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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1997-07-04 until 1997-06-25
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Reaction products of coconut oil with polyethyleneglycol and 2-ethyl-2-(hydroxymethyl)propane-1,3-diol
EC Number:
640-964-5
Cas Number:
218451-68-4
Molecular formula:
not applicable because UVCB
IUPAC Name:
Reaction products of coconut oil with polyethyleneglycol and 2-ethyl-2-(hydroxymethyl)propane-1,3-diol
Details on test material:
- Name of test material (as cited in study report): reaction product of polyethylen glycol and coconut oil
- Physical state: liquid
- Analytical purity: not mentioned
- Impurities (identity and concentrations): not mentioned
- Stability under test conditions: > 1 year
- Storage condition of test material: in closed containers under exhaust hood

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: young adult
- Weight at study initiation: weight male = 143 - 145 g; female = 137 - 143 g
- Fasting period before study: approximately 16 hours
- Housing: max. 5 animals in Makrolon type III cages, group-caged by sex
- Diet (e.g. ad libitum): Ssniff R10 diet in pelletform (laboratory standard rat diet) ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70 %
- Air changes (per hr): not mentioned
- 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: 2.11 cm³ /kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Examination of clinical signs up to 6 hours after the treatment and daily, individual bodyweights were recorded on day 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: at least twice daily for any mortalities, macroscopical examinations of different tissues after killing
Statistics:
no

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
none animals died
Clinical signs:
no signs of systemic reaction to treatment
Body weight:
all animals achieved satisfactory bodyweight gains throughout the study
Gross pathology:
no abnormalities were observed

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In the study performed the dosis letalis media (LD50) to rats of Coconut oil, reaction products with polyethylene glycol and trimethylolpropane was found to be > 2000 mg/kg bodyweight.
Executive summary:

In the study performed the dosis letalis media (LD50) to rats of Coconut oil, reaction products with polyethylene glycol and trimethylolpropane was found to be > 2000 mg/kg bodyweight.