Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Repeated dose toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
short-term repeated dose toxicity: dermal
Type of information:
experimental study
Remarks:
OECD 410
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test conducted in the spirit of guideline OECD 410 and GLP.
Remarks:
as the tested substance is not the registered substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)
GLP compliance:
yes
Remarks:
in the spirit of

Test material

Constituent 1
Reference substance name:
Reaction mass of palmitic acid and stearicacid and linoleic acid and oleic acid and docosanoic acid and linolenic acid and icosanoic acid
Molecular formula:
Not relevant for a UVCB substance
IUPAC Name:
Reaction mass of palmitic acid and stearicacid and linoleic acid and oleic acid and docosanoic acid and linolenic acid and icosanoic acid
Test material form:
liquid
Details on test material:
The tested material is a mixture containing 99% corn oil oxidized (glycerides, C10-C20 sat. and unsat.) and 1% fragrance.

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals or test system and environmental conditions:
Test carried out on 12 animals having damaged skin.

Administration / exposure

Type of coverage:
open
Details on exposure:
The substance to be studied is applied on the right flank of each animal, at 0.5 ml od susbtance, uniformely. This applciation is not followed by massage. The rabbits are then kept in con tainement cages during about 30 minutesin order to avoid the ingestion of the substance. The left flank is not treated.
Duration of treatment / exposure:
14 days
Frequency of treatment:
2 times / day, morning and evening, 7 days per week.
Doses / concentrations
Remarks:
Doses / Concentrations:
0.5 ml / 25cm²
Basis:
analytical per unit area
No. of animals per sex per dose:
12 males
Control animals:
yes

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Dermal irritation:
effects observed, treatment-related
Description (incidence and severity):
slightly irritating
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Food efficiency:
no effects observed
Water consumption and compound intake (if drinking water study):
no effects observed
Ophthalmological findings:
not specified
Histopathological findings: neoplastic:
effects observed, treatment-related
Description (incidence and severity):
slight skin irritation
Details on results:
The product is slightly irritant to skin when applied daily on the back of neo zealander rabbit during 14 days.

Effect levels

Key result
Dose descriptor:
NOAEL
Effect level:
> 0 - < 0.02 other: ml/cm2
Based on:
test mat.
Sex:
male
Basis for effect level:
dermal irritation

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Corn oil applied on daily on rabbit damaged skin during 14 days is slightly irritant to rabbit skin.