17,18-dihydrodinaphtho[1',2',3':3,4;3'',2'',1'':9,10]perylo[1,12-efg][1,4]dioxocin-5,10-dione

Endpoint summary

Description of key information

The LD50 (oral) was determined for male/female rats. No effects were observed up to a concentration of 5000 mg/kg bw, during a period of 14 d after application (gavage). Therefore, the LD50 is considered to be >5000 mg/kg bw. The classification criteria for CLP are not met.

The LC50 (inhalation) could not be determined for male/female rats. No effects were observed during a period of 14 d after an 8 h exposure (dust). Therefore, the classification criteria for CLP are not met.

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:

1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Herilan MRH-Haltung, Eggersmann KG, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Weight at study initiation: male (mean): 180 g, female (mean): 160 g
- Fasting period before study: 15 - 20 h prior to application

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50%
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: dispersion used for application

MAXIMUM DOSE VOLUME APPLIED: 5000 mg/kg

Doses:

5000 mg/kg

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 d
- Frequency of observations and weighing: 2-4 d, 7 d, 13 d after application
- Necropsy of survivors performed: yes

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality observed

Body weight:

Male (mean): 266 g (+ 86 g gain)
Female (mean): 196 g (+ 36 g gain)

Gross pathology:

Faeces stained blue.

Interpretation of results:

GHS criteria not met

Conclusions:

Based on an oral limit test with 5000 mg/kg bw where no mortality or any other toxicological symptoms occured within 14 d after application (gavage) in male and female rats, the test item is not classifiable according to CLP criteria.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

no guideline followed

Principles of method if other than guideline:

Inhalation risk test according to H F Smyth et al. (1962).

GLP compliance:

no

Test type:

concentration x time method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Firma Wiga, Sulzfeld, Germany
- Weight at study initiation: mean: 215 g
- Housing:
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum): ad lib.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C
- Air changes (per hr): 200 L/h

Route of administration:

inhalation: dust

Type of inhalation exposure:

whole body

Vehicle:

air

Details on inhalation exposure:

- Temperature: 20°C

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

8 h

Remarks on duration:

also determined: 3, 10, 30 min and 1, 3 h

No. of animals per sex per dose:

6

Control animals:

not specified

Key result

Sex:

male/female

Dose descriptor:

LC50

Exp. duration:

8 h

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No mortality observed.

Clinical signs:

other: No signs of toxic effect observed.

Gross pathology:

Organs without any findings.

Interpretation of results:

GHS criteria not met

Conclusions:

In an inhalation risk test performed with 6 female and 6 male rats, no mortality or other toxic effects occured after 8 h exposure (dust) and during the post exposure period of 14 d.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Justification for classification or non-classification

No adverse were observed for oral exposure and via inhalation.