Calcium bis[2-[(2-hydroxynaphthyl)azo]naphthalenesulphonate]

Endpoint summary

Description of key information

Studies on acute toxicity of the test item were not performed. Since all substances are metal laked salts with comparable structure and similar solubility, information on acute toxicity were derived from experimental data of a structural analogue. Five studies were performed to evaluate acute oral and inhalative  toxicity of the test substance to the rat (according OECD 401 and 403). The test substance and the analogue did not induce mortalities, abnormalities or clinical signs when applied oral. Also single administration of the analogue substance via the respiratory system did not cause health effects or mortalities. The LD50 for oral toxicity is considered to be > 5000 mg/kg bw, LC50 is > 5.24 mg/l air.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

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

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: well documented, OECD guideline and GLP conform, read acros substance

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: HOECHST AG, Kastengrund, SPF breeding colony
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 181-182 g
- Housing: groups of 5
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: not necessary (breeding at identical conditions)
- fasting period: from about 16 hours before to 3 - 4 hours after treatment

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + /- 3
- Humidity (%): 55 +/- 20
- Air changes (per hr): fully air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20 %
- Amount of vehicle (if gavage): 10 ml/kg body weight

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days 4
- Frequency of observations and weighing: Symptoms were recorded twice every day, weighed weekly
- Necropsy of survivors performed: yes

Statistics:

not necessary

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No deaths occurred during the whole study.

Clinical signs:

other: animals showed sunken flanks, stilted gait and squatting posture, all clinical signs of intoxication were reversible one day after application

Gross pathology:

The animals killed at the end of the observation period showed no macroscopically visible changes.

Other findings:

Additionally red colored feces was observed one day after application.

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

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

Adequacy of study:

supporting study

Study period:

september 1978

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: very briefly documented; test substance is a mixture; almost no administrative data

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Principles of method if other than guideline:

according H.F. Smyth et al (1962)

GLP compliance:

no

Test type:

other: Inhalations-Risiko-Test

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

source: Wiga, sulzfeld, Germany
food and water ad libitum

Route of administration:

inhalation: dust

Type of inhalation exposure:

whole body

Vehicle:

air

Details on inhalation exposure:

glassy inhalation chamber
substance enriched air (200 l/h)

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

h

Remarks on duration:

3, 10 and 30 min as well as 1, 3 and 7h

Dose descriptor:

other: mortality after inhalation

Remarks on result:

other: no mortalities after 7h inhalation

Mortality:

no

Clinical signs:

other: no signs of toxicity

Gross pathology:

without any findings

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LC50

Value:

5.24 mg/m³ air

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Read across justification

Acute toxicity of the test substance was not examined. The test item shares structural similarity to analogue substances. All of them are metal laked salts and include 1 -amino-2 -naphthol which is connected via azo bond with an aromatic sulfonic acid. The salts are poor soluble in water and octanol and dissolve most likely in an acidic environment (e.g. stomach). Therefore, it is acceptable to derive information on acute toxicity from experimental data of the analogue substance.

Procedure and observations A single dose of 5000 mg/kg bw dissolved in PEG was administrated to a group of 10 rats (5/sex/dose) by gavage (Ciba 1975). After treatment animals were observed for 14d and checked for clinical signs. All animals survived until scheduled necropsy; abnormalities or signs of toxicity were not observed. The feces of the treated animals was red stained throughout the study.

Single doses (6000 and 10.000 mg/kg bw) of the analogue were administrated to groups of 10 male and 10 female rats by oral gavage (Ciba 1973). Following dosing, the animals were observed for 7d. There were no deaths as a result of treatment with the test article. Within 2 hours after treatment rats in both dosage groups showed dyspnoea, exophthalmus, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased. The animals had recovered within 3 to 6 days.

Antoher acute oral toxicity study was conducted in 1993 (Hoechst). A single dose of 2000 mg/kg bw of a structural analogue was administrated to groups of 5 rats/sex by gavage. The animals were observed for 14 days and twice daily checked for clinical symptoms or mortalities. All animals survided until scheduled necropsy; gross necropsy did not reveal any findings. Symptoms like hunched posture or stilted gait resolved within 1 day. In addition, red stained feces was observed.

To evaluate the acute inhalative toxicity, male and female rats (5/sex/dose) were exposed for 4h to a dust aerosol of the analogue substance (range 4.25 - 6.33 mg/l air, nose only) (BASF 2010). Following dosing, the animals were observed for 14d. Examination of clinical signs and viability were performed daily, weighing on day 1, 7 and 13 after treatment. There were no deaths as a result of treatment with the test article. Clinical signs of toxicity or changes in body weight gain were not observed during the observation period. Gross necropsy was without any findings.

Similar results were determined in another inhalation study (Hoechst 1993). Animals (rats, 5/sex/dose) were exposed to dust (4.13 mg/l air, nose only) for 4h and observed for further 7 days. One male animal died accidentially during exposure; this death is not considered as treatment related. All other animals survided until scheduled necropsy; gross necropsy did not reveal any findings. Symptoms like irregular respiration, uncoordinated gait or trembling resolved within post observation period.

Discussion

Application of the test substance or an analogue via oral or inhalative route did not induce any signs of toxicity. None of the animals died due to treatment, viability and bodyweight gain were unaffected by the test article. The test item was not tested for acute dermal toxicity. With regard to the physico-chemical properties of the substance (pH, structure, solubility), the very limited skin penetration and the absence of systemic and local effects in acute oral and acute inhalation studies dermal toxicity is not likely.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for acute toxicity under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.

 

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. As a result the substance is not considered to be classified for acute toxicity under Regulation (EC) No. 1272/2008, as amended for the second time in Directive (EC 286/2011).