Reaction mass of disodium 4-amino-3-[[4-[(2,4-diaminophenyl)azo]phenyl]azo]-5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate and disodium 4-amino-3-[[4-[(2-amino-4-hydroxyphenyl)azo]phenyl]azo]-5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate

Endpoint summary

Description of key information

Three studies differing in the route of exposure were performed to investigate the acute toxicity of the test item in male rats:

Key_acute oral_1973_Sandoz_13/73

Sup_acute dermal_1973_Sandoz_73/73

Sup_intraperitoneal_1973_Sandoz_73/73

Although each of these tests is poorly documented in terms of e.g. test design and details on test animals, the set in its entirety fulfills all requirements of a fully valid study thus allowing the conclusion that the test item exerts no acute toxicity.

 

Justification for selection of acute toxicity endpoint
No single study was selected because in view of different shortcomings in all available studies preference is given to the entirety of all available studies in order to get a fully valid data set.

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:

1973

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

poor documentation

Qualifier:

no guideline followed

Version / remarks:

Study pre-dates creation of guidelines, but a method similar to OECD 401 is likely

Principles of method if other than guideline:

Treatment of rats via gavage with subsequent observation

GLP compliance:

no

Remarks:

pre-guideline study

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

not specified

Sex:

male

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

dionized

Details on oral exposure:

- Concentration in vehicle: ca. 33 %
- Amount of vehicle (if gavage): 15 mL per kg bw

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

not specified

Control animals:

not specified

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

no mortality observed

Clinical signs:

other: none reported

Interpretation of results:

GHS criteria not met

Remarks:

Regulation (EC) no 1272/2008

Conclusions:

The acute oral median lethal dose (LD50) of the test item in male rats was determined to be greater than 5000 mg/kg body weight (Globally Harmonized Classification System - Unclassified).
The test item did not meet the criteria for classification according to Regulation (EC) No. 1272/2008.

Executive summary:

In a pre-guideline study the acute oral toxicity was investigated in white male rats.

The acute oral median lethal dose (LD50) of the test item in male rats was determined to be greater than 5000 mg/kg body weight (Globally Harmonized Classification System - Unclassified).

The test item did not meet the criteria for classification according to Regulation (EC) No. 1272/2008.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

The study is poorly documentd but the findings and conclusions are sufficiently supported by consideration of oral, dermal and intrapertoneal studies, which all show no adverse efffects even after intraperitoneal injection.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

poor documentation

Qualifier:

no guideline followed

Version / remarks:

study pre-dates creation of guidelines but a method similar to OECD TG 402 is likely

Principles of method if other than guideline:

4 hours dermal treatment with subsequent observation

GLP compliance:

no

Remarks:

pre-guideline study

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

not specified

Sex:

male

Details on test animals or test system and environmental conditions:

- Weight at study initiation: 260 - 280 g (mean 270 g)

Type of coverage:

occlusive

Vehicle:

propylene glycol

Details on dermal exposure:

TEST SITE
- Area of exposure: 25 cm2
- Type of wrap if used: gauze patch, covered with plastic

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg bw

- For solids, paste formed: moistened with propylene glycol

Duration of exposure:

4 hours

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

4 males

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: after 4 hours, 2, 6, 9, 13 and 14 days
- Frequency of weighing: after 2, 6, 9, 13, 14 days

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

no mortality observed

Clinical signs:

other: at the first two readings after 4 hours and 2 days the treated skin was discoloured by the test material. In addition, reddened skin was noted in 2 animals.

Interpretation of results:

GHS criteria not met

Remarks:

Regulation (EC) No. 1272/2008

Conclusions:

The acute oral median lethal dose (LD50) of the test item in male rats was determined to be greater than 5000 mg/kg body weight (Globally Harmonized Classification System - Unclassified).
The test item did not meet the criteria for classification according to Regulation (EC) No. 1272/2008.

Executive summary:

In a pre-guideline study the acute dermal toxicity was investigated in 4 male rats.

In a limit test the acute oral median lethal dose (LD50) of the test item in male rats was determined to be greater than 5000 mg/kg body weight (Globally Harmonized Classification System - Unclassified).

The test item did not meet the criteria for classification according to Regulation (EC) No. 1272/2008.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Additional information

In a further study the test material was administered by the intraperitoneal route. The determined LD50 was greater than 5000 mg/kg bw. No adverse effects at all were reported after i.p. injection.

Justification for classification or non-classification

For all routes of exposure - oral, dermal and intraperitoneal - the determined median lethal dose is greater than 5000 mg/kg bw.

Thus, the test item has not to be classified for acute toxicity according to Regulation (EC) no 1272/2008.