Ethanaminium, N-[4-[[4-(diethylamino)phenyl][4-(ethylamino)-1-naphthalenyl]methylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl-, molybdatetungstatephosphate

Endpoint summary

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:

1 Nov 1993 - 23 Nov 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes (incl. QA statement)

Limit test:

yes

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 0151N BLUE LUMIERE PTM
- Storage: room temperature
- Physical Appearance: dark blue powder

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Ltd.
- Age at study initiation: 5 – 8 weeks old
- Weight at study initiation: males: 162 – 171g, female: 143 – 160g
- Fasting period before study: overnight before and 2 hours after dosing
- Housing: housed in groups of up 5 by sex in solid floor polypropylene cages furnished with wood flakes
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 21
- Humidity (%): 45 - 54
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

- Dose level: 2000 mg/kg
- Concentration: 200 mg/mL
- Dose volume: 10 mL/kg

Doses:

2000 mg/kg

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:
Animals were observed for deaths or overt signs of toxicity 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days.
Individual bodyweights were recorded prior to dosing on day 0 and on days 7 and 14 or at death
- Necropsy of survivors performed: yes

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

1 male rat one day after dosing

Clinical signs:

other: Dark blue-coloured liquid discharged from the anus was noted in all males and one female during the day of dosing. Dark blue-coloured staining of the fur was commonly noted. Surviving animals recovered one day after dosing except for four females which ap

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral median lethal dose (LD50) of the test item in the Sprague-Dawney strain rat was found to be greater than 2000mg/kg bodyweight.

No symbol and risk phrase are required according to EEC labelling regulations

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

Guideline study conducted in 2017

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

LD50 for acute oral toxicity test >2000 mg/kg/day,

An acute toxicity study by the dermal route is not appropriate since the physicochemical and toxicological properties suggest no potential for a significant rate of absorption through the skin.

An acute toxicity study by inhalation is not appropriate taking into account the vapour pressure of the substance and the possibility of exposure to aerosols, particles or droplets of an inhalable size.