Magnesium bis(dinonylnaphthalenesulphonate)

Endpoint summary

Description of key information

Acute oral toxicity
Five rats/sex received a dose of ca. 2500 mg/kg bw of the test substance (PSL 1981). Two females died on day 1. Other animals survived until the end of the 14 day observation period. No effects on body weight, clinical signs and macroscopic findings were reported except in the deceased animals. The LD50 of the testsubstance is > 2500 mg/kg bw.
Studies on the analogues DNNSA and BaDNNSA showed LD50 values of > 2000 mg/kg bw and 1750 mg/kg bw respectively
Acute inhalation toxicity
Rats (5/sex) were exposed to the test substance at 2.6 mg/L by inhalation (PSL 1981). No mortality, clinical signs or effects on body weight were observed. It is therefore concluded that the LC50 is >2.6 mg/L. Analytical information on the actual concentration in the test chamber is not provided.
Acute dermal toxicity
The test substance did not induce mortality in an acute dermal toxicity study (PSL 1980). As part of the animals had an abraded skin, this represents a worst case situation. It is therefore concluded that the test substance is of low acute toxicity.
Studies on formulations of the analogues DNNSA and BaDNNSA showed LD50 values of > 1000 mg/kg bw (as active ingredient).

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:

December 2 - 26, 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Limited report, non GLP. Sufficient to allow a conclusion on the LD50 value. The information in the report is limited to the information in the summary.

Qualifier:

according to guideline

Guideline:

other: FHSLA, CFR Title 21, para. 191.1.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Taconic Farms
- Age at study initiation: not reported
- Weight at study initiation: Males: 212-290 g; Females: 200-234 g
- Fasting period before study: 18 hours prior to dosing
- Housing: individually
- Diet: Fisher Rat Chow ad libitum
- Water: ad libitum
- Acclimation period: 15 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): not reported
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

corn oil

Remarks:

in 3/10 animals

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50%

MAXIMUM DOSE VOLUME APPLIED: 5.0 mL

Doses:

2500 mg/kg bw (calculated from dosing volume)

No. of animals per sex per dose:

5 males + 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: not indicated (weighing at start and end of study reported)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Statistics:

NA

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Based on:

act. ingr.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 mL/kg bw

Based on:

test mat.

Mortality:

2 of 5 females died on day 1

Clinical signs:

none reported

Body weight:

within expected ranges (except in deceased animals)

Gross pathology:

Pulmonary Hemorrhage; Bloated Gastro-Intestinal Tract in decendents

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of the testsubstance is > 2500 mg/kg bw

Executive summary:

Five rats/sex received a dose of ca. 2500 mg/kg bw of the test substance. Two females died on day 1. Other animals survived until the end of the 14 day observation period. No effects on body weight, clinical signs and macroscopic findings were reported except in the deceased animals. The LD50 of the testsubstance is > 2500 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 500 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

No information on the actual concentration tested is available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

December 4 - 17, 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: limited reported test, non GLP. The information in the report is limited to the information in the summary.

Qualifier:

according to guideline

Guideline:

other: FHSLA 16 CFR 1500

Principles of method if other than guideline:

5 animals/sex, 3 males and 2 females with skin abrasions

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Cedar Knolls Farm
- Age at study initiation: not reported
- Weight at study initiation: Males: 2.6-3.3 kg; Females: 2.7-3.1 kg
- Fasting period before study: NA
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 17 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): not reported
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 4-5 cm2
- Type of wrap if used: elastic sleeve

REMOVAL OF TEST SUBSTANCE
- Washing (if done): none

TEST MATERIAL
- Amount(s) applied: 2 g/kg bw
- Concentration (if solution): 50%

Duration of exposure:

24 hours

Doses:

1000 mg/kg bw (calculated from dosing )

No. of animals per sex per dose:

5 males + 5 females

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: not indicated (weighing at start and end of the study)
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs

Statistics:

NA

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 1 000 mg/kg bw

Based on:

act. ingr.

Mortality:

none

Clinical signs:

none reported

Body weight:

within expected ranges

Gross pathology:

not performed

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

The LD50 of the test substance is > 1000 mg/kg bw. The substance does not need to be classified for acute dermal toxicity in view of he absence of any effects, even when applied on abraded skin (worst case)

Executive summary:

The test substance was applied on the skin of rabbits for 24 hours at 2000 mg/kg bw (as formulation of 50%). No mortality, clinical effects and effects on body weight were observed. Therefore it is concluded that the acute toxicity of the test substance is low. The LD50 is > 1000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

1 000 mg/kg bw

Additional information

The available studies contain sufficient information to be used for risk assessment and classification and labelling. All tests are performed on a 50% formulation. The effect levels are based on active ingredient, as it is not expected that the diluent has contributed to the effects if any.

Justification for selection of acute toxicity – oral endpoint
Study was conducted prior to GLP regulations but used methods generally consistent with accepted procedures. Two animals died and no further adverse effects were observed.

Justification for selection of acute toxicity – dermal endpoint
Study was conducted prior to GLP regulations but used methods generally consistent with accepted procedures. Two animals died and no further adverse effects were observed.

Justification for classification or non-classification

Based on the available studies (all indicative of low toxicity), it is concluded that the test substance does not need to be classified. The dermal LD50 of the test substance could warrant classification, but in a weight of evidence approach based on the worst case situation (abraded skin) and absence of any effects in the test with the test substance as well as based on the read-across to the acid, classification is considered not necessary.