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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:
6 - 16 March 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted: 2002
Deviations:
no
GLP compliance:
yes

Test material

1
Chemical structure
Reference substance name:
6-amino-5-chloro-2-cyclopropylpyrimidine-4-carboxylic acid
EC Number:
617-769-9
Cas Number:
858956-08-8
Molecular formula:
C8H8ClN3O2
IUPAC Name:
6-amino-5-chloro-2-cyclopropylpyrimidine-4-carboxylic acid

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, Pennsylvania, USA
- Age at study initiation: adult
- Weight at study initiation: 3830 g, 3024 g and 2979 g
- Housing: individual housed in stainless steel wire-mesh cages suspended above cage boards
- Diet: approximately 125 g of PMI® Nutrition International, LLC Certified Rabbit LabDiet® 5322 daily during the study
- Water: ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 22
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g moistened with 0.4 mL deionized water (a thick paste was formed)

Duration of treatment / exposure:
4 h
Observation period:
Reading time points: 1, 24, 48 and 72 h
Number of animals:
1 male (initial test)
2 males (confirmatory test)
Details on study design:
TEST SITE
- Area of exposure: 6 cm² on the scapular to the lumbar region of the back
- Type of wrap if used: The treated skin was covered with a 2-ply gauze pad and held in place with with non-irritating tape. The trunk of each rabbit was wrapped with porous tape. The tape was further secured with waterproof tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test sites were gently washed with warm water and gently patted dry.
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
1, 24, 48 and 72 h (The rabbit that was initially treated was also examined immediately after test substance removal. )

SCORING SYSTEM:
- Method of calculation: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other:
Remarks:
reversibility: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other:
Remarks:
reversibility: not applicable
Irritant / corrosive response data:
Erythema (score of 2 and 1) but no edema was observed on the test site of the first rabbit at 0 minutes and 60 minutes after test substance removal, respectively. At later time points, no skin reactions were observed. The remaining animals did not show signs indicative for dermal irritation during the study.
Other effects:
- Other adverse systemic effects: No clinical signs of toxicity were observed and no body weight loss occurred.

Any other information on results incl. tables

Table 1: Results of skin irritation study

Observation time

Rabbit no.

1 *

2

3

Erythema

Edema

Erythema

Edema

Erythema

Edema

0 h (Immediately after exposure)

2

0

-

-

-

-

1 h

1

0

0

0

0

0

24 h

0

0

0

0

0

0

48 h

0

0

0

0

0

0

72 h

0

0

0

0

0

0

Mean value
0 + 1 + 24 + 48 + 72 h

0.6

0.00

0.00

0.00

0.00

0.00

Mean value
24 + 48 + 72 h

0.00

0.00

0.00

0.00

0.00

0.00

*Initial rabbit tested

Table 2: Body weight

Rabbit number

sex

Initial weight (g)

Final weight (g)

1

male

2830

2834

2

male

3024

3053

3

male

2976

3046

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
A reliable study conducted in accordance with OECD 404 and GLP, found the test material to be non-irritating to the skin of rabbits. Mild erythema were only observed in one animal immediately after the exposure period and 1h after exposure, but were fully reversible within 24 h. No oedema were reported at any time point.