Registration Dossier

Administrative data

Description of key information

The oral and dermal LD50 of Coconut oil, reaction products with polyethylene glycol and trimethylolpropane was found to be > 2000 mg/kg bodyweight. Therefore the substance is practically nontoxic.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
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
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
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
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
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
September 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: male 244 - 284 g; female 205 - 223 g
- Fasting period before study: 16 hours
- Housing: 5 animals in Makrolon cages, type III
- Diet (e.g. ad libitum): R10 Complete feed for rats ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1997-09-03 To: 1997-09-18
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: intact skin of dorsolumbar region
- % coverage: approx 10% of total body surface
- Type of wrap if used: gauze dressing and acrylastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water and absorbent paper
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.11 cm³/kg bw
Duration of exposure:
24 hours
Doses:
2000 mg/kg
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: Clinical observations: 0.5, 1, 2, 3, 4, 5, 6 and 24 h after patch removal, and thereafter once daily up to day 14; skin reactions: once daily for 14 days after patch removal; weighing: before treatment (day 0) and surviving animals were reweighed on days 7 and 14 (termination)
- Necropsy of survivors performed: yes
- Other examinations performed:
Clinical observations: In each animal a number of clinical-toxicological signs were evaluated. Any changes from the normal condition was noted (increase or decrease) and the degree of severity of any clinical symptoms was assessed.
Skin reactions: After patch removal
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
no deaths occurred in the course of the study
Clinical signs:
no abnormal clinical signs were observed, no signs of erythema and oedema were observed
Body weight:
The male rats achieved satisfactory bodyweight gains throughout the study.
One female rat showed no bodyweight gain after the first week. The other four females showed miminal to little bodyweight gain after the first weekl. At the end of the study a minimal bodyweight gain was recorded in three animals. Two animals showed quite normal bodyweight gain. Variation of bodyweight in the age / bodyweight range was judged to be a physiological finding and not substance related.
Gross pathology:
no test substance related findings were observed
Other findings:
- Potential target organs: not identified
- Other observations: no sex-specific differences were found

Table 1: Number of animals dead and with evident toxicity

Dose
(mg/kg bw)

Mortality (# dead/total)

Time range of deaths (hours)

Number with evident toxicity (#/total)

Male

Female

Combined

Male

Female

Combined

2000

0/5 

0/5

0/10 

n.a.

0/5 

 0/5

0/10

Interpretation of results:
GHS criteria not met
Conclusions:
The acute lethal dermal dose to rats of Coconut oil, reaction products with polyethylene glycol and trimethylolpropane was found to be greater than 2000 mg/kg bodyweight.
Executive summary:

A study (limit test) was performed to assess the acute dermal toxicity of Coconut oil, reaction products with polyethylene glycol and trimethylolpropane to the rat according to OECD Guidelines for Testing of Chemicals (1992), Section 4, No. 402, "Acute Dermal Toxicity" (Updated Guideline, adopted 24th Feb 1987).

A group of ten rats (five males and five females) was given a single dermal application of the test substance at a dose level of 2000 mg/kg bodyweight. The liquid test substance was administered undiluted (application volume 2.11 cm³/kg bw). The treated area was covered for 24 hours with gauze which was held in place by a semiocclusive dressing. All animals were killed and examined macroscopically on day 14, the end of the observation period.

There were no deaths and no signs of systemic reaction to treatment. After removal of the dressings 24 hours post applicationem until the end of the observation period no skin irritations were noted. The male rats achieved satisfactory bodyweight gains throughout the study, whereas the female rats showed only minimal bodyweight gains. This effect is not considered to be substance related, because variation of bodyweight in this age/bodyweight range in female rats is a physiological finding. The rats were killed and examined macroscopically on day 14, the end of the observation period. The macroscopical examination revealed no abnormalities.

The acute lethal dermal dose to male and female rats of Coconut oil, reaction products with polyethylene glycol and trimethylolpropane was found to be greater than 2000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

The oral and dermal LD50 of Coconut oil, reaction products with polyethylene glycol and trimethylolpropane was found to be > 2000 mg/kg bodyweight. Therefore the substance is practically nontoxic.

Justification for classification or non-classification

The available data on acute dose toxicity do not meet the classification criteria according to Regulation (EC) 1272/2008.