[8-[(p-aminophenyl)azo]-7-hydroxy-2-naphthyl]trimethylammonium chloride

Endpoint summary

Description of key information

LD50 was considered to be between 2000 and 4000 mg/kg bw when CYF male and female rats were treated with Basic Brown 16. Therefore, Basic Brown 16 cannot be classified as per the criteria of CLP regulation for acute oral toxicity.

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:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Data is from opinions on health and safety risks (chemical, biological, mechanical and other physical risks)

Qualifier:

according to guideline

Guideline:

other: refer below principle

Principles of method if other than guideline:

Study conduct to determine the acute toxic effects by oral route of test substance Basic Brown 16 in male and female CFY rat.

GLP compliance:

no

Test type:

other: no data

Limit test:

no

Species:

rat

Strain:

other: CFY

Sex:

male/female

Details on test animals or test system and environmental conditions:

No data available

Route of administration:

oral: gavage

Vehicle:

other: methylcellulose

Details on oral exposure:

VEHICLE- Concentration in vehicle:0, 0.1, 1.0, 2.0 and 4.0 g/kg bw in volumes of 1.0 to 40 ml/kg- Amount of vehicle (if gavage):40 ml/kg

Doses:

0, 0.1, 1.0, 2.0 and 4.0 g/kg bw

No. of animals per sex per dose:

2 male + 2 female rats

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days - Frequency of observations and weighing:daily- Necropsy of survivors performed: no- Other examinations performed: mortality and clinical abnormalities,Body weights and macroscopic observations.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 000 - 4 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no mortalities

Clinical signs:

other: Signs of reaction to treatment, observed shortly after dosing, included piloerection and abnormal body carriage (hunched posture).

Gross pathology:

No abnormalities were recorded at autopsy.

Interpretation of results:

not classified

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

The LD50 was reported to be between 2000 and 4000 mg/kg bw.

Executive summary:

Groups of 2 male and 2 female rats received a single oral dose of 0.1, 1.0, 2.0 or 4.0 g/kg bw. Control animals received 1% aqueous methylcellulose in a volume of 40 ml/kg. The animals were observed daily for 14 days for mortality and clinical abnormalities. Body

weights and macroscopic observations were recorded, but histological examinations were not performed.

Within one week of dosing, all animals treated at 4.0 g/kg bw died, one female died after a dose of 1.0 g/kg and one after a dose of 2.0 g/kg bw; no male rats died at doses of 1 or 2 g/kg bw. There were no mortalities at 0.1 g/kg. Signs of reaction to treatment, observed shortly after dosing, included piloerection and abnormal body carriage (hunched posture). The bodyweight gain of surviving treated animals was similar to controls and no abnormalities were recorded at autopsy.

The LD50 was reported to be between 2000 and 4000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

Available data is from Scientific Committee on Consumer Safety report for Basic Brown 16 (2012) and from the klimisch rating 4 for both target and its read across

Additional information

Acute oral toxicity:

In a opinion given by Scientific Committee on Consumer Safety for Basic Brown 16 (2012), a study report by COLIPA given acute oral toxicity on CYF male and female rats by using Basic Brown 16 in the concentration of 0, 100, 1000, 2000 and 4000 mg/kg bw in 1 % methylcellulose orally by gvage and observed for 14 days. Within one week of dosing, all animals treated at 4000 mg/kg bw died, one female died after a dose of 1000 mg/kg and one after a dose of 2000 mg/kg bw; no male rats died at doses of 1000 and 2000 mg/kg bw. There were no mortalities at 100 mg/kg. Signs of reaction to treatment, observed shortly after dosing, included piloerection and abnormal body carriage (hunched posture). The body weight gain of surviving treated animals was similar to controls and no abnormalities were observed at autopsy. Therefore, LD50 was considered to be between 2000 and 4000 mg/kg bw when CYF male and female rats were treated with Basic Brown 16.

Similar to above reference, in 2003, a study report by COLIPA given acute oral toxicity on CF-1 male mice by using Basic Brown 16 in the concentration of 5010, 6310, 7940 and 10000 mg/kg bw in distilled water by oral gavage and observed for 7 days. 9 animals were died at 10000 mg/kg bw, 5 at 7900 mg/kg bw and 1 at 6310 mg/kg bw. Decrease activity, increased respiratory rate and tremors were observed in treated mice. Therefore, LD50 was considered to be 7800 mg/kg bw when CF-1 male mice were treated with Basic Brown 16.

