Lithium (C8-C10, branched, C9 rich, alkylnaphthalene sulphonate)

Endpoint summary

Description of key information

Acute oral toxicity
In a limit test 5 rats/sex received 2500 mg/kg bw of the test substance by gavage (PSL 1981 (1)). 3 females died with severe nasal bleedings before day 5. Macroscopic examination revealed pulmonary hemorrhage, intestinal hemorrhage, discolored kidney, necrosis of spleen and necrosis of liver in these animals. In addition bodyweight (gain) was decreased. Other animals apeared normal during the observation period. The LD50 is > 2500 mg/kg bw.
In a second imit test 5 rats/sex received 2500 mg/kg bw of the test substance by gavage (PSL 1981 (2)). 2 females died before day 3. Macroscopic examination revealed pulmonary hemorrhages In addition bodyweight (gain) was decreased. Other animals apeared normal during the observation period. The LD50 is > 2500 mg/kg bw.
Acute inhalation toxicity
Rats (5/sex) were exposed to the test substance at 5.2 mg/L by inhalation (no information on actual concentration generated) (PSL 1981). No mortality or clinical signs were observed. Body weight gain in females was decreased over the 14 -day observation period. It is therefore concluded that the LC50 is >5.2 mg/L. 
Acute dermal toxicity
Five rabbits/sex were treated dermally with 1000 mg/kg bw of the test substance for 24 hours (PSL 1981). One female died on day 1. All other animals appeared healthy until the end of the 14 day observation period. Therefore it is concluded that the test substance is of minor toxicity with an LD50 > 1000 mg/kg bw.
Studies on acute oral and dermal toxicity are available on DNNSA and BaDNNSA. These studies are indicative of low toxicity via both routes of exposure and therefore show that both DNNSA and BaDNNSA are suitable candidates for read-across.

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:

1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: limited report, non-GLP. 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.

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 Farm
- Age at study initiation: not indicated
- Weight at study initiation: males: 252-281 g ; females: 224-264 g
- Fasting period before study: 18 hours
- Housing: individually
- Diet: Fisher Rat Chow ad libitum
- Water: ad libitum
- Acclimation period: 17 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

other: oil (not further specified)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50%

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

5 mL/kg bw

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 (study seems to have been stopped after 7 days based on date of initiation and report date)
- Frequency of observations and weighing: not indicated; weighing at start and end of the study period
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Statistics:

NA

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Based on:

act. ingr.

Mortality:

2 females died on day 2; 1 female on day 5

Clinical signs:

diarrhea 2 hours after dosing in all animals
nasal bleeding in females that died

Body weight:

males: within normal ranges
females: decreased weight gain in females that died

Gross pathology:

Females that died: Pulmonary Hemorrhage (all), Intestinal Hemorrhage (all), Discolored, kidney (2/3), necrosis of Spleen (2/3), necrosis of Liver (2/3)

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the outcome of this test, the LD50 is > 2500 mg/kg bw

Executive summary:

In a limit test 5 rats/sex received 2500 mg/kg bw of the test substance by gavage. 3 females died with severe nasal bleedings before day 5. Macroscopic examination revealed pulmonary hemorrhage, intestinal hemorrhage, discolored kidney, necrosis of spleen and necrosis of liver in these animals. In addition bodyweight (gain) was decreased. Other animals appeared normal during the observation period. The LD50 is > 2500 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 500 mg/kg bw

Quality of whole database:

Information is sufficient to be used for classification and labelling

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

No study available with sufficient information on the tested concentration

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:

1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: limited report, 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

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 Knoll
- Age at study initiation: not indicated
- Weight at study initiation: males; 2.34-2.96 kg; females; 2.30-2.73 kg
- Housing: individually
- Diet: Fisher Rabbit Pellets ad libitum
- Water: ad libitum
- Acclimation period: 37 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22 °C
- Humidity (%): not indicated
- Air changes (per hr): not indicated
- 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 ( in 3 males and 2 females abrasions were made on 5-6 cm2)
- Type of wrap if used: non-permeable patch secured with tape and elastic sleeve

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

TEST MATERIAL
- Amount(s) applied : 2mL
- Concentration (if solution): 50%

Duration of exposure:

24 hours

Doses:

2 mL/kg

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; weight at start and end of the study
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Statistics:

NA

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 mL/kg bw

Based on:

test mat.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 1 000 mg/kg bw

Based on:

act. ingr.

Mortality:

1 female (skin abraded) died on day 1

Clinical signs:

none reported

Body weight:

weight loss in the female that died; other animals as expected

Gross pathology:

In the female that died: distension of stomach and gastrointestinal tract; disoloration of liver/kidney/heart
Other animals: no findings

Interpretation of results:

relatively harmless

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of the test substance is > 1000 mg/kg bw.

Executive summary:

Five rabbits/sex were treated dermally with 1000 mg/kg bw of the test substance for 24 hours. One female died on day 1. All other animals appeared healthy until the end of the 14 day observation period. Therefore it is concluded that the test substance is of minor toxicity with an LD50 > 1000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

discriminating dose

Value:

1 000 mg/kg bw

Quality of whole database:

Information is sufficient to be used for classification and labelling

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 that were observed.

Justification for selection of acute toxicity – oral endpoint
Studies were conducted prior to GLP regulations but used methods generally consistent with accepted procedures. Two studies of eqial quality are available. Both can be indicated as key-study. The results of both studies are comparable. some mortality and effects were noted at 2500 mg/kg bw.

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

Justification for classification or non-classification

Based on the outcome of the studies no classification for acute oral and acute inhalation toxicity is proposed.

For dermal toxicity, some mortality was observed at 1000 mg/kg bw, but in addition no toxicity was seen. The substance was tested in a formulation (exposure to 2000 mg/kg as formulation). The diluent material is not expected to have contributed to the effects. Therefore it is proposed not to classify the substance for acute dermal toxicity.