Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
not indicated
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study performed in 1975, non-GLP, but appropriate for this endpoint.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Principles of method if other than guideline:
Patch-test technique on the intact and abraded skin of albino rabbits.
GLP compliance:
no
Remarks:
test was performed before GLP principles were in place.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Dianol 33
no information on Cas nr and purity.

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved or shaved and abraded
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 grams
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
12
Details on study design:
TEST SITE
- Area of exposure: not indicated
- % coverage: 1 inch x 1 inch
- Type of wrap if used: impervious tape to retard evaporation.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: at 24h and 48 hours later (72 hours after application)

SCORING SYSTEM:Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: mean of erythema and edema score
Basis:
mean
Time point:
other: 24 h
Score:
0.8
Max. score:
2
Remarks on result:
other: intact skin; edema score is 0 in all animals
Irritation parameter:
other: probably mean of erythema and edema score
Basis:
mean
Time point:
other: 72 h
Score:
0.7
Max. score:
1
Remarks on result:
other: intact skin
Irritation parameter:
other: mean of erythema and edema score
Basis:
mean
Time point:
other: 24 h
Score:
1.8
Max. score:
2
Remarks on result:
other: abraded skin
Irritation parameter:
other: probably mean of erythema and edema score
Basis:
mean
Time point:
other: 72 h
Score:
1
Max. score:
1
Remarks on result:
other: abraded skin
Irritant / corrosive response data:
The available in vivo test on skin irritation for Dianol 33 is not according to current guidelines. Exposure was during 24 h on intact and abraded skin under occlusion. See included table for results.

Any other information on results incl. tables

Dianol 33

Intact skin

Abraded skin

Rabbit nr

24h erythema

24h edema

72h

Rabbit nr

24h erythema

24h edema

72h

1

0

0

0

7

2

0

1

2

0

0

1

8

2

1

1

3

1

0

0

9

1

0

1

4

1

0

1

10

1

0

1

5

2

0

0

11

2

0

1

6

1

0

1

12

2

0

1

average

0.8

0.7

 

1.8

1.0

 24 h reading is directly after removal of the patches (with 24 h exposure), 72 h reading is 48 hours after first reading.

Applicant's summary and conclusion

Interpretation of results:
other: Slightly irritating to skin, but insufficient for classification.
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Dermal exposure of Dianol 33 was tested during 24h under occlusive conditions on both intact and abraded skin. Although this study was not performed according to current guidelines, the exposure conditions are more worst case than required by guidelines and are considered acceptable for conclusion on skin irritating properties of Dianol 33. Based on the observed slight irritation of exposed abraded skin after 24h of exposure, which effect was decreased after another 48h (mean score is 1 at 72h ), Dianol 33 does not have to be classified and has no obligatory labelling requirement for dermal irritation according to the:
- Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2007),
- Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.