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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
17th August 1991 - 2nd Decmber 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- lot/batch No.of test material: 9059

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: The test material, a colourless liquid, was stored in the dark under ambient conditions.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Interfauna UK Limited, Abbots Ripton Road, Wyton, Huntingdon
- Age at study initiation: young adult
- Housing: The rabbits were housed individually in aluminium cages with grid floors beneath which were peat moss filled trays.
- Diet: Standard Rabbit Diet, supplied by Special Diets
Services, 1 Stepfield, Witham, Essex, CM8 3AD ad libitum
- Water: tap water ad libitum
- Acclimation period: 13 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-20 °C
- Humidity (%): 57%
- Photoperiod (hrs dark / hrs light): A 12 h light/dark cycle was in operation

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: Ethylene glycol diethyl ether (ethyl glyme),
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5 mL
- Concentration (if solution):undiluted

0.5mL of the control material, ethylene glycol diethyl ether (ethyl glyme) was also applied.
Duration of treatment / exposure:
4 hrs
Observation period:
1, 24, 48 and 72 h after patch removal. Further assessments were carried out at 5, 6, 8, 9, 10 and 11 days after patch removal to determine the reversibility of responses.
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: The hair was clipped from the dorsal area of the trunk of each rabbit approximately 24 h before treatment. Care was taken to avoid abrading the skin.
- % coverage: The test and control materials (0.5 ml) were applied to intact skin on each rabbit under 2.5 cm x 2.5 cm patches of gauze.

- Type of wrap if used: Due to the volatility of the test material, the patches were covered with Sleek, an occlusive dressing, which remained in position for 4 h.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The patches were removed and the skin wiped with water dampened tissues to remove surplus test material without altering the existing response or the integrity of the epidermis.
- Time after start of exposure: After 4 hr exposure period

OBSERVATION TIME POINTS
(indicate if minutes, hours or days)
1, 24, 48 and 72 h after patch removal. Further assessments were carried out at 5, 6, 8, 9, 10 and 11 days after patch removal to determine the reversibility of responses.

SCORING SYSTEM:
- Method of calculation: The daily scores for erythema and oedema for the test and control material at the 24, 48 and 72 h assessments were totalled and the mean was calculated. This mean value is expressed as a mean irritation score for each material. The Draize scoring system was used (Appendix).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
other: animals 1 & 2
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
other: animals 1 & 2
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritation parameter:
erythema score
Basis:
other: animals 1 & 2
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 11 days
Remarks:
Erythema = 1
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 11 days/Erythema = 1
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
overall irritation score
Remarks:
erythema
Basis:
animal: 1,2,3
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
not fully reversible within: 11 days
Remarks:
Animal #3 erythema = 1
Irritation parameter:
overall irritation score
Remarks:
oedema
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
overall irritation score
Remarks:
oedema
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
overall irritation score
Remarks:
oedema
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritant / corrosive response data:
Following a 4 h application of both the test and control materials, very slight to well defined erythema and very slight to slight oedema were noted up to 72 h after patch removal. At 5 days skin reactions deteriorated at a test site treated with test material and a test site treated with control material on one rabbit.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In an in vivo skin irritation study in male New Zealand rabbits, the substance 1,2-Diethoxypropane was not irritating.
Executive summary:

In a primary dermal irritation study (8280), 3 male rabbits were dermally exposed (dorsal area of the trunk; occlusive) to 0.5mL of undiluted 1,2-Diethoxypropane for 4 hours. The substance was removed after 4 hrs with washing. Animals were observed at 24, 48 and 72 hrs for overall irritation scores and up to 11 days for reversibility. Irritation was scored by the method of Draize.

The overall irritation score (erythema) for all animals was 1.33. In only 1 animal (#3) the irritation was not fully reversible at Day 11 (erythema = 1). The overall irritation score (oedema) for animal #1 was 0. The overall irritation score (oedema) for animal #2 was 1.33 (fully reversible within 10 days). The overall irritation score (oedema) for animal #3 was 0.66 (fully reversible within 8 days). The observations were not extended to 14 days. In only 1 animal (#3) was the erythema not fully reversible at Day 11 (erythema = 1). Overall, based on the CLP criteria, the substance is not irritating.