Reaction product with n-butanol of high-boiling stream resulting from the hydroxylation, oxidative cleavage and hydrolysis of vegetable oil saturated and unsaturated C16-C22 triglycerides.

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: Recent and well documented OECD guideline study following GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction product with n-butanol of high-boiling stream resulting from the hydroxylation, oxidative cleavage and hydrolysis of vegetable oil saturated and unsaturated C16-C22 triglycerides.

EC Number:

940-822-5

IUPAC Name:

Reaction product with n-butanol of high-boiling stream resulting from the hydroxylation, oxidative cleavage and hydrolysis of vegetable oil saturated and unsaturated C16-C22 triglycerides.

Test material form:

liquid: viscous

Details on test material:

Batch no. P23_11_12 + P25_07_13
Expiry date 23 May 2014
Storage conditions: room temperature, protected from light.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Species and strain:
Rat, Hsd: Sprague Dawley SD

Sex:
Males and females (nulliparous and non-pregnant)

Age:
6 to 8 weeks old

Weight at order:
176 to 200 grams

Supplier:
Harlan Italy s.r.l., San Pietro al Natisone (UD), Italy

Weight range at arrival:
171 to 181 grams

Acclimatisation period:
At least 5 days

Animals per cage:
Up to 5 of one sex to a cage

Housing:
Clear polysulphone H-Temp solid bottomed cages (Techniplast Gazzada S.a.r.l., Buguggiate, VA, Italy) measuring 59.53820 cm during acclimatisation
period and 42.526.618.5 cm during the study with stainless steel mesh lid and floor.

Cage control:
Daily inspected and changed as necessary (at least 3 times/week)

Water:
Drinking water supplied to each cage via a water bottle

Water supply:
Ad libitum

Diet:
4 RF 18 (Mucedola S.r.l., Via G. Galilei, 4, 20019, Settimo Milanese (MI) Italy)

Diet supply:
Ad libitum throughout the study

Room lighting:
Artificial (fluorescent tubes), daily light/dark cycle of 12/12 hours

Air changes:
Approximately 15 to 20 air changes per hour

Temperature range:
22 ± 2 °C

Relative humidity range:
55 ± 15%

Administration / exposure

Type of coverage:

semiocclusive

Details on dermal exposure:

Selection/Allocation:
Random at arrival. The body weight of each individual was within 20% of the mean and within the range of 200-300 grams. Animals were unequivocally numbered within the study. The animal number together with the study number ensured a unique animal numbering for any study employing computerised data collection.

Animal identification:
Animals were permanently identified, following arrival, by a combination of ear notch (units) and tattoo on the hind feet. Males and females were
identified by even and odd numbers, respectively.

Frequency of treatment:
Animals were dosed once only on Day 1.

Treatment area preparation:
On the day before dosing (Day –1), a single area was clipped free of hair (by an electric clipper equipped with a suitable blade) on the dorsal surfaces of the trunk of each animal (approximately 10% of body surface). Care was taken to avoid damage to the skin.

Dose calculation:
On the day of dosing (Day 1), the aliquots were weighed according to the body weight of each animal measured prior to dosing.

Dosing procedure:
An aliquot of the supplied test item was spread evenly over an area of approximately 10% of the body surface area. A patch of surgical gauze
covered by a strip of synthetic film was placed over the treated site and the whole assembly held in place by encircling the trunk of the animal with a
length of elastic adhesive bandage, this forming a semi-occlusive barrier.

Washing procedure
After exposure, the adhesive bandage and gauze patch were removed. The treatment area was cleaned by gentle swabbing of the skin with cotton wool soaked with lukewarm water.

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

A single group of 5 male and 5 female animals was dosed at a level of 2000 mg/kg.

Control animals:

not required

Details on study design:

In vivo observations

Mortality and morbidity:
Throughout the study all animals were checked twice daily.

Clinical signs:
Animals were observed for clinical signs as indicated below (and daily after a total of 14 days)

Day of dosing
– Session 1: on dosing
– Session 2: approximately 1 hour after dosing
– Session 3: 2 hours after dosing
– Session 4: 4 hours after dosing

Body weight
All animals were weighed at allocation to the study (Day -1), on the day of dosing (Day 1) and on Days 8 and 15. Body weight change calculated for Days 8 and 15 of the dosing phase was relevant to Day 1 of the phase.

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 full duration of the test.

Clinical signs:

other: No signs of toxicity were observed in male or female animals after treatment during the observation period. Brown staining on the dorsal region, due to the colour of the test item, was observed from day 2 up to day 4 of the observation period in females.

Gross pathology:

No abnormalities were found at necropsy examination performed on all
animals at termination of the study.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The results indicate that the test item, FAV-ES, has no toxic effect on the rat following dermal exposure over a 24 hour period at a level of 2000 mg/kg.The dermal LD50 of FAV-ES was determined to be > 2000 mg/kg.

Executive summary:

The acute toxicity of FAV ES was investigated following dermal administration of a single dose to the rat. A single dose of 2000 mg/kg was administered to a group of 5 male and 5 female animals for 24 hours. The test was carried out according to OECD and GLP guidelines.

After 14 days, all animals were killed and subjected to necropsy examination. No mortality occurred and no signs of toxicity were observed in male or female animals during the observation period. The body weight changes observed during the study were within the expected range for this species and age of animals. No abnormalities were found at necropsy in the animals at termination of the study, nor at the treated site. These results indicate that the test item, FAV ES, has no toxic effect on the rat following dermal exposure over a 24 hour period at a level of 2000 mg/kg. The lack of mortality demonstrates the LD50 to be greater than 2000 mg/kg.