Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
21-08-2012 to 12-09-2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Qualifier:
according to
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: extremely viscous liquid
Details on test material:
test substance identification: Fatty acids, tall-oil, reaction products with fatty acids C16-18 and C18-unsatd, branched and linear, diethylenetriamine and methylhydrogen maleate
Description : dark amber coloured extremely viscous liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxon, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 152-160 g
- Fasting period before study: 24 hours before dosing and 3-4 hours thereafter
- Housing: 4/cage in solid-floor polypropylene cages furnished with woodflakes
- Diet: 2014C Teklad Global Rodent diet supplied by Harlan Laboratories UK Ltd., Oxon, UK ad libitum
- Water: ad libitum
- Acclimation period: >5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25°C
- Humidity (%): 30-70%
- Air changes (per hr): >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: 200 mg/mL
DOSE VOLUME APPLIED: 10 mL/kg

Doses:
2000 mg/kg bw
No. of animals per sex per dose:
1 female in the pre-test (2000 mg/kg bw), 4 females in the main study
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality twice daily; body weight on day 0 (before treatment), day 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs ½, 1, 2, and 4 hours after dosing and daily thereafter
Statistics:
NA, limit test

Results and discussion

Preliminary study:
No mortality at 2000 mg/kg bw
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
none
Body weight:
within normal ranges
Gross pathology:
no effects

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 after oral application of the test substance is > 2000 mg/kg bw
Executive summary:

Female rats (n=5) received a single oral dose of 2000 mg/kg bw of the test substance. No effects on clinical signs, body weight and macroscopic examinations were found. No mortality was observed. The LD50 is > 2000 mg/kg bw.