Aluminium, compound with nickel (1:1)

Endpoint summary

Description of key information

The 48 hour LD50 (oral) is calculated at greater than 31,600 mg/kg in the rat.

The 48 hour LC50 (inhalation) is calculated at greater than 2 µg/m³ in the rat.

The 48 hour LD50 (dermal) is calculated at greater than 2 mg/kg in the rabbit.

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:

other: basic information is given

Qualifier:

according to guideline

Guideline:

other: Guidelines of the Department of Transportation (D.O.T.), Code of Federal Regulations, Title 49, Part 173

GLP compliance:

not specified

Test type:

fixed dose procedure

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

- healthy albino rats
- weighing 100 - 150 gr
- animals were housed five per wire mesh suspended cage

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Based on the range finding results, five male and five female rats were gavaged in a similiar manner, see preliminary study.

Doses:

31,600 mg/kg bw

No. of animals per sex per dose:

5 animals per sex

Control animals:

no

Details on study design:

Body weights were recorded at dosing and at 48 hours for the survivors.
Clinical signs were noted immediately after dosing and at 4, 24 and 48 hours.
Animals found dead or terminated at 48 hours were subjected to a macroscopic examination of the viscera.

Statistics:

LD50 was calculated according to the method of Litchfield and Wilcoxon, Pharmacol. and Exp. Ther., 96:99, 1949

Preliminary study:

Following a 7-day period, a series of range finding doses were given by gavage to rats fasted overnight.

Doses in the range finding:

No. Dead/No. Dosed
10,000 mg/kg bw 0/2
6,320 mg/kg bw 0/2
3,980 mg/kg bw 0/2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 31 600 mg/kg bw

Based on:

test mat.

Mortality:

Results of Main Study

No. Dead/No. Dosed
31,600 mg/kg bw 0/10

Clinical signs:

other: Animals at the highest dose appeared normal after dosing.

Gross pathology:

Macroscopic changes were not observed in the viscera.

Interpretation of results:

not classified

Remarks:

Migrated information

Conclusions:

The 48 hour LD50 is calculated at greater than 31,600 mg/kg in the rat.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

31 600 mg/kg bw

Quality of whole database:

RL 2

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: basic information is given

Qualifier:

no guideline available

Principles of method if other than guideline:

no data

GLP compliance:

not specified

Test type:

acute toxic class method

Species:

rat

Strain:

Sprague-Dawley

Sex:

male

Details on test animals or test system and environmental conditions:

10 animals
provided with Purina cubed diet and tap water ad libitum
acclimation: 7 days

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

whole body

Vehicle:

clean air

Details on inhalation exposure:

dust-laden air was piped to a 56 liters all glass exposure chamber with the test animal.

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

ca. 1 h

Concentrations:

Nominal chamber concentration was 25 mg/L
Measured concentration was 2.2 mg/L

No. of animals per sex per dose:

10

Control animals:

no

Sex:

male

Dose descriptor:

LC50

Effect level:

> 2 mg/L air (analytical)

Based on:

test mat.

Exp. duration:

1 h

Mortality:

All animals were considered normal through out the 14d oberservation period.

Clinical signs:

other: No signs of toxicity were obeserved under the test conditions.

Body weight:

No abnormal body weight gains were observed.

Gross pathology:

Observed at necropsy at 14d post-exposure: Increased incidence of pulmonary abnormalities such as areas of hemorrhage and atelectasis. Was considered to be moderate.

Interpretation of results:

not classified

Remarks:

Migrated information

Conclusions:

No signs of toxicity were observed under test conditions.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LC50

Value:

2.2 µg/m³ air

Quality of whole database:

RL2

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:

1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: basic information is given

Qualifier:

according to guideline

Guideline:

other: Guidelines of the Department of Transportation (D.O.T.), Code of Federal Regulations, Title 49, Part 173

GLP compliance:

not specified

Limit test:

yes

Species:

rabbit

Strain:

other: New Zealand

Sex:

not specified

Details on test animals or test system and environmental conditions:

- healthy albino rabbits
- weighing ca. 3 kg
- animals were individually housed in stainless steel supended cages.

Type of coverage:

other: see details on study design

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

The test item was applied at 2mg/kg of body weight to the shaved skin and wrapped with an impervious band which has left in place for 24 hours.

Duration of exposure:

Animals were observed for mortality for up to 48 hours.

Doses:

2 mg / kg /bw

No. of animals per sex per dose:

5 animals / abraded skin
5 animals / intact skin

same doses to all, see above

Control animals:

no

Details on study design:

After a 7-day acclimation period, ten rabbits were clipped free of fur over the entire upper back area. Rabbits showing signs of dermal irritation or lesions were replaced. Five of the tesat sites were abraded by making a series of five parallel superficial scracthes in the dermis; the reminaing five were left intact.

Body weights were recorded at dosing.
Treatment sites were evaluated for signs of erythema or edema according to the Draize Scoring System.

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 2 mg/kg bw

Based on:

test mat.

Mortality:

No deaths were noted up to 48 hours after application.

Clinical signs:

other: No changes were noted in skin condition during the test period.

Interpretation of results:

not classified

Remarks:

Migrated information

Conclusions:

The 48 hour LD50 is calculated at greater than 2 mg/kg in the rabbit.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 mg/kg bw

Quality of whole database:

RL 2

Additional information

Test item did noch show any acute oral or dermal toxicity.

Justification for selection of acute toxicity – oral endpoint

only available study

Justification for selection of acute toxicity – inhalation endpoint

only available study

Justification for selection of acute toxicity – dermal endpoint

only available study