Similar to above reference, in 2011 for read across Basic Red 76, acute oral study was carried in Wistar male and female rats by using Basic Red 76 administered by oral gavage to a group of three male and female rats at 2000 mg/kg bw and observed for day 15. No mortality occurred. Hunched posture was noted in one female and 3 male on day 1. Red staining of the back and/or snout and/or head was noted in 1 female and 2 male between days 1 and 11. Red and/or yellow faeces and/or yellow urine were seen among the animals on days 2 and/or 3. The mean body weight gain over the study period was considered to be normal. No abnormalities were found at macroscopic post mortem examination of the treated male and female rats. Therefore, LD50 was considered to be greater than 2000 mg/kg bw when Wistar male and female rats were treated with Basic Red 76 orally.

Similar to above reference, in 2003 for read across Basic Red 76, acute oral study was carried in CFY male and female rats by using Basic Red 76. Groups of 2 male and 2 female rats received a single oral dose of Arianor Madder Red at a dose range from 100 to 16000 mg/kg bw. Control animals received vehicle alone. The animals were observed for 14 days for mortality and clinical abnormalities. Body weights and macroscopic observations were recorded, but histological examinations were not performed. No mortalities were reported in treated rats. Signs of reaction to treatment included lethargy, piloerection, decreased respiratory rate and abnormal body carriage (hunched posture). Red staining of the urine and faeces was observed at 8000 and 16000 mg/kg body weight. Therefore, LD50 was considered to be greater than 16000 mg/kg bw when CFY male and female rats were treated with Basic Red 76 orally.

Similar to above reference, in 2003 for read across Basic Red 76, acute oral study was carried on CF1 male mice by using Basic Red 76. Groups of 3 male mice received a single oral dose of Basic Red 76 at dose levels of 1000, 2510 and 5010 mg/kg bw, 10 male mice received the top dose of 10000 mg/kg bw. The animals were observed for 14 days for mortality and clinical abnormalities. Body weights and macroscopic observations were recorded, but histological examinations were not performed. No mortalities were observed. Following treatment lethargy and breathing disorders were observed in mice at 10000 mg/kg bw only. Therefore, LD50 was considered to be greater than 10000 mg/kg bw when CF1 male mice were treated with Basic Red 76 orally.

Similar to above reference, in 2003 for another read across Basic brown 17, CFY male/female rats were exposed orally to Basic brown 17 in the concentration of 0, 100, 1000, 4000, 8000 and 16000 mg/kg body weight. The test compound was prepared as 10 and 40 % (w/v) suspensions in 1% aqueous methylcellulose. Signs or reaction to treatment, observed shortly after dosing, included lethargy, piloerection, decreased respiratory rate and abnormal body carriage (hunched posture). Mortality was observed in 2 male rats and 1 female rat in 16000 mg/kg body weight. Therefore, LD50 was considered to be between 8000 and 16000 mg/kg bw when CFY male/female rats were treated with Basic brown 17.

Similar to above reference, in 2003 for another read across Basic brown 17, CF1 male mouse were exposed orally to Basic brown 17 in the concentration of 1000, 2510 and 5010 mg/kg bw administered at a volume of 0.2 ml/10 g body weight and observed for 7 days. No mortalities were observation in treated mice. Therefore, LD50 was considered to be greater than 5000 mg/kg bw when CF1 male mouse were treated with Basic brown 17.

Thus, based on the basis of available values for target Basic Brown 16 (26381 -41 -9) and two read across Basic Red 76 (CAS no. 68391 -30 -0) and Basic brown 17 (CAS no. 68391 -32 -2), it can be concluded that the substance cannot be classified as per the criteria of CLP regulation for acute oral toxicity. Available data is from Scientific Committee on Consumer Safety report for Basic Brown 16 (2012) and from the klimisch rating 4 for both target and its read across.

Justification for selection of acute toxicity – oral endpoint
The LD50 was reported to be between 2000 and 4000 mg/kg bw. and the study is resent

Justification for classification or non-classification

it can be concluded that the substance Basic Brown 16 and two read across Basic Red 76 and Basic brown 17

cannot be classified as per the criteria of CLP regulation for acute oral toxicity. Available data is from Scientific Committee on Consumer Safety report for Basic Brown 16 (2012) and from the klimisch rating 4 for both target and its read across.