Isooctadecanoic acid, mixed esters with oxybis[propanediol]

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

24 Feb. - 09 March 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

24 February 1987

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

OGYEI National Institute of Pharmacy and Nutrition, H-1051 Budapest, Zrinyi u. 3, 1372 P.O. Box: 450, Hungary

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Isooctadecanoic acid, ester with oxybis[propanediol]

EC Number:

277-361-8

EC Name:

Isooctadecanoic acid, ester with oxybis[propanediol]

Cas Number:

73296-86-3

Molecular formula:

C24H50O7

IUPAC Name:

16-methylheptadecanoic acid; 3-(2,3-dihydroxypropoxy)propane-1,2-diol

Test animals

Species:

rat

Strain:

Wistar

Remarks:

CRL:(WI)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, D-97633 Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: young healthy adults
- Weight at study initiation: 214 - 252 g
- Housing: individually in Type II polypropylen/polycarbonate cages with deep wood sawdust to allow digging
- Bedding: Lignocel 3/4-S Hygienic Animal Bedding (J. Rettenmaier & Söhne GmbH & Co. KG, D-73494 Rosenberg, Germany
- Diet: ssniff SM R/M diet (ssniff Spezialdiäten GmbH, D-59494 Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.9 - 24.9
- Humidity (%): 24 - 58
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: 24 February - 9 March 2016

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: back of each animal
- % coverage: approx. 10
- Treatment of test site: shaving, 24 h prior to administration
- Type of wrap if used: sterile gauze pad kept in contact with the skin using a patch with adhesive hypoallergenic plaster, the entire trunk of each animal was wrapped with a semiocclusive plastic wrap

REMOVAL OF TEST SUBSTANCE
- Washing: residual material was removed with water of body temperature
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount applied: a single dose of 2000 mg/kg bw of the test item was administered

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males, 5 females

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: on Day 0 at 1 and 5 h after application, once each day for 14 days thereafter
- Frequency of weighing: Day 0 (before administration), Days 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross macroscopic examination

Results and discussion

Preliminary study:

The test item was not expected to be lethal at 2000 mg/kg bw. A limit test with a single dose of 2000 mg/kg bw was therefore performed.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

The test item did not cause mortality at the dose level of 2000 mg/kg bw.

Clinical signs:

There were no systemic clinical signs noticed in any animal throughout the study.

Body weight:

Body weight gain of all animals showed no indication of a test item-related effect.

Gross pathology:

There was no evidence of any adverse effect in the macroscopic observations.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.