2,2'-[[3-acetamido-4-[(2-chloro-4-nitrophenyl)azo]phenyl]imino]diethyl diacetate

Endpoint summary

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:

1980-02-19 to 1980-06-27

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

BASF method

GLP compliance:

no

Remarks:

predates GLP

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Remarks:

: Wiga

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS:
- Weight at study initiation: males: 230 g/ females: 180 g
- Food: Herilan MRH-Haltung; H. Eggersmann KG
- Fasting period before study: 15-20 h before application

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

- Concentration in vehicle: 50%
- Application volume: 10 mL/kg
- Concentration of vehicle: 0.5%

Doses:

5000 mg/kg

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 weighing: day before application, day 2, 7, 13
- Frequency of observations: 1 h, 1, 2, 7, 14 days
- Necropsy of survivors performed: yes

Preliminary study:

NA

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No mortality

Clinical signs:

other: Red skin, scaly coat and hair loss were observed.

Gross pathology:

No adverse effects observed

Table 1: Bodys weight development

Day	Mean body weight [g]
	male	female
0	230	180
2-4	235	192
7	281	203
14	302	213

Interpretation of results:

GHS criteria not met

Conclusions:

Based on this study, the acute oral LD50 (gavage) in male/female rat is >5000 mg/kg bw.

Executive summary:

In an acute oral toxicity study, groups of fasted Sprague-Dawley rats (5/sex) were given a single oral dose of the test item at a dose of 5000 mg/kg bw and observed for 14 days.

 

Oral LD₅₀ =  >5000 mg/kg bw

No mortalities and no gross pathological signs have been observed during the study. Symptoms of red skin, scaly coat and hair loss were observed.

Based on these results, the test item is not considered to be classified as acute toxic according to CLP criteria.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Qualifier:

no guideline available

Principles of method if other than guideline:

Test on the basis of H.F. Smyth et al.: Am. Ind. Hyg. Ass. J. .23, 95 - 107 (1962)

GLP compliance:

no

Test type:

other: BASF method

Limit test:

yes

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

no data

Route of administration:

inhalation: vapour

Type of inhalation exposure:

not specified

Vehicle:

air

Details on inhalation exposure:

Inhalation by means of vapor saturated at 20°C for 7 hours. To achieve saturation, air (200 L/h) was fed through an approx. 5 cm deep layer of the product.

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

7 h

Concentrations:

saturation concentration

No. of animals per sex per dose:

12 rats

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: daily observation, weekly weighing
- Necropsy of survivors performed: yes

Statistics:

NA

Preliminary study:

NA

Key result

Sex:

not specified

Dose descriptor:

LC0

Based on:

test mat.

Exp. duration:

7 h

Remarks on result:

other: no effect on saturation concentration

Mortality:

no deaths

Clinical signs:

other: no effects

Body weight:

no data

Gross pathology:

no effects

Interpretation of results:

GHS criteria not met

Conclusions:

In this acute inhalation study, 7 hours inhalation of the volatile constituents of the test material did not lead to any deaths in rats (0/12).

Executive summary:

In an acute inhalation toxicity study, 12 rats were exposed by inhalation route to the volatile constituents of the test material in a saturation concentration for 7 hours. Animals were then observed for 7 days.

No deaths occurred and no clinical signs as well as gross pathology signs were observed.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The substance did not cause any mortality in acute oral and inhalation studies with rats up to 5000 mg/kg bw and air saturation level, respectively. The substance is not classifiable according to CLP criteria.