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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April 9th, 1990 - April 17th, 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP - guideline study with acceptable restrictions. Lack of details on test substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
, lack of details on test substance.
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Glycerides, C14-18 and C16-22-unsatd. mono- and di-
EC Number:
294-574-1
EC Name:
Glycerides, C14-18 and C16-22-unsatd. mono- and di-
Cas Number:
91744-13-7
IUPAC Name:
91744-13-7
Details on test material:
- Name of test material (as cited in study report): Glycerides, C14-18 and C16-22-unsatd. mono- and di-
- Physical state: brownish liquid
- Analytical purity: no data
- Lot/batch No.: 0189-0-040

Test animals

Species:
rabbit
Strain:
other: Kleinrussen, Chbb:HM
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Thomae, Biberach, Germany.
- Age at study initiation: 19-20 months
- Weight at study initiation: approx. 2770 g
- Housing: individually
- Diet (e.g. ad libitum): Altromin 2023, Lage, Germany
- Water (e.g. ad libitum): tap water
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 45-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light):12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated site of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: Dorsum
- % coverage: approx. 6 cm2
- Type of wrap if used: gauze, adhesive hypoallergenic tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): none

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean of 3 readings at
Time point:
other: 24, 48 and 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean of 3 readings at
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean of 3 readings at
Time point:
other: 24, 48 an 72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean of 3 readings at
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
mean of 3 readings at
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
mean of 3 readings at
Time point:
other: 24, 48 and 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 7 days

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU