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Diss Factsheets

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:
2002-05-21 to 2002-06-04
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study, to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Details on test material:
- Substance type: technical product
- Physical state: red viscous liquid
- Analytical purity: 'pure'
- Expiration date of the lot/batch: 2007-04
- 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: Covance Research Products, Denver PA, USA
- Age at study initiation: 2 males: 12-13 weeks; 1 male: 19-20 weeks
- Weight at study initiation: 2.34 to 3.39 kg
- Housing: singly housed in suspended stainless steel with wire mesh cages
- Diet (e.g. ad libitum): PMI Feeds, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 8 days (2 males); 50 days (1 male)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.8 to 22.2
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 /12

IN-LIFE DATES: From: 2002-05-21 To:2002-06-04

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: closely clipped at 48 and 24 h prior to dosing
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: 2.54 cm x 2.54 cm
- % coverage: no data
- Type of wrap if used: gauze patch held in place by non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with peanut oil/paper towels
- Time after start of exposure: 4 hours

SCORING SYSTEM: modified Draize (1959)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean: 24, 48, 72 hours
Score:
3.3
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean: 24, 48, 72 hours
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean: 24, 48, 72 hours
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: mean: 24, 48, 72 hours
Score:
2.2
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean: 24, 48, 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean: 24, 48, 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean: 24, 48, 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: mean: 24, 48, 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: mean: 24, 48, 72 hours
Score:
3.2
Max. score:
8
Reversibility:
not fully reversible within: 14 days
Irritant / corrosive response data:
Animal #1: at 72 h - erythema grade 4 and oedema grade 1 with blanching of test site
at 14 d - erythema grade 1 with desquamation

Animal #2: at 72 h - erythema grade 2 and oedema grade 1
at 14 d - no lesions

Animal #3: at 72 h - erythema grade 2 and oedema grade 1
at 14 d - desquamation

Other effects:
Blanching, eschar, cracking, exfoliation and desquamation

Any other information on results incl. tables

All animals survived to the end of the study and gained in weight.

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
In a GLP study conducted according to OECD guideline 404, semi-occluded exposure to undiluted test substance (0.5 ml) for 4 hours was moderately irritating to the skin of rabbits. The mean score for erythema was >2.3 in only 1/3 animals; therefore, the test material would not be classified as a skin irritant according to EU CLP criterion 1. However, as quite pronounced effects were seen in one animal, it is concluded that in accordance with EU CLP criterion 3, a precautionary classification as a skin irritant is warranted.
Executive summary:

In a GLP study conducted according to OECD guideline 404, the dermal irritation potential of the substance was evaluated in three male rabbits. 0.5 ml of the undiluted test material was applied to an area of closely clipped skin under a semi-occlusive patch and removed after 4 hours by wiping with peanut oil/paper towel. Animals were observed twice daily for viability (once at weekends) and clinical observations were made daily during the study. Body weights were recorded on days 0 and 14. Dermal responses were evaluated 1, 24, 48 and 72 hours after patch removal and on days 7, 10 and 14 using a modified Draize scoring system in which a maximum score of 4 is possible for erthyema and for oedema.

All animals survived to day 14 and gained body weight. Dermal irritation was seen within 1 hour of test substance removal, with all animals having grade 1 erythema and grade 1 oedema. Erythema increased, reaching grade 4 in one animal and grade 2 in the others, by 72 hours. No increase in oedema score was seen over this period. Both erythema and oedema scores decreased during the rest of the study, being fully reversible in 2/3 animals and with one animal having a slight erythema (grade 1) at day 14. Other lesions seen during the study were skin blanching in one animal at 48 and 72 hours only, eschar in one animal and cracking in two animals on day 7 only, exfoliation in two animals on day 10 only, and desquamation in two animals on day 14 only.

Mean erythema scores for 24, 48 and 72 hours were 3.3, 1.7 and 1.7, respectively, and mean oedema scores were 1 at each of the three timepoints. Since a mean erythema score of >2.3 was only seen in one of the three animals, the test material does not meet the first criterion for classification as a skin irritant according to EU CLP criteria. However, as quite pronounced effects were seen in one animal, it is concluded that in accordance with EU CLP criterion 3, a precautionary classification as a skin irritant is warranted.