N,N'-(2,5-dimethyl-1,4-phenylene)bis[4-[(5-chloro-2-methylphenyl)azo]-3-hydroxynaphthalene-2-carboxamide

Endpoint summary

Description of key information

Pigment Red 262 was found to non toxic upon acute oral toxicity testing in rats with an LD50 above 5000 mg/kg bw. 
It is non toxic upon acute skin contact based on experimental data with Pigment Red 144 obtained with rabbits and 
based on the physico-chemical properties, which indicate absent or very low skin permeability.  

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:

1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and OECD guideline compliant study

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: males: 8 weeks, females: 9 weeks
- Weight at study initiation: ma 1es : 199 - 230 g, females: 169 - 179 g
- Fasting: overnight (12 - 18h)
- Housing: five rats per cage
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
Temperature (°C): 20+-3 degrees centigrade
- Humidity (%): 40-70 %,
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 1988-08-29 To:1988-09-12

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 5000 mg/20 ml
- Amount of vehicle (if gavage): 20 ml/kg bw

Doses:

5000 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 and weighing: Clinical signs and mortality: Four times during test day 1, and daily during days 2-15; Body weights Test days 1 (pre-administration) , 8 and 15.
- Necropsy of survivors performed: yes

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality occurred

Mortality:

none

Clinical signs:

other: sedation, dyspnea (males), hunched posture, ruffled fur. All rats had recovered within six observation days.

Gross pathology:

No findings

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

Reliable and valid.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Value:

mg/kg bw

Additional information

Pigment Red 262 (CAS 79665-24-0; 782 g/mol)

Pigment Red 262 was evaluated in a GLP and OECD 423 compliant study in rats with the limit dose of 5000 mg/kg bw (RCC 1988). Clinical signs involved sedation, dyspnea (males), hunched posture, ruffled fur. All rats recovered within six observation days. No mortality occurred.

 

 

 

 

 

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The substance is not classified for acute oral or dermal toxicity under Regulation (EC) No. 1272/2008, as amended for the third time in Directive EC 618/2012.