Coconut oil, reaction products with polyethylene glycol and trimethylolpropane

Acute Toxicity: dermal

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1998

Materials and methods

Test guideline

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

Test material

Test material information

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): Marlowet 4753
- Physical state: clear, yellowish liquid
- Lot/batch No.: 01/96

Test animals

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

Administration / exposure

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

Results and discussion

Effect levels

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:

other: no abnormal clinical signs were observed, no signs of erythema and oedema were observed

Gross pathology:

no test substance related findings were observed

Other findings:

- Potential target organs: not identified
- Other observations: no sex-specific differences were found

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.