particulate/powder

Details on test material:

Batch: V.N0199.064
Expiry: 09.07.2001

Test animals

Species:

rat

Strain:

other: HanIbm: WIST (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: RCC Ltd, Biotechnology & Animal Breeding Division, CH-4414 Füllinsdorf / Switzerland
- Age at study initiation: females 10 weeks, males 8 weeks
- Body weights at study initiation: females 161.7, 180.1, 181.1 g, males 223.9, 214.3, 218.8 g
- Fasting period before study: overnight 16-16.5 h
- Housing: groups of three in Makrolon type-4-cages with standard softwood bedding
- Diet: pelleted standard Kliba 3433, batch no. 39/99 rat maintainace diet, ad libitum
- Water: Community tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

PEG 300

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 g/L
- Amount of vehicle (if gavage): 10 mL

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weighing on test day 1 (pre-administration), 8 and 15, observations four times during test day 1, once daily from day 2-15
- Necropsy of survivors performed: yes
- Other examinations performed: observation of changes in appearance and behaviour

Statistics:

No statistical analysis was done as no death occurred.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: exact LD50 not determinable due to absence of adverse toxic effect

Mortality:

No deaths occurred.

Clinical signs:

No clinical sign were observed.

Body weight:

Body weight was in the normal range of animals of this strain and age

Gross pathology:

No effects observed

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Single application of the limit dose of 2000 mg test substance per kg bw did not cause lethality in 3 male and 3 female HanIbm: WIST rats during the 14 day observation period, resulting in a LD50 > 2000 mg/kg bw.

Executive summary:

3 Male and 3 female rats (HanIbm: WIST) were subjected to test acute oral toxicity according to the acute class method (OECD TG 423, Limit test). The test substance was administered by gavage at the limit dose of 2000 mg/kg bw in polyethylene glycol. No animal died within the observation period, resulting in a LD50 > 2000mg/kg bw.