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:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Published data, it failed details on experimetal conditions
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
publication
Title:
Evaluation of the cutaneous-irritation potential of 56 compounds.
Author:
J.P.Guillot, J.F. Gonnet, C. Clement, L. Caillard, R.Truhaut.
Year:
1982
Bibliographic source:
Fd Chem. Toxic, vol.20, 563-572.

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
: no detail on the animal and environmental conditions, use of an occlusive dressing. No information on individual irritation scores, therefore, skin reactions were not assessed with OECD Recommended Scoring System.
Principles of method if other than guideline:
Standard Draize method. The irritancy of the test item was then defined on the basis of the the primary dermal irritation index (PDII) using the scale appropriate for AFNOR protocol.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
gas under pressure: refrigerated liquefied gas
Details on test material:
- Name of test material (as cited in study report): o-Diethyoxybenzene
- Substance type: no data
- Physical state: colourless liquid
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Purity test date: no data
- Lot/batch No.: TIL 4626
- Stability under test conditions: no data
- Storage condition of test material: no data

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Roucher SA, Couhé.
- Age at study initiation: no data
- Weight at study initiation: 2.5 kg.
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data

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

IN-LIFE DATES: no data

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): not applicable, the test substance is applied undiluted

VEHICLE: not applicable, the test substance is applied undiluted

Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours after patch removal
Number of animals:
six animals (Males)
Details on study design:
TEST SITE
- Area of exposure: dorsal surface of the trunk
- % coverage: approx. 6 cm2
- Type of wrap if used: occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: 4 hours

SCORING SYSTEM:
Each treated area was scored for erythema and oedema according to the method of Draize (describe in: Draize, J. H., Woodard, G.& Calvery, H. O. (1948). Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes. Pharmacol. 93, 377.)
Criteria used for interpretation based on Primary Dermal Irritation Index (PDII) according to AFNOR scale:
PDII below 0.5.................non irritant
0.5-3................................slightly irritant
3-5...................................moderately irritant
5-8...................................severely irritant

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 1, 24, 48, 72 hours
Score:
0.21
Max. score:
8
Reversibility:
fully reversible within: 3 days
Irritant / corrosive response data:
As primary dermal irritation index (PDII) is 0.21. PDII is below 0.5 according to AFNOR scale, therefore, o-Diethoxybenzene is considered as not irritating to skin (see Table 7.3.1/1).
Other effects:
No data

Any other information on results incl. tables

Table 7.3.1/1: summary table of irritation scores results and PDII

Score at time point/reversibility

Erythema + Oedema (six animals)

Conclusion (Draize method)

60 min

4

Not irritating

 

(PDII below 0.5 )

24 h

4

48 h

2

72 h

0

PDII = 10/48 = 0.21 (Max: 8)

 

7 days

/

14 days

/

Reversibility

Yes, within 3 days

 

PDII*: the sum ((erythema + oedema) in all six animals at the reading times)/the total number of readings

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: AFNOR (1982)
Conclusions:
Under the test conditions, o-Diethyoxybenzene is not considered to be a skin irritant.
Executive summary:

In a non-GLP primary dermal irritation study (Guillot and al, 1982) performed similarly to the OECD No. 404, six male New Zealand White rabbits were dermally exposed to 0.5 mL of undiluted o-Diethyoxybenzene to the dorsal surface of the trunk (skin was clipped before application) for 4 hours under an occlusive dressing. Skin reactions were assessed 1, 24, 48 and 72 hour after patch removal using the Draize scale. The irritancy of the test item was then defined on the basis of the the primary dermal irritation index (PDII) using the scale appropriate for AFNOR.

PDII is 0.21, the test substance was therefore considered as non-irritant to the skin.

Under the conditions of this test, no classification for skin irritation is required according to the criteria of the CLP Regulation (EC) N°1272/2008 and the Directive 67/548/EEC.