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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16 Dec - 30 Dec 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No. 8147, November 2000
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Glycerides, C8-18 and C18-unsatd. mono- and di-, acetates
EC Number:
293-170-2
EC Name:
Glycerides, C8-18 and C18-unsatd. mono- and di-, acetates
Cas Number:
91052-13-0
Molecular formula:
not applicable for UVCB substances
IUPAC Name:
Glycerides, C8-18 and C18-unsatd. mono- and di-, acetates
Details on test material:
- Name of test material (as cited in study report): only trade name given
- Physical state: light yellow transparent oily liquid
- Analytical purity: 100%
- Lot/batch No.: H113021
- Expiration date of the lot/batch: 05 November 2010 (allocated by the testing laboratory, 1 year after receipt of the test substance)
- Storage condition of test material: room temperature, dark

Test animals

Species:
rat
Strain:
other: Wistar Crl:WI (Han) (outbred, SPF-Quality)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: 277 - 304 g (males) and 184 - 202 g (females)
- Housing: individually housed in labelled Macrolon cages (Mlll type) containing sterilised sawdust as bedding material (Litalabo, S.P.P.S., Argenteuil, France) and paper as cage-enrichment (Enviro-dri, Wm. Lillico & Son (Nonham Mill Ltd), Surrey, UK).
- Diet: pelleted rodent diet (SM R/M-Z from SSNlFF® Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 ± 3.0
- Humidity (%): 40-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
occlusive
Vehicle:
polyethylene glycol
Details on dermal exposure:
TEST SITE
- Area of exposure: approx. 25 cm² on the dorsal area (males) and 18 cm² (females), respectively
- % coverage: 10%
- Type of wrap if used: dressing consisting of a surgical gauze patch (Surgy 1D, Laboratoires Stella sa., Liege, Belgium), successively covered with aluminum foil and Coban elastic bandage (3M, St. Paul, MN, USA.). A piece of Micropore tape (3M, St. Paul, MN, USA) was additionally used for fixation of the bandages in females only.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test substance was removed with tap water.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 mL/kg bw
- Concentration (if solution): 200 mg/mL
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed twice daily for mortality and viability, and individual body weights were determined at Day 1 (pre-administration), 8 and 15; clinical signs were determined at periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

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 study period.
Clinical signs:
other: Flat posture was noted among all animals on Day 1. Chromodacryorrhoea was observed in 3/5 males and in 2/5 females on Day 1. Ptosis was determined in 2/5 males and in 4/5 females. 3/5 females showed restless behaviour on Day 1. Scales and scabs of the rig
Gross pathology:
Necropsy revealed no substance-related findings.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified