Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well-conducted GLP study. COA is not included in the report but has been provided separately. Reliability was changed from "1" to "2" according to the ECHA guidance document "Practical guide 6: How to report read-across and categories".

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method

Test material

Constituent 1
Reference substance name:
(Z)-docos-13-enamide
EC Number:
204-009-2
EC Name:
(Z)-docos-13-enamide
Cas Number:
112-84-5
IUPAC Name:
docos-13-enamide
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Sponsor's identification: ERUCAMIDE
Description: off-white powder
Batch number: 100054

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
Animals were randomly allocated to cages. Females were nulliparous and non-pregnant. After an acclimation period of at least five days, animals were selected at random and assigned a number unique within the study. Animals were housed in groups of three by sex in solid-floor polypropylene cages with wood flakes. Except for the overnight fast immediately before dosing and for approximately three to four hours after dosing, food and tap water were available ad lib. Temperature was controlled to 19-25 °C; relative humidity was controlled to 30-70%. Rate of air exchange was at least fifteen changes per hour. Lighting was controlled to give 12 hours continuous light and 12 hours continuous darkness.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
peanut oil
Details on oral exposure:
Test material was freshly prepared as required as a suspenion in arachis oil BP. Animals were dosed once only with a dose volume of 10 ml/kg bw by gavage using a metal cannula attached to a graduated syringe. The individual volume administered to each animal was calculated according to the fasted bodyweight at the time of dosing.
Doses:
2000 mg/kg bw as suspension in peanut oil
No. of animals per sex per dose:
Three
Control animals:
no
Details on study design:
Animals were observed for deaths or overt signs of toxicity 1/2, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days. Individual bodyweights were recorded prior to dosing and seven and fourteen days after treatment. At the end of the observation period, animals were killed by cervical dislocation. All animals were subjected to gross pathological examination.
Statistics:
none

Results and discussion

Preliminary study:
not applicable
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 500 mg/kg bw
Remarks on result:
other: According to guideline, estimated LD50 is greater than 2500 mg/kg based on no mortality at 2000 mg/kg in either sex.
Mortality:
There were no deaths.
Clinical signs:
No signs of systemic toxicity were noted during the study.
Body weight:
All animals showed expected gains in bodyweight over the study period.
Gross pathology:
No abnormalities were noted at necropsy.
Other findings:
none

Any other information on results incl. tables

No mortalities or signs of systemic toxicity were observed during the observation period.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley CD (Crl: CD* (SD) IGS BR) strain rat was estimated as being greater than 2500 mg/kg bodyweight. No mortalities were noted in animals treated with 2000 mg/kg bodyweight.
Executive summary:

This study was performed to assess the acute oral toxicity of erucamide following single oral administration to the Sprague-Dawley rat. The test material was administered orally as a suspension in arachis oil BP. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy examination. There were no deaths. There were no signs of toxicity. All animals showed expected gains in bodyweight over the study period. No abnormalities were noted at necropsy. The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley rat was estimated as being greater than 2500 mg/kg. No mortalities were noted in animals treated with 2000 mg/kg bodyweight. The test material does not meet the criteria for classification according to EU labelling regulations Commission Directive 93/21/EC.