Calcium bis[4-[[1-[[(2-methylphenyl)amino]carbonyl]-2-oxopropyl]azo]-3-nitrobenzenesulphonate]

Endpoint summary

Description of key information

Oral: LD50 (m/f) > 10 000 mg/kg bw, similar to OECD TG 401, no GLP, rat, 1972, K2

Dermal: Read-across, LD50 (m/f) > 2 000 mg/kg bw, according to OECD TG 402, GLP-compliance, rat, 2011, K1

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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

no guideline followed

Principles of method if other than guideline:

similarities to OECD guideline 401

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: CFE (RAC, SPF) strain

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: /
- Age at study initiation: /
- Weight at study initiation: 126 - 139 g
- Fasting period before study: /
- Housing: groups of 5 in macrolon cages
- Diet (e.g. ad libitum): Nafag ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1
- Humidity (%): 55 +/- 5
- Air changes (per hr): /
- Photoperiod (hrs dark / hrs light): 14h

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

0.5 % in tap water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25%
- total volume: 20 ml/kg bw

MAXIMUM DOSE VOLUME APPLIED: 10.000 mg/kg bw

Doses:

5000 and 10000 mg/kg bw

No. of animals per sex per dose:

5000 mg/kg bw : 5 per sex and dose
10000 mg/kg bw : 3 males and 2 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 8d
- Frequency of observations and weighing: /
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology

Statistics:

no

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

no martality

Clinical signs:

other: no clinical symptoms

Other findings:

yellow stained feces

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral LD50 was established to be > 10000 mg/kg bw.

Executive summary:

To evaluate the acute oral toxicity, single doses of 5000 and 10.000 mg/kg bw of the test article in 0.5 % carboxymethyl cellulose were administrated to groups of male and female rats (CFE (RAC, SPF) strain) by oral gavage. Following dosing, the animals were observed for 8d. There were no deaths observed after treatment with the test article. Clinical signs of toxicity or changes in body weight gain were not observed. Gross necropsy was without any findings.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

10 000 mg/kg bw

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:

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

Adequacy of study:

key study

Justification for type of information:

Further information are included as attachment in chapter 13 of the IUCLID dossier.

Reason / purpose for cross-reference:

read-across source

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

not determinable due to absence of adverse toxic effects

Reference 2

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Breeding farm VELAZ S.f.O., Kolec u Kladna, Czech Republic, RCH CZ 21760152
- Weight at study initiation: males 258 g, females 189 g
- Housing: singly
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30 - 70
- Air changes (per hr): /
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: back
- % coverage: 10
- Type of wrap if used: semiocclusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): water
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Concentration (if solution):
- Constant volume or concentration used: unchanged substance, constant dose level, volume individual
- For solids, paste formed: no

VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:

Duration of exposure:

24h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weighing before application, 8th and 15th day of study, observation daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Statistics:

not applicable

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

no

Clinical signs:

other: no

Gross pathology:

no abnormalities

Interpretation of results:

GHS criteria not met

Conclusions:

According to the results of study, the value of LD50 (dermal) of the test substance is higher than 2000 mg/kg bw for rats of both sexes.

Executive summary:

The substance was tested for acute dermal toxicity using Wistar rats. Two groups of animals (5 males and 5 females) received a single dose of 2000 mg/kg bw. The test material was applied onto shaved dorsal skin for 24 hours. The test animals were observed 14 days after exposure of the test substance, afterwards they were sacrificed, and the necropsy for macroscopic examination of the organs was performed. The test item did not cause mortality. Clinical signs or macroscopic changes were not observed.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

Acute oral toxicity

To evaluate the acute oral toxicity, single doses of 5000 and 10.000 mg/kg bw of the test article in 0.5 % carboxymethyl cellulose were administrated to groups of male and female rats (CFE (RAC, SPF) strain) by oral gavage. Following dosing, the animals were observed for 8d. There were no deaths observed after treatment with the test article. Clinical signs of toxicity or changes in body weight gain were not observed. Gross necropsy was without any findings.

 

 

Acute dermal toxicity

As no reliable data on acute dermal toxicity was available for the test substance, a read-across to a study with a structural anologue (CAS 12286-65-6) was performed. 

The structural analogue substance was tested for acute dermal toxicity using Wistar rats. Two groups of animals (5 males and 5 females) received a single dose of 2000 mg/kg bw. The test material was applied onto shaved dorsal skin for 24 hours. The test animals were observed 14 days after exposure of the test substance, afterwards they were sacrificed, and the necropsy for macroscopic examination of the organs was performed. The test item did not cause mortality. Clinical signs or macroscopic changes were not observed.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. No mortality occurred at the limit dose of 2000 mg/kg bw. 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 fifteenth time in Regulation (EC) No. 2020/1182.