Fatty acids, dehydrated castor-oil

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP - Guideline study tested with the source substance CAS 57-10-3. In accordance to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Palmitic acid

EC Number:

200-312-9

EC Name:

Palmitic acid

Cas Number:

57-10-3

Molecular formula:

C16H32O2

IUPAC Name:

palmitic acid

Details on test material:

- Name of test material (as cited in study report): Edenor C 16 98-100 (Palmitinsäure)
- Physical state: solid white substance, crystalline structure
- Analytical purity: 98-100%

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Hannover, Germany
- Weight at study initiation: mean males 183 g, females 137 g
- Fasting period before study: 18 hours prior to administration (diet only)
- Housing: 5 animals of the same sex per cage in Makrolon R cages type III containing soft wood granulated material
- Diet: Altromin breeding diet for rats, ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 45 - 60
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

DMSO

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 500 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Purity: 99%


MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were performed immediately after dosing and 1, 4 and 24 hours thereafter, then once every 24 hours for the rest of the observation period. Individual bodyweights were measured immediately prior to dosing and then 24 h, 7 and 14 days thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

One femele rat died on day 12 after dosing, all other animals survived the 14 days observation period.

Clinical signs:

other: Clinical signs appeared approximately 20 minutes after dosing including slightly diminished activity and ruffled fur. These clinical signs completely subsided within 24 hours after dosing.

Gross pathology:

Swelling of the gastric mucosa was observed.

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