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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Remarks:
The study was conducted according to the guideline in effect at study conduct.
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
Remarks:
The study was conducted according to the guideline in effect at study conduct.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Purity: 97.59%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: Young adult
- Weight at study initiation: 2594, 2617, 2498 g
- Housing: singly in suspended stainless steel cages with mesh floors. Litter paper was placed beneath the cage and was changed at least 3 times per week.
- Diet (e.g. ad libitum): ad libitum, Pelleted Purina Rabbit Chow #5326
- Water (e.g. ad libitum): ad libitum, filtered tap water
- Acclimation period: 13 or 20 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22ºC
- Humidity (%): 49-64%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
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:
Approximately 30-60 minutes and 24, 48, and 72 hours after patch removal
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm²
- % coverage: 100%
- Type of wrap if used: The dose site was covered with a 1-inch x 1 inch, 4-ply gauze pad. The pad and entire trunk of each rabbit was wrapped with semi-occlusive tape. Elizabethan collars were placed on each rabbit.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): test substance removed and the test sites gently cleansed of any residual test substance.
- Time after start of exposure: After 4 hours of exposure.

SCORING SYSTEM: Draize scoring system.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean of the 24-, 48-, and 72-hour dermal responses (EEC/GHS)
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean of the 24-, 48-, and 72-hour dermal responses (EEC/GHS)
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean of the 24-, 48-, and 72-hour dermal responses (EEC/GHS)
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean of the 24-, 48-, and 72-hour dermal responses (EEC/GHS)
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean of the 24-, 48-, and 72-hour dermal responses (EEC/GHS)
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean of the 24-, 48-, and 72-hour dermal responses (EEC/GHS)
Score:
0
Max. score:
4
Irritant / corrosive response data:
Within one hour after patch removal following the 4-hour exposure, very slight erythema and/or very slight edema were noted for all three treated dose sites. The incidence and severity of irritation decreased with time. All animals were free from dermal irritation within 72 hours. The dermal scores from individual animals with respect to observation time are presented in Table 1.
Other effects:
All animals appeared active and healthy during the study. Apart from the dermal irritation there were no other signs of gross toxicity, adverse pharmacologic effects, or abnormal behaviour.

Any other information on results incl. tables

Table 1: Individual Skin Irritation Scores; Erythema/Edema

 

 

Time After patch Removal

Animal No.

Sex

30-60 mins

24 hrs

48 hrs

72 hrs

3501

M

1/1

1/1

0/0

0/0

3502

M

1/0

1/0

1/0

0/0

3503

M

1/0

1/0

0/0

0/0

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: Directive 67/548/EEC; Globally Harmonized System (GHS)
Conclusions:
Within one hour after patch removal following the 4-hour exposure, very slight erythema and/or very slight edema were noted for all three treated dose sites. The incidence and severity of irritation decreased with time. All animals were free from dermal irritation within 72 hours.

The study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability).
Executive summary:

The dermal irritation study was conducted in a stepwise manner. Five-tenths of a millilitre of the test substance was initially applied to the skin of one rabbit for 4-hours. Within one hour after patch removal, the dose site was evaluated for dermal irritation by the method of Draize et al. Additional evaluations of each dose site were performed at 24, 48, and 72 hours after patch removal. Since irritation cleared by 72 hours and there was no corrosive effect observed in this animal, the test was completed with two additional animals. Within one hour after patch removal, very slight erythema and/or very slight edema were noted for all three treated dose sites. The incidence and severity of irritation decreased with time. All animals were free from dermal irritation within 72 hours.