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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
29 September to 2 October 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
413-110-2
EC Name:
-
Cas Number:
135861-56-2
Molecular formula:
C24H30O6
IUPAC Name:
(1R)-1-[(4R,4aR,8aS)-2,6-bis(3,4-dimethylphenyl)tetrahydro[1,3]dioxino[5,4-d][1,3]dioxin-4-yl]ethane-1,2-diol
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Gel All DX
- Substance type: white powder
- Physical state: solid
- Storage condition of test material: room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12 to 16 weeks
- Weight at study initiation: 2.56 to 2.61 kg
- Housing: animals were housed individually in suspended metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 20 °C
- Humidity (%): 58 to 78 %
- Air changes (per hr): 15 per hour
- Photoperiod (hrs dark / hrs light): 12/ 12
- on 2 occasions the relative humidity was above the limit specified in the study protocol (70 %). This deviation was considered not to affect the purpose or integrity of the study.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: moistened with water
Controls:
no
Amount / concentration applied:
0.5 g of the test material, moistened with 0.5 mL of distilled water
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm cotton gauze patch secured with surgical adhesive tape
- Type of wrap if used: the trunk of each animal was wrapped in an elasticated corset (TUBIGRIP)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test material was removed by gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scheme

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
(Animal 2 - male)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Score of 1 at 1 hour observation
Irritation parameter:
erythema score
Basis:
mean
Remarks:
(Animal 27 - male)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: No erythema/eschar observed at any observation
Irritation parameter:
erythema score
Basis:
mean
Remarks:
(Animal 167 - female)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Score of 1 at 1 hour observation
Irritation parameter:
edema score
Basis:
mean
Remarks:
(Animal 2 - male)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: No edema observed at any observation
Irritation parameter:
edema score
Basis:
mean
Remarks:
(Animal 27 - male)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: No edema observed at any observation
Irritation parameter:
edema score
Basis:
mean
Remarks:
(Animal 167 - female)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: No edema observed at any observation
Irritant / corrosive response data:
The individual scores for erythemaleschar and oedema, are given in Table 1 (see attached background material)
Mean values required for EU labelling regulations are given in Table 2 (see attached background material).

Very slight erythema was noted in 2 treated skin sites 1 hour after patch removal. All treated skin sites appeared normal at the 24-hour observation.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The skin irritancy potential of the test material was assessed according to OECD guideline 404. The test material produced a primary irriation of 0.0 and was classified as a non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

The test material does not meet the criteria for classification as irritant or corrosive according to Regulation (EC) No. 1272/2008 (CLP).
Executive summary:

A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method used followed the recommendations of the OECD Guidelines for Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion) and Method B4 of Commission Directive 92/69/EEC).

A single 4-hour, semi-occluded application of the test material to the intact skin of 3 rabbits produced very slight erythema. All treated skin sites appeared normal at the 24-hour observation.

The test material produced a primary irritation of 0.0 and was classified as a non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

The test material does not meet the criteria for classification as irritant or corrosive according to Regulation (EC) No. 1272/2008 (CLP).