sodium hydrogen [5-(diethylamino)-2-[(2-hydroxy-4-nitrophenyl)azo]phenolato(2-)][5-hydroxy-6-[(2-hydroxy-4-nitrophenyl)azo]-1-naphthalenesulfonato(3-)]-, chromate(2-)

Endpoint summary

Description of key information

OECD TG 401 - Key Study - LD₅₀ > 2000 mg/kg bw

OECD TG 401 - Supporting Study - LD₅₀ = 3644 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

Type of information:

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

Adequacy of study:

key study

Study period:

From April 19 to May 3, 1994

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

The test was conducted by means of Read Across approach. The reliability of the source study report is 1. Further information was attached at section 13

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

In two males the allowed initial body weight was exceeded by 2 and 3 g, respectively.

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

not specified

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: Tif : RAIf (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CIBA-GEIGY Limited Animal Production 4332 Stein/Switzerland
- Weight at study initiation: 182 to 243 g
- Fasting period before study: Prior to dosing, the animals were fasted overnight.
- Housing: The animals were housed in Macrolon cages type 4, with standardized soft wood bedding (Société Parisienne des Sciures, Pantin, France).
- Diet: Rat diet (NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland) ad libitum.
- Water: ad libitum.
- Acclimation period: at least for 5 days before administration.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 55 ± 10%
- Air changes (per hr): 15 air changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hour/day light cycle.

Route of administration:

oral: gavage

Vehicle:

other: distilled water

Details on oral exposure:

VEHICLE
- Volume applied: 10 ml/kg body weight

Doses:

2000 mg/kg (males and females)

No. of animals per sex per dose:

5 per sex per dose

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: - Mortality: daily; a.m. and p.m. on working days, a.m. on weekend days: - Signs and symptoms: daily for 14 days; - Body weight: immediately before administration and on days 7 and 14.
- Necropsy of survivors performed: yes, The animals were submitted to a gross necropsy at the end of the observation period.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortalities occurred in this study

Clinical signs:

other: pilerection, hunched posture and dyspnea were seen, being common symptoms in acute tests. The animals recovered within 3 days.

Necropsies:

At necropsy, no deviations from normal morphology were found in all animals.

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 > 2000 mg/kg bw

Executive summary:

Method:

The test substance was tested for its Acute Oral Toxicity according to OECD guideline 401 and EU Method B.l.

 

Observations:

Piloerection, hunched posture and dyspnea were seen, being common symptoms in acute tests. The animals recovered within 3 days. At necropsy, no deviations from normal morphology were found in all animals.

 

Results:

LD₅₀ > 2000 mg/kg bw

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

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

Adequacy of study:

supporting study

Study period:

From October 5 to 25, 1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

The test was conducted by means of Read Across approach. The reliability of the source study report is 1. Further information was attached at section 13

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

other: Tif: RAIf

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland.
- Age at study initiation: 7-8 weeks.
- Weight at study initiation: 164-196 g.
- Fasting period before study: Prior to dosing, the animals were fasted overnight.
- Housing: The animals were kept under conventional laboratory conditions. They were caged in groups of 5 in Macrolon cages type 3 with standardized soft wood bedding (Société Parisienne des sciures, Pantin).
- Diet: Rat food, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland) ad libitum.
- Water: ad libitum.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 55 ± 15%
- Air changes (per hr): 15 air changes/h.
- Photoperiod (hrs dark / hrs light): 12 hours light/day.

Route of administration:

oral: gavage

Vehicle:

other: Distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80

Details on oral exposure:

VEHICLE
- Amount of vehicle: 10/20 ml/kg bw

Doses:

1000, 2500, 5000 mg/kg bw

No. of animals per sex per dose:

5 per sex per dose

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: - Mortality: daily, a.m. and p.m. on working days; - Body weight: on days 1, 7, 14 and at death; - Signs and Symptoms: daily.
- Necropsy of survivors performed: yes.

Statistics:

From the body weights, the group means and their standard deviations were calculated.
Where feasable, the LD50 including the 95 % confidence limit were computed by the logit method (J. Berkson, J.Am. Stat. Ass. 39. 357-65, 1944)

Sex:

female

Dose descriptor:

LD50

Effect level:

ca. 2 800 mg/kg bw

Based on:

test mat.

Remarks on result:

other: range of effect level: 1747-6358 mg/kg bw

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Based on:

test mat.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 3 644 mg/kg bw

Based on:

test mat.

Remarks on result:

other: range of effect level: 2604 - 6218 mg/kg bw. As no higher doses were applicable, the LD50 for male rats could not be calculated.

Gross pathology:

No compound related gross organ changes were observed.

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 = 3644 mg/kg bw

Executive summary:

Method:

The substance was tested for its Acute Oral Toxicity according to OECD guideline 401.

 

Observations:

At a concentrations of 2500 mg/kg bw a death occurred after a day. At 5000 mg/kg bw eight animals died after a day.

 

Results:

LD₅₀ = 3644 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 2 000 mg/kg bw

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

According to the CLP Regulation (EC n. 1272/2008), acute toxicity section, substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to numeric criteria. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE).

The oral LD50 value was established to be greater than 2000 mg/kg body weight, therefore the test substance is out of any classification limit for acute oral toxicity (oral acute toxicity Category 4: 300 < ATE ≤ 2000 mg/kg bw).