Registration Dossier

Diss Factsheets

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:
From19 MAY 2011 to 20 JUN 2011
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given: comparable to guidelines/standards

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: ISO 10993-10:2010
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-[[1-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-oxopropyl]azo]benzoic acid
EC Number:
250-830-4
EC Name:
2-[[1-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-oxopropyl]azo]benzoic acid
Cas Number:
31837-42-0
Molecular formula:
C18H15N5O5
IUPAC Name:
2-({2-oxo-1-[(2-oxo-2,3-dihydro-1H-benzimidazol-5-yl)carbamoyl]propyl}diazenyl)benzoic acid
Test material form:
not specified

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source:DNA Rabbitry, Elk River, MN, CANADA
- Age at study initiation: young adults
- Weight at study initiation: 2.2 to 2.3 kg
- Housing: individually housed in suspended stainless steel caging
- Diet: certified commercial animal feed
- Water: potable water from the St. Paul municipal water supply
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- environmental conditions in the animal rooms were maintained according to WuXiAppTec SOP:ILS-0018. The temperature and photoperiod were set to meed the Assessment and Accreditation of Laboratory Animal Care (AAALAC) International recommendations for these species

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 x 0.5 g/animal (i.e.: 0.5 g/patch) wetted with tap water

Duration of treatment / exposure:
24 h
Observation period:
1, 24, 48 and 72 h after end of exposure
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 1x1 inch, one patch with test material and one control patch was applied on each side of the vertebral column, i.e. two patches with test material were applied to each animals back
- Type of wrap if used: elastic bandage and hypoallergenic tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with diluted alcohol, slightly swab
- Time after start of exposure: 24 hours (directly after unwrapping )

SCORING SYSTEM: erythema and edema scoring according to Draize system (cf OECD 404)

CALCULATION OF MEAN SCORES: the mean of the 24, 48 and 72 h readings from two patches (i.e. mean of 6 readings / animal) was calculated for each animal

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean of 24, 48 and 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: animal treated at two sides
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean of 24, 48 and 72 h
Score:
0.17
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: animal treated at two sides
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable since no effects
Remarks on result:
other: animal treated at two sides
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable since no effects
Remarks on result:
other: animals treated at two sides
Irritant / corrosive response data:
Animal #1 showed a very slight erythema (score = 1) 24 hours after patch removal on the right side of the back, which was gone at the 48 hours reading. At the 48 Hour reading there was a very slight erythema on the left side, which was gone at the 72 hour reading.
Animal #2 showed a very slight erythema 24 hours after patch removal on one side of the back (Score = 1), which was gone at the 48 h reading.
Animal #3 showed no reaction at any reading (erythema and edema score 0).

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Under the applied test conditions the tes titem did not show any remarkable irritation potential onto the skin of rabbits.
Executive summary:
The primary skin irritation potential of the test item was investigated according to ISO 10993 -10:2010. The test item (0.5 g wetted with tap water) was applied to the intact skin of three New Zealand White rabbits under semi-occlusive conditions for 24 hours (one patch with test material on each side of the vertebral column). The scoring of the skin reactions was performed 1, 24, 48 and 72 hours after removal of the test item. The mean score of the 24, 48 and 72 h readings from two patches was calculated for each animal. No edema was observed at any time point (score 0) and only very slight erythema were seen in two animals (score 1) which were reversible after 72 hours at the latest. There was no indication of systemic toxicity.