Cuprate(6-), [2-[[[[3-[[4-chloro-6-[[4-[[4-chloro-6-[(3-sulfophenyl)amino]-1,3,5-triazin-2-yl]amino]-2,5-disulfophenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5-sulfophenyl]azo]phenylmethyl]azo]-5-sulfobenzoato(8-)]-, pentasodium hydrogen, (SP-4-3)-

Endpoint summary

Description of key information

No signs of acute toxicity (oral) in male and female rats were observed. The LD50 was determined > 4000 mg/kg bw based on test material.

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:

1974

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:

no

Species:

rat

Strain:

other: Alderley Park SPF Albino strain

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Zeneca Alderley Park
- Females (if applicable) nulliparous and non-pregnant: [yes]
- Weight at study initiation: ca. 150 g
- Fasting period before study: 16 hours prior to dosing
- Housing: group housing

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE: Water
- Concentration in vehicle: 20% and 40%
- Amount of vehicle (if gavage): 10 mL/Kg bw
- Justification for choice of vehicle: water soluble dye


MAXIMUM DOSE VOLUME APPLIED: 10 mL/Kg

Doses:

2000 and 4000 mg/Kg bw

No. of animals per sex per dose:

3 males + 3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, histopathology of iver, kidney, heart, adrenals, gonads, stomach, spleen, thymus and lung in some animals

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 4 000 mg/kg bw

Based on:

test mat.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 848 mg/kg bw

Based on:

act. ingr.

Mortality:

none

Clinical signs:

2000 mg/Kg: none
4000 mg/Kg: Slight piloerection, hunched posture

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 is higher than 4000 mg/Kg bw

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Quality of whole database:

No inhalation is expected due to no vapour pressure and no particulates at an inhalable/respirable size. Therefore, no acute inhalation toxicity study was performed.

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Quality of whole database:

No uptake of the substance is expected via dermal exposure. No effects occurred in the oral toxicity study and the in vivo skin irritation study. Therefore, no acute dermal toxicity study was performed.

Justification for classification or non-classification

The LD50 in rats (oral) was determined >4000 mg/kg bw. In accordance with Regulation (EC) 1272/2008, no classification applies to Reactive Blue 160 for acute toxicity.