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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
May 25th, 1988 - May 28th, 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
Deviations:
yes
Remarks:
Purity of test substance not given.
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Glycerides, C12-18
EC Number:
266-944-2
EC Name:
Glycerides, C12-18
Cas Number:
67701-26-2
IUPAC Name:
67701-26-2
Constituent 2
Reference substance name:
C12-C18 trialkyl glyceride
IUPAC Name:
C12-C18 trialkyl glyceride
Details on test material:
- Name of test material (as cited in study report): C10-18 TRIGLYCERIDE
- Name of test material: Hydrogenated Coco-Glycerides
- Physical state: white, waxy solid
- Analytical purity: no data
- Stability under test conditions: not determined
- Storage condition of test material: room temperature
- Date of arrival 23 March 1988

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd., Cheshire, U.K.
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.24 - 2.64 kg
- Housing: individually in suspended metal cages
- Diet (e.g. ad libitum): Rabbit Diet, Preston Farmers Ltd., Lincolnshire, U.K.
- Water (e.g. ad libitum): yes
- Acclimation period: 5d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 - 20
- Humidity (%): 68 - 75
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated sites of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
The test material was warmed to approx. 40 ºC and applied as a liquid to the skin
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: dorsal flank area
- % coverage: 2.5 cm x 2.5 cm
- Type of wrap if used: gauze patch, surgical adhesive tap, elasticated corset (TUBIGRIP)

REMOVAL OF TEST SUBSTANCE
After exposure period of 4 h any residual test material was removed by gentle swabbing with cotton wool soaked in diethyl ether.

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean of
Time point:
other: 24, 48 and 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean of
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean of
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #4
Remarks:
mean of
Time point:
other: 24, 48 and 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
erythema score
Basis:
animal #5
Remarks:
mean of
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #6
Remarks:
mean of
Time point:
other: 24, 48 and 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 6 tested animals and mean of
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4

Applicant's summary and conclusion

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