PIGMENTADDITIV RL

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 02 Mar 1989 to 16 Mar 1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (OECD TG 402), 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 402 (Acute Dermal Toxicity)

Version / remarks:

(adopted 24 February 1987)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

(Council 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. 8 weeks; females: approx. 9 weeks
- Weight at study initiation: males: mean 200 +/- 5 g; females: mean: 193 +/- 4 g
- Fasting period before study: no
- Housing: individually
- 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

Type of coverage:

occlusive

Vehicle:

polyethylene glycol

Remarks:

(PEG 400 as moistener)

Details on dermal exposure:

TEST SITE
- Area of exposure: 30 cm2
- % coverage: 100 %
- Type of wrap if used: aluminium foil, fixed with an elastic plaster bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): about 0.4 g
- For solids, paste formed: yes, with polyethylene glycol 400 (ratio: 1 g test item+ 0.8 mL PEG 400)

Duration of exposure:

24 h

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.
During the first five days of the observation period the treated skin surface exhibited a violet colour.

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 dermal LD50 in male and female rats was > 2000 mg/kg bw.

Executive summary:

The acute dermal toxicity of the test item was examined in Wistar rats (5 per sex) in a study according to OECD guideline 402 and GLP. After 24 h application of 2000 mg/kg bw neither deaths nor symptoms occurred till the end of the 14 days observation period. During the first five days of the observation period the treated skin surface exhibited a violet colour. 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 dermal LD50 in male and female rats was > 2000 mg/kg.