Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1990-11-13 to 1990-11-27
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP - Guideline study, tested with the source substance methyl laurate (CAS NO. 111-82-0). 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:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Laurinsäuremethylester
- Physical state: liquid, colourless
- Analytical purity: 98 - 100%
- Impurities (identity and concentrations): Not given
- Purity test date: Not given
- Lot/batch No.: From tank 323; produced 27. - 29.06.1990
- Expiration date of the lot/batch: Not given
- Storage condition of test material: RT

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann GmbH, Germany
- Age at study initiation: Approx. 10 weeks
- Weight at study initiation: Mean weights: Male: 176 g, Female: 155 g
- Housing: Groups of 5 animals in Makrolon Type 3 cages
- Fasting period before study: 16 h before until 3 h after dosing
- Diet (e.g. ad libitum): ad libitum (Altromin Maintainance diet 1324)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23
- Humidity (%): 45-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20% (g/v)
- Amount of vehicle (if gavage): 10 mL/kg

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Maximum dose recommended
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality/Viability twice daily; body weight on days -1, 1, 2, 7 and 14
- Necropsy of survivors performed: yes, Macroscopic examintion of the cranial, thoracic and visceral cavities
Statistics:
Not applicable

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: rat
Mortality:
No mortality
Clinical signs:
No symptoms observed
Body weight:
Normal body weight gain
Gross pathology:
Male: No findings considered to be related to treatment
Female: One animal with strong hydrometra

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU