PIGMENTADDITIV RL

Endpoint summary

Description of key information

In male and female rats the oral LD50 is > 2000 mg/kg bw. LD50 in male and female rats after dermal exposure was determined to be > 2000 mg/kg bw. No study on acute toxicity after inhalation exposure is available. 

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

(adopted 24 February 1987)

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

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

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

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

Reliable LD50 > 2000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Quality of whole database:

This information is not available

Acute toxicity: via dermal route

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

(adopted 24 February 1987)

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

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

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

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

Reliable LD50 > 2000 mg/kg bw

Additional information

Reliable studies exist for both oral and dermal exposure, indicating no toxicity at the limit dose (2000 mg/kg bw) tested in these studies. Oral: A reliable study (RL1, according to guideline and GLP) did not observe mortality or toxic effects at 2000 mg/kg bw in male and female rats (Hoechst, 1989). Therefore the LD50 is > 2000 mg/kg bw. Dermal: A reliable study (RL1, according to guideline and GLP) did not observe mortality or toxic effects at 2000 mg/kg bw in male and female rats (Hoechst, 1989). Therefore the LD50 is > 2000 mg/kg bw.

Inhalation: No study is available

Justification for selection of acute toxicity – oral endpoint
Guideline study (OECD TG 401), according to GLP

Justification for selection of acute toxicity – dermal endpoint
Guideline study (OECD TG 402), according to GLP

Justification for classification or non-classification

No classification on acute oral and dermal toxicity according to Regulation (EC) No 1272/2008 and Council Directive 67/548/EEC is required as the oral and dermal LD50 is > 2000 mg/kg bw. No information is available for inhalation exposure.