N,N'-(2,5-dichloro-1,4-phenylene)bis[4-[[2-chloro-5-(trifluoromethyl)phenyl]azo]-3-hydroxynaphthalene-2-carboxamide]

Endpoint summary

Description of key information

Pigment Red 242 and its structure analogues were found to non toxic upon acute oral toxicity testing in rat with doses being tested in the range of 2000 and 10000 mg/kg bw. They are 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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and OECD testing guideline compliant study

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

other: HanIbm: WIST

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., CH-4414 Füllinsdorf
- Age at study initiation: 8 weeks (males) and 10 weeks (females)
- Weight at study initiation: males: 193 - 210 g, females: 167 - 184 g
- Fasting period before study: overnight
- Housing: Groups of five
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: October 30 to November 13, 1991

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 10 ml


MAXIMUM DOSE VOLUME APPLIED: 10 ml

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 and weighing: Body weight on test days 1 (pre-administration), 8 and 15. Clinical signs: Each animal was examined for changes in appearance and behaviour four times during day 1, and daily during days 2-15.
- Necropsy of survivors performed: yes
:

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality occurred.

Mortality:

None

Clinical signs:

other: None

Gross pathology:

No findings

Interpretation of results:

practically nontoxic

Remarks:

Migrated information

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 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

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

(TS purity not specified; size of application area not reported; 4 animals used (without justification); abraded skin was treated in 2 animals)

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

before 2017-10-09

Deviations:

yes

Remarks:

4 animals used (without justification); abraded skin was treated in 2 animals; size of application area not reported

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: local supplier
- Age at study initiation: 8-11 weeks
- Weight at study initiation: 2.5-2.7 kg
- Housing: individually in elevated wire mesh cages
- Diet (e.g. ad libitum): Purina Rabbit Chow ad lib.
- Water (e.g. ad libitum): water from bottles ad lib.
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
Housing in temperature controlled rooms (no further details)

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: back, intact or abraded skin (each 2 animals; abraded with a 21 gauge bent tip
needle. The abrasions, made every 2 to 3 cm longitudinally, scratched the stratum corneum, but did
not disturb the derma or produce bleeding)
- % coverage: not reported (regarding the body weight of ca. 2500 mg and the formula BSA = 9.5 *
(body weight in g)exp(2/3), the test site should be > 180 cm2 for guideline conformity)
- Type of wrap if used: impervious material
REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm tap water
TEST MATERIAL
- Concentration (if solution): 50% w/v suspension in distilled water
- Constant volume or concentration used: yes

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

2

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations: once daily; weighing once weekly
- Necropsy of survivors performed: yes
- Other examinations performed: evaluation of local effects according to OECD Draize scheme after
25 hours, 7 and 14 days

Key result

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Abrasion (2/4 animals) had no effect on local or systemic effects

Mortality:

none

Clinical signs:

other: in 1 animal (intact skin): Diarrhea, days 3 & 4 and 7 to 10; Abdomen bloated, days 4 to 7; An orexia, days 5 and 6; Adipsia, days 5 and 6; no fecal matter in pan day 5.

Gross pathology:

One animal had yellow exudate from nose/mouth and another had bloated intestines. No abnormal
findings in the other two animals (with abraded skin).

Other findings:

Neither erythema nor edema were observed.

Interpretation of results:

GHS criteria not met

Reference 2

Endpoint:

acute toxicity: dermal

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

(TS purity not specified; size of application area not reported; 4 animals used (without justification); abraded skin was treated in 2 animals)

Justification for type of information:

See read across justification document in chapter 13

Reason / purpose for cross-reference:

read-across source

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

before 2017-10-09

Deviations:

yes

Remarks:

4 animals used (without justification); abraded skin was treated in 2 animals; size of application area not reported

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: local supplier
- Age at study initiation: 8-11 weeks
- Weight at study initiation: 2.5-2.7 kg
- Housing: individually in elevated wire mesh cages
- Diet (e.g. ad libitum): Purina Rabbit Chow ad lib.
- Water (e.g. ad libitum): water from bottles ad lib.
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
Housing in temperature controlled rooms (no further details)

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: back, intact or abraded skin (each 2 animals; abraded with a 21 gauge bent tip
needle. The abrasions, made every 2 to 3 cm longitudinally, scratched the stratum corneum, but did
not disturb the derma or produce bleeding)
- % coverage: not reported (regarding the body weight of ca. 2500 mg and the formula BSA = 9.5 *
(body weight in g)exp(2/3), the test site should be > 180 cm2 for guideline conformity)
- Type of wrap if used: impervious material
REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm tap water
TEST MATERIAL
- Concentration (if solution): 50% w/v suspension in distilled water
- Constant volume or concentration used: yes

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

2

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations: once daily; weighing once weekly
- Necropsy of survivors performed: yes
- Other examinations performed: evaluation of local effects according to OECD Draize scheme after
25 hours, 7 and 14 days

Key result

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Abrasion (2/4 animals) had no effect on local or systemic effects

Mortality:

none

Clinical signs:

other: in 1 animal (intact skin): Diarrhea, days 3 & 4 and 7 to 10; Abdomen bloated, days 4 to 7; An orexia, days 5 and 6; Adipsia, days 5 and 6; no fecal matter in pan day 5.

Gross pathology:

One animal had yellow exudate from nose/mouth and another had bloated intestines. No abnormal
findings in the other two animals (with abraded skin).

Other findings:

Neither erythema nor edema were observed.

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for acute oral or dermal toxicity under Regulation (EC) No. 1272/2008, as amended for the third time in Directive EC 618/2012.