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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Details on test material:
-Purity: 100%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: Young adult
- Weight at study initiation: 2497, 2767 and 2969 g
- Housing: The animals were individually housed in suspended stainless steel caging with mesh floors
- Diet: Harlan Teklad Global High Fiber Rabbit Diet® #2031. A designated amount of the diet was available to each rabbit (approximately 150 grams/day).
- Water: Filtered tap water was supplied ad libitum.
- Acclimation period: 20-26 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23°C
- Humidity (%): 31-86%
- Air changes (per hr): 12 and 14
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mL
- Concentration (if solution): 100%

Duration of treatment / exposure:
4 hours of exposure
Observation period:
approximately 30-60 minutes, 24, 48, and 72 hours after patch removal
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: dorsal area and the trunk
- % coverage: test substance was applied to one 6-cm2 intact dose site on each animal
- Type of wrap if used: wrapped with semi-occlusive 3-inch Micropore tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours


SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: oedema noted on 1 animal at patch removal and at 30-60 minute time point
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
There was no dermal irritation observed for two treated dose sites. Oedema (score of 1) but no erythema was noted at one treated site immediately after patch removal and at the 30-60 minute scoring interval. Oedema cleared from the dose site by 24 hours.
Other effects:
All animals appeared active and healthy and gained body weight during the study.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
There was no dermal irritation observed for two treated dose sites. Oedema (score of 1) but no erythema was noted at one treated site immediately after patch removal and at the 30-60 minute scoring interval. Oedema cleared from the dose site by 24 hours.
Executive summary:

A primary skin irritation test was conducted with rabbits to determine the potential for the test substance to produce irritation after a single topical application. Five-tenths of a millilitre of the test substance was applied to the skin of one healthy rabbit for 4 hours. The dose site was evaluated for dermal irritation by the method of Draize et al. immediately after patch removal and at 30-60 minutes and 24, 48, and 72 hours after patch removal. Since there was no significant dermal irritation observed in this animal, the test was completed on two additional animals, as described above, except the dose sites were not evaluated immediately after patch removal. There was no dermal irritation observed for two treated dose sites. Oedema (score of 1) but no erythema was noted at one treated site immediately after patch removal and at the 30-60 minute scoring interval. Oedema cleared from the dose site by 24 hours.