Bismuth(3+) neodecanoate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

The age and individual body weight of the animals were not stated. Additionally, no information about the environmental conditions was available. No details about the administration of doses and applied amount of test material were given and the test material was not sufficiently described. No justification for dose selection was available.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Reference 2

Reference Type:

other company data

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

2017-10-09

GLP compliance:

yes

Remarks:

certificate not included

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Bismuth(3+) neodecanoate

EC Number:

251-964-6

EC Name:

Bismuth(3+) neodecanoate

Cas Number:

34364-26-6

Molecular formula:

C10H19O2.xBi

IUPAC Name:

tris[(3,3,5,5-tetramethylhexanoyl)oxy]bismuthine

Details on test material:

- Density: 1.13- 1.14 mg/ml

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: New York State Rabbit Development, Hartwick, NY
- Housing: the animals were individually housed in wire mesh bottom cages in environment-controlled rooms
- Diet (e.g. ad libitum): NIH Animal Feed A (certified)
- Water (e.g. ad libitum): yes
- Acclimation period: a minimum of 5 days

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Type of wrap if used: occlusive binder, that consisted of a layer of plastic wrap and stockinette sleeve, held in place with masking tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the exposure sites were gently wiped with clean gauze to remove as much non-absorbed test article as possible
- Time after start of exposure: 24 hours

Duration of exposure:

24 hours

Doses:

2.0 g/kg bw

No. of animals per sex per dose:

5 animals/sex/dose

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: all animals were observed frequently on the day of dosing and twice daily thereafter.
- Necropsy of survivors performed: yes, all animals that died during the study and those sacrificed at termination were subjected to a gross necropsy and abnormalities were noted
- Other examinations performed: body weights were recorded initially, on days 8 and 15 or at death

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No animal died prematurely

Clinical signs:

Anorexia observed in 3/5 males and 2/5 females
Diarrhea observed in 2/5 males and 3/5 females
Soft stools observed in 3/5 males and 4/5 females
Decreased activity observed in 3/5 females
Bloody stool observed in 1/5 females
Nasal discharge observed in 1/5 females

Body weight:

No noteworthy findings

Gross pathology:

No noteworthy findings

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal LD50 of bismuth neodecanoate (Cos Cat 83) is considered to be greater than 2.0 g/kg body weight. No classification for acute dermal toxicity is required.

Executive summary:

Bismuth neodecanoate (Cos Cat 83) was evaluated for acute dermal toxicity in male and female New Zealand White rabbits. The test article was applied undiluted to each of ten rabbits at a level of 2.0 g/kg body weight. All animals survived the 15 day post-application observation period and no adverse clinical findings or body weight changes were observed. Based on these results, the acute dermal LD50 of the test article in considered to be greater than 2.0 g/kg body weight.