Registration Dossier

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:
25 May - 28 May 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:
EPA OPP 81-5 (Acute Dermal Irritation)
Deviations:
yes
Remarks:
purity of test substance not given.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): [trade name] C10-18 TRIGLYCERIDE
- 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 and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd., Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.24-2.64 kg
- Housing: individually in suspended metal cages
- Diet: Rabbit Diet (Preston Farmers Ltd., Lincolnshire, UK), ad libitum
- Water: ad libitum
- Acclimation period: 5 days

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: shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: not required, 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 h
Observation period:
72 h
Reading time points: 1, 24, 48 and 72 h
Number of animals:
6 males
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
- Washing (if done): any residual test material was removed by gentle swabbing with cotton wool soaked in diethyl ether.
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: mean over 24, 48 and 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: mean over 24, 48 and 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
1 h post-application: slight erythema was observed in 1/6 animals.
24 h post-application: slight erythema was observed in 1/6 animals.
48 h post-application: slight erythema was observed in 3/6 animals. In one of these animals, the reaction extended up to 4 cm beyond the treatment site.
72 h post-application: no skin reactions were noted.
No edema was observed in any animal at any reading time point.
Other effects:
No further local or systemic effects were reported.

Any other information on results incl. tables

Table1 . Results of skin irritation study.

Observation time Rabbit no.
1 2 3 4 5 6
Erythema Edema Erythema Edema Erythema Edema Erythema Edema Erythema Edema Erythema Edema
1 h 0 0 0 0 0 0 1 0 0 0 0 0
24 h 0 0 0 0 0 0 1 0 0 0 0 0
48 h 1 0 0 0 0 0 1 0 0 0 1 0
72 h 0 0 0 0 0 0 0 0 0 0 0 0
Mean value 24 + 48 + 72 h 0.33 0.00 0.00 0.00 0.00 0.00 0.67 0.00 0.00 0.00 0.33 0.00
Mean value 24 + 48 + 72 h all animals 0.22 0.00                    

Applicant's summary and conclusion

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