coconut oil, reaction products with glycerol esters of 3,5-bis(1,1-dimethylethyl)-4-hydroxybenzenepropanoic acid

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (OECD, GLP, QAU)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

adopted February 24, 1987

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

July 31, 1992

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

425-400-6

EC Name:

-

Cas Number:

179986-09-5

Molecular formula:

UVCB substance

IUPAC Name:

methyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoate; propane-1,2,3-triol; tetradecanoic acid

Details on test material:

- Physical state: colourless liquid
- Analytical purity: 95%
- Storage condition of test material: room temperature, away from direct sunlight
No further information.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Switzerland
- Age at study initiation: 8-11 weeks
- Weight at study initiation: males: 226.1 - 235.1 g, females: 213.8 - 224.8 g
- Housing: in Makrolon type-3 cages with standard softwood bedding.
- Diet (ad libitum): pelleted standard Kliba 343, Batch no. 78/96
- Water (ad libitum): tap water
- Acclimation period: one week under laboratory conditions, after health examination.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: backs of the animals
- % coverage: 10
- Type of wrap if used: The skin was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with lukewarm tap water
- Time after start of exposure: 24

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 ml/kg bw

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

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: Four times during day 1 and once daily during days 2-14 the animals were examined for clinical signs. Mortality/viability was recorded together with clinical signs at the same time intervals.
- Frequency of weighing: Body weights were recorded on day 1 before administration and on days 8 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: based on mortality, clinical signs, body weight, gross pathology findings

Mortality:

No deaths occurred during the study period.

Clinical signs:

other: No clinical signs of toxicity were observed.

Gross pathology:

No macroscopic organ findings were observed at necropsy.