PIGMENTADDITIV RL

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 27 Feb 1989 to 13 Mar 1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (OECD TG 401), according to GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

(adopted 24 February 1987)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

(Commission Directive 84/449/EEC, adopted 25 April 1984)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Reference

Name:

Unnamed

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: HOECHST AG, Kastengrund, Germany
- Age at study initiation: males: approx. 7 weeks; females: approx. 8 weeks
- Weight at study initiation: males: mean 191 +/- 4 g; females: mean 180 +/- 8 g
- Fasting period before study: yes
- Housing: groups of 5 per sex
- Diet (ad libitum): Altromin 1324 rat diet (Altromin GmbH, Lage/Lippe, Germany)
- Water (ad libitum): tap water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 50 +/- 20
- Air changes (per hr): not stated, fully air-conditioned
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 2% starch mucilage

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20 % suspension

MAXIMUM DOSE VOLUME APPLIED:
- 10 mL/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily; weighing: weekly
- Necropsy of survivors performed: yes

Statistics:

not performed

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no animal died after application of limit dose

Mortality:

Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

No clinical signs of toxicity were observed.
The faeces of both sexes was discolored black until day 2 of study.

Body weight:

Body weight gain was within the normal range.

Gross pathology:

No macroscopic findings were observed.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study, the oral LD50 in male and female rats was > 2000 mg/kg bw.

Executive summary:

The acute oral toxicity of the test item was examined in Wistar rats (5 per sex) in a study according to OECD guideline 401 and GLP. After gavage application of 2000 mg/kg bw neither deaths nor clinical symptoms occurred.The faeces of both sexes was discolored black until day 2 of study. Development of body weight was not impaired. The animals killed at the end of the observation period showed no macroscopically visible changes. Under the conditions of this study, the oral LD50 in male and female rats was > 2000 mg/kg bw.