Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

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
Study period:
24 Jan - 12 Feb 2002
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study with acceptable restrictions (no analytical purity data available)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
adopted in 1996
Deviations:
yes
Remarks:
no analytical purity reported
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
adopted in 1996
Deviations:
yes
Remarks:
no analytical purity reported
GLP compliance:
yes
Remarks:
Department of health of the government of the United Kingdom, UK
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Fatty acids, C16-18 and C18-unsatd., branched and linear, esters with trimethylolpropane
Cas Number:
403507-18-6
Molecular formula:
not applicable, substance is a UVCB
IUPAC Name:
Fatty acids, C16-18 and C18-unsatd., branched and linear, esters with trimethylolpropane
Details on test material:
- Name of test material (as cited in study report): only trade name given
- Physical state: dark amber slightly viscous liquid
- Analytical purity: no data
- Storage condition of test material: room temperature in the dark

Test animals

Species:
rat
Strain:
other: Sprague-Dawley CD (Crl: CD IGS® BR)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd, Kent, UK
- Age at study initiation: approximately 8 weeks of age
- Weight at study initiation: 226 – 237 (males) and 211 – 232 (females)
- Fasting period before study: overnight immediately before dosing and for approximately three to four hours after dosing.
- Housing: three animals of the same sex per cage in solid-floor polypropylene cages furnished with wood flakes.
- Diet: Certified Rat and Mouse diet (Code 5LF2), PMI Nutrition International, Nottingham, UK, ad libitum (with exception to fasting period)
- Water: mains drinking water, ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2.15 mL/kg

Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
other: not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed daily for mortality or evident signs of toxicity ½, 1, 2, and 4 hours after dosing and thereafter for fourteen days. Individual body weights were determined prior to dosing and seven and fourteen days after exposure
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study period.
Clinical signs:
No clinical signs of toxicity were observed up to the end of the 14-day observation period.

Body weight:
No effect on body weight was noted.
Gross pathology:
Necropsy examination revealed no substance-related findings.

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