Fatty acids, C16-18 (even numbered), aluminum salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

08 - 25 Jan 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP - Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, München, Germany

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C16-18 (even numbered), aluminum salts

EC Number:

939-582-4

Cas Number:

1471315-26-0

Molecular formula:

Not applicable (UVCB substance)

IUPAC Name:

Fatty acids, C16-18 (even numbered), aluminum salts

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Fatty acids, tallow, hydrogenated, aluminium salts
- Physical state: white solid powder
- Analytical purity: 84.33%
- Impurities (identity and concentrations): ash content 9.17%; humidity 0.75%; free fatty acids 14.13%; water-soluble salts 0.61%; aluminium 4.13%
- Purity test date: 2012-05-04
- Lot/batch No.: C200752-001
- Expiration date of the lot/batch: 2014-02-14
- Storage conditions: at room temperature
- Other: CAS 91770-05-7

Test animals

Species:

rat

Strain:

other: WISTAR Crl: WI (Han)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Age at study initiation: 8 - 9 weeks
- Weight at study initiation: step 1: 156 - 160 g; step 2: 137 - 145 g
- Fasting period before study: animals were fasted 16 - 19 h prior to administration (access to water was permitted) until 4 h after dosing.
- Housing: animals were kept in groups in IVC cages, type III, polysulphone cages on Altromin saw fibre bedding (lot No. 160812)
- Diet: Altromin 1234 maintenance diet for rats and mice (lot No. 0636), ad libitum
- Water: tap water (municipal residue control) sulphur acidified to a pH of approx. 2.8
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: 3 Jan To: 25 Jan 2013

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

cotton seed oil

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: the vehicle was chosen due to it´s known non-toxic properties and the insolubility of the test substance in water.
- Lot/batch no. (if required): MKBJ0602V


MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

DOSAGE PREPARATION (if unusual):
The test substance was ground in a mortar prior to dissolving in cotton seed oil. Homogeneity of the suspension was maintained by vortexing during the administration procedure.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: according to the toxic class method

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 (step 1)
3 (step 2)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed several times on the day of dosing and daily thereafter and individual body weights were determined on Day 1 prior to treatment and on Day 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology, other: changes in skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous system and behaviour pattern. Special emphasis was directed on tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured during the study period.

Clinical signs:

other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.

Gross pathology:

Necropsy revealed no substance-related findings despite acute injection of blood vessels in the abdominal region caused by euthanasia injection.

Other findings:

No other finfings are reported in the study report.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified