Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: dermal

Currently viewing:

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

Constituent 1
Chemical structure
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